Lurbinectedin History and Updates

189 events · 2011 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

FDA Approvals

Label Revisions

183

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Lurbinectedin since 2011, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (7)

2026

Primary completionLurbinectedin Phase 3 LAGOON Trial for Relapsed SCLC Completes Primary Study· Apr 30, 2026
Primary completionLurbinectedin Phase 3 Trial for Relapsed SCLC Completes Primary Study· Apr 10, 2026
Results postedTarlatamab in Relapsed SCLC Improves Overall Survival vs. Standard of Care· Jan 5, 2026

2025

FDA approval (supplemental)Zepzelca Receives FDA Supplemental Efficacy Approval· Oct 2, 2025
Results postedLurbinectedin Exposure Decreases with Bosentan Co-administration in Solid Tumors· Sep 16, 2025
Results postedLurbinectedin: Itraconazole Co-administration Increases Exposure in Advanced…· Sep 2, 2025
Results postedLurbinectedin Monotherapy Shows Limited ORR in Advanced Solid Tumors· Feb 28, 2025

Upcoming & expected milestones

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05876715

LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma

Trial startedJun 30, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07640932

Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer

Primary completionJul 28, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT05244239

Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer

Primary completionJul 31, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05099666

Lurbinectedin + Doxorubicin In Leiomyosarcoma

Primary completionSep 1, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT04607954

Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer

Trial startedOct 31, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07258147

Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases

Primary completionNov 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05574504

Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy

Primary completionDec 25, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05578326

Study of Trilaciclib and Lurbinectidin

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06497530

Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT05636111

Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer

Primary completionMar 1, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07121478

Patients With High-grade Pancreatic Neuroendocrine Tumors

Primary completionApr 30, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07640932

Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer

Primary completionApr 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06203210

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

Primary completionJul 30, 2027· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05918640

Lurbinectedin in FET-Fused Tumors

Primary completionSep 1, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT06228066

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07258147

Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06496048

Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC

Primary completionJan 28, 2028· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05734066

Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma

Primary completionJan 31, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07459634

A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC

Primary completionAug 1, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT05800587

Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer

Primary completionApr 30, 2029· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07153055

Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

Primary completionMay 31, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT07155174

A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab

Primary completionAug 30, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT06088290

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leio

Primary completionOct 31, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT06801834

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Primary completionDec 31, 2029· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06681220

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

Primary completionJun 30, 2030· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07141771

An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing

Primary completionSep 30, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT07365241

A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With

Primary completionOct 1, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT07328425

Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS

Past events

2026

Trial startedJun 12, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07459634

A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC

Trial registeredJun 11, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07640932

Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer

Trial startedMay 31, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07153055

Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

Primary completionMay 31, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06217536

Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas

Primary completionApr 30, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05153239

Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed S

Trial startedApr 25, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07459634

A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC

Trial startedApr 14, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07365241

A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With

Primary completionApr 10, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05153239

Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed S

Trial registeredMar 10, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07459634

A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC

FDA approval (supplemental)Feb 27, 2026· FDA

FDA approved supplemental application for Zepzelca (lurbinectedin) — Labeling (NDA 213702 S-12)

Sponsor: JAZZ. Class: Labeling.

Trial startedFeb 23, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06681220

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

Trial registeredJan 26, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07365241

A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With

Trial registeredJan 9, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07328425

Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS

Results postedJan 5, 2026· ClinicalTrials.gov

Trial results posted: NCT05740566

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

2025

Trial startedDec 31, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07141771

An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing

Results postedDec 29, 2025· ClinicalTrials.gov

Trial results posted: NCT05091567

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With

Primary completionDec 17, 2025· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04802174

Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers

Trial registeredDec 2, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07258147

Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases

Trial startedNov 25, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07155174

A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab

Trial startedNov 21, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07328425

Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS

FDA approval (supplemental)Oct 2, 2025· FDA

FDA approved supplemental application for Zepzelca (lurbinectedin) — Efficacy (NDA 213702 S-11)

Sponsor: JAZZ. Class: Efficacy.

Trial startedSep 23, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07121478

Patients With High-grade Pancreatic Neuroendocrine Tumors

Results postedSep 16, 2025· ClinicalTrials.gov

Trial results posted: NCT05072106

Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors

Trial registeredSep 4, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07155174

A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab

Trial registeredSep 3, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07153055

Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

Results postedSep 2, 2025· ClinicalTrials.gov

Trial results posted: NCT05063318

Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors

Trial registeredAug 26, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07141771

An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing

Trial registeredAug 13, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07121478

Patients With High-grade Pancreatic Neuroendocrine Tumors

Primary completionAug 4, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05229588

Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations

Primary completionJul 1, 2025· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT02611024

Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors

Primary completionJun 30, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT06497530

Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC

Primary completionJun 4, 2025· ClinicalTrials.gov

Primary completion: NCT04894591

To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)

Primary completionJun 1, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT05101265

Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment

FDA approval (supplemental)Apr 30, 2025· FDA

FDA approved supplemental application for Zepzelca (lurbinectedin) — Labeling (NDA 213702 S-10)

Sponsor: JAZZ. Class: Labeling.

