Sotorasib History and Updates

173 events · 2018 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 18, 2026.

FDA Approvals

Label Revisions

166

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-18Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Sotorasib since 2018, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (4)

2026

Results postedTrial results posted: NCT05054725· Jan 6, 2026

2025

Results postedSotorasib Combination Therapy Shows No Objective Response in NSCLC Trial· Dec 16, 2025
Primary completionSotorasib + Panitumumab Phase 3 Trial for KRAS G12C CRC Completes Primary· Jul 16, 2025
Results postedSotorasib Combination Trial for KRAS G12C NSCLC Terminated· May 1, 2025

Upcoming & expected milestones

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05074810

Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients

Trial startedAug 7, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07012031

Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a

Primary completionAug 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06582771

A Study of Sotorasib in People With Non-Small Cell Lung Cancer

Primary completionSep 5, 2026· ClinicalTrials.gov

Primary completion: NCT06532149

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Primary completionSep 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06068153

AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC

Primary completionOct 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT06333951

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Pr

Primary completionNov 24, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT06249282

Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Ca

Primary completionDec 17, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT04185883

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT04625647

Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment

Primary completionJun 14, 2027· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07012031

Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a

Primary completionJun 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05920356

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Parti

Primary completionAug 1, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT06804824

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors

Primary completionAug 31, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT05815173

Ladarixin With Sotorasib in Advanced NSCLC

Primary completionSep 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06497556

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-posi

Primary completionNov 14, 2027· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT07318389

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

Primary completionDec 12, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT05631249

Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT05398094

Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy

Primary completionJan 2, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07172919

A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation

Primary completionJan 31, 2028· ClinicalTrials.gov

Phase 1 primary completion: NCT06807619

A Study of Sotorasib in People With Brain Tumors

Primary completionJan 31, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT06252649

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic

Primary completionSep 25, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT06252649

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic

Primary completionOct 27, 2028· ClinicalTrials.gov

Phase 1 primary completion: NCT06333951

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Pr

Primary completionDec 31, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT05638295

Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatm

Primary completionJun 1, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT07543172

CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer

Primary completionSep 30, 2029· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07563738

A 2-part Phase 1/2 Open-label Trial on ODM-212

Primary completionJun 30, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT07124884

5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doubl

Primary completionJul 1, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT05564377

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening T

Primary completionAug 8, 2030· ClinicalTrials.gov

Phase 1 primary completion: NCT06892054

Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma

Past events

2026

Trial startedJun 10, 2026· ClinicalTrials.gov

EARLY_Phase 1 trial started: NCT07318389

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

Trial startedJun 1, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07543172

CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer

Primary completionMay 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05845450

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

Primary completionMay 30, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT03600883

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specifi

Trial registeredMay 4, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07563738

A 2-part Phase 1/2 Open-label Trial on ODM-212

Trial registeredApr 21, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07543172

CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer

Primary completionMar 30, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT04892017

Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors

Trial startedMar 27, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07563738

A 2-part Phase 1/2 Open-label Trial on ODM-212

Primary completionJan 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05451056

An Open-label, Phase 2trial of Sotorasib in KRAS G12C-mutant Non-small-cell Lung Cancer(NSCLC) Patients and a Translational Study to Find Ac

Primary completionJan 27, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06333678

A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)

Trial registeredJan 6, 2026· ClinicalTrials.gov

EARLY_Phase 1 trial registered on ClinicalTrials.gov: NCT07318389

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

Results postedJan 6, 2026· ClinicalTrials.gov

Trial results posted: NCT05054725

Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

Trial startedJan 2, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07172919

A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation

2025

Results postedDec 16, 2025· ClinicalTrials.gov

Trial results posted: NCT05313009

Tarlox and Sotorasib in Patients With KRAS G12C Mutations

Primary completionDec 7, 2025· ClinicalTrials.gov

Primary completion: NCT07143513

Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients

Trial registeredSep 15, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07172919

A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation

Trial startedAug 31, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07124884

5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doubl

Trial registeredAug 27, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07143513

Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients

Trial registeredAug 15, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07124884

5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doubl

Trial startedAug 11, 2025· ClinicalTrials.gov

Trial started: NCT07143513

Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients

Trial startedAug 8, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06892054

Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma

Primary completionJul 16, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05198934

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

Trial registeredJun 10, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07012031

Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a

Primary completionMay 27, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT04933695

A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatmen

Results postedMay 1, 2025· ClinicalTrials.gov

Trial results posted: NCT05374538

VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer

Primary completionApr 30, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05815186

Ladarixin With Sotorasib in Advanced NSCLC - Phase II

Trial startedMar 31, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06068153

AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC

Trial registeredMar 24, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06892054

Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma

Trial startedFeb 25, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06804824

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors

Trial registeredFeb 4, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06807619

A Study of Sotorasib in People With Brain Tumors

Trial registeredFeb 3, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06804824

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors

Trial startedJan 29, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06807619

A Study of Sotorasib in People With Brain Tumors

FDA approval (supplemental)Jan 16, 2025· FDA

FDA approved supplemental application for Lumakras (sotorasib) — Efficacy (NDA 214665 S-9)

Sponsor: AMGEN INC. Class: Efficacy.

2024

Primary completionDec 31, 2024· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04092673

Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Primary completionOct 1, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05311709

Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities

FDA approval (supplemental)Sep 30, 2024· FDA

FDA approved supplemental application for Lumakras (sotorasib) — Labeling (NDA 214665 S-12)

Sponsor: AMGEN INC. Class: Labeling.

Trial startedSep 23, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06497556

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-posi

Trial startedSep 17, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06333951

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Pr

Primary completionSep 9, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT06061523

A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants

Trial registeredSep 3, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06582771

A Study of Sotorasib in People With Non-Small Cell Lung Cancer

Trial startedAug 30, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06582771

A Study of Sotorasib in People With Non-Small Cell Lung Cancer

Primary completionAug 22, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT05480865

SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation

Trial startedAug 5, 2024· ClinicalTrials.gov

Trial started: NCT06532149

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Trial startedAug 1, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT05638295

Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatm

Trial registeredAug 1, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06532149

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Trial startedJul 17, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06252649

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic

Trial startedJul 15, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06061523

A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants

Trial registeredJul