Trial startedApr 4, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06801834

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Primary completionMar 31, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT06501976

An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy

Results postedFeb 28, 2025· ClinicalTrials.gov

Trial results posted: NCT05126433

Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

Trial registeredJan 30, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06801834

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Primary completionJan 29, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05740566

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

2024

Trial registeredNov 8, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06681220

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

Trial startedOct 31, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06217536

Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas

Trial startedSep 14, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06496048

Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC

Trial startedAug 31, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06497530

Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC

Trial startedJul 31, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06501976

An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy

Primary completionJul 29, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05091567

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With

Trial registeredJul 15, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06501976

An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy

Trial registeredJul 11, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06496048

Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC

Trial registeredJul 11, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06497530

Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC

Trial startedJun 13, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06228066

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

Primary completionMay 31, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05572476

Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer

Trial startedMay 31, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06385548

Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer

Trial startedMay 21, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06203210

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

Primary completionMay 1, 2024· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06385548

Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer

Trial registeredApr 26, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06385548

Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer

Trial registeredJan 29, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06228066

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

Trial registeredJan 22, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06217536

Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas

Trial registeredJan 12, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06203210

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

2023

Primary completionDec 20, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT05126433

Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

Primary completionNov 4, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT04638491

Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients

Trial startedOct 31, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05572476

Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer

Trial registeredOct 18, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06088290

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leio

Primary completionSep 30, 2023· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04358237

Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer.

Trial startedSep 21, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT06088290

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leio

FDA approval (supplemental)Jul 28, 2023· FDA

FDA approved supplemental application for Zepzelca (lurbinectedin) — Labeling (NDA 213702 S-8)

Sponsor: JAZZ. Class: Labeling.

Trial startedJul 27, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05918640

Lurbinectedin in FET-Fused Tumors

Trial startedJul 12, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05636111

Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer

Trial registeredJun 26, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05918640

Lurbinectedin in FET-Fused Tumors

Trial startedJun 7, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05876715

LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma

Trial startedMay 31, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05740566

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Trial registeredMay 25, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05876715

LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma

Trial startedMay 23, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05734066

Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma

Trial startedMay 8, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05574504

Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy

Trial registeredApr 5, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05800587

Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer

Primary completionMar 24, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT04610658

Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC

Trial registeredFeb 23, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05740566

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Trial startedFeb 22, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05800587

Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer

Trial registeredFeb 17, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05734066

Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma

2022

Primary completionDec 15, 2022· ClinicalTrials.gov

Primary completion: NCT05285033

RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

Trial registeredDec 5, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05636111

Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer

Trial registeredOct 13, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05578326

Study of Trilaciclib and Lurbinectidin

Trial startedOct 12, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05578326

Study of Trilaciclib and Lurbinectidin

Trial registeredOct 10, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05574504

Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy

Trial registeredOct 7, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05572476

Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer

Primary completionAug 30, 2022· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05042934

Lurbinectedin With or Without Irinotecan in Treating Patients With Relapsed or High Risk Metastatic Ewing Sarcoma

Trial startedJul 27, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05244239

Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer

Trial startedJul 22, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05153239

Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed S

Trial startedJun 14, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05229588

Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations

Primary completionApr 21, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05063318

Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors

FDA approval (supplemental)Apr 1, 2022· FDA

FDA approved supplemental application for Zepzelca (lurbinectedin) — Labeling (NDA 213702 S-4)

Sponsor: JAZZ. Class: Labeling.

Trial startedApr 1, 2022· ClinicalTrials.gov

Trial started: NCT05285033

RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

Trial registeredMar 17, 2022· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05285033

RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

Trial startedMar 3, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05126433

Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

Trial registeredFeb 17, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05244239

Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer

Trial registeredFeb 8, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05229588

Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations

Trial startedFeb 4, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05099666

Lurbinectedin + Doxorubicin In Leiomyosarcoma

Primary completionJan 18, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05072106

Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors

2021

Trial registeredDec 10, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05153239

Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed S

Results postedNov 22, 2021· ClinicalTrials.gov

Trial results posted: NCT02454972

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Trial registeredNov 19, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05126433

Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

Trial startedNov 18, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT05091567

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With

Trial registeredNov 1, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05101265

Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment

Trial registeredOct 29, 2021· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05099666

Lurbinectedin + Doxorubicin In Leiomyosarcoma

Results postedOct 28, 2021· ClinicalTrials.gov

Trial results posted: NCT02566993

Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

Trial registeredOct 25, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05091567

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With

Trial registeredOct 8, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05072106

Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors

Trial registeredOct 1, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05063318

Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors

Trial startedSep 15, 2021· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05042934

Lurbinectedin With or Without Irinotecan in Treating Patients With Relapsed or High Risk Metastatic Ewing Sarcoma

Trial registeredSep 13, 2021· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05042934

Lurbinectedin With or Without Irinotecan in Treating Patients With Relapsed or High Risk Metastatic Ewing Sarcoma

Trial startedJun 28, 2021· ClinicalTrials.gov

Trial started: NCT04894591

To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)

Primary completionJun 11, 2021· ClinicalTrials.gov

Phase 2 primary completion: NCT03213301

Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.

Trial startedJun 1, 2021· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04802174

Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers

Trial registeredMay 20, 2021· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT04894591

To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)

Trial registeredMar 17, 2021· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04802174

Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers

Trial startedMar 9, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT05101265

Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment

Trial startedJan 14, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT05072106

Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors

2020

Trial startedDec 4, 2020· ClinicalTrials.gov

Phase 2 trial started: NCT04607954

Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer

Trial startedNov 24, 2020· ClinicalTrials.gov

Phase 1 trial started: NCT04638491

Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients

Trial startedNov 23, 2020· ClinicalTrials.gov

Phase 1 trial started: NCT04610658

Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC

Trial registeredNov 20, 2020· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04638491

Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients

Trial registeredOct 30, 2020· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04610658

Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC

Trial registeredOct 29, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04607954

Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer

Trial startedOct 7, 2020· ClinicalTrials.gov

Phase 1 trial started: NCT05063318

Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors

Trial startedSep 21, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04358237

Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer.

Primary completionSep 18, 2020· ClinicalTrials.gov

Phase 2 primary completion: NCT02454972

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

FDA approvalJun 15, 2020· FDA

FDA approved Zepzelca (lurbinectedin) (NDA 213702)

Sponsor: JAZZ. Class: Type 1 - New Molecular Entity.

Trial registeredApr 24, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04358237

Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer.

Results postedMar 9, 2020· ClinicalTrials.gov

Trial results posted: NCT01970540

Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors

Results postedMar 5, 2020· ClinicalTrials.gov

Trial results posted: NCT02421588

Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients

Trial registeredMar 2, 2020· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT04291937

A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA

Primary completionFeb 24, 2020· ClinicalTrials.gov

Phase 3 primary completion: NCT02566993

Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

2019

Results postedSep 24, 2019· ClinicalTrials.gov

Trial results posted: NCT01951157

A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second

Results postedFeb 18, 2019· ClinicalTrials.gov

Trial results posted: NCT02451007

Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors

2018

Primary completionOct 12, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT02421588

Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients

2017

Trial startedSep 28, 2017· ClinicalTrials.gov

Phase 2 trial started: NCT03213301

Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.

Primary completionAug 9, 2017· ClinicalTrials.gov

Phase 1 primary completion: NCT01970540

Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors

Trial registeredJul 11, 2017· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03213301

Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.

Primary completionJan 5, 2017· ClinicalTrials.gov

Phase 1 primary completion: NCT01980667

Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors

2016

Primary completionNov 30, 2016· ClinicalTrials.gov

Phase 2 primary completion: NCT01951157

A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second

Primary completionOct 31, 2016· ClinicalTrials.gov

Phase 1 primary completion: NCT02210364

Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or

Trial startedAug 30, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02566993

Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

Primary completionAug 19, 2016· ClinicalTrials.gov

Phase 2 primary completion: NCT02451007

Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors

Trial startedMay 6, 2016· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT02611024

Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors

2015

Trial registeredNov 20, 2015· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT02611024

Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors

Trial registeredOct 2, 2015· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02566993

Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

Trial startedAug 25, 2015· ClinicalTrials.gov

Phase 2 trial started: NCT02454972

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Trial startedAug 12, 2015· ClinicalTrials.gov

Phase 2 trial started: NCT02451007

Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors

Trial startedMay 31, 2015· ClinicalTrials.gov

Phase 3 trial started: NCT02421588

Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients

Trial registeredMay 27, 2015· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT02454972

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Trial registeredMay 21, 2015· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT02451007

Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors

Trial registeredApr 20, 2015· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02421588

Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients

2014

Trial registeredAug 6, 2014· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT02210364

Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or

Trial startedJul 30, 2014· ClinicalTrials.gov

Phase 1 trial started: NCT01980667

Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors

2013

Trial registeredNov 11, 2013· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT01980667

Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors

Primary completionOct 31, 2013· ClinicalTrials.gov

Phase 1 primary completion: NCT01970553

Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors

Trial registeredOct 28, 2013· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT01970540

Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors

Trial registeredOct 28, 2013· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT01970553

Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors

Trial registeredSep 26, 2013· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT01951157

A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second

Trial startedSep 11, 2013· ClinicalTrials.gov

Phase 2 trial started: NCT01951157

A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second

Trial startedApr 30, 2013· ClinicalTrials.gov

Phase 1 trial started: NCT02210364

Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or

2011

Trial startedMay 31, 2011· ClinicalTrials.gov

Phase 1 trial started: NCT01970553

Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors

Trial startedMay 25, 2011· ClinicalTrials.gov

Phase 1 trial started: NCT01970540

Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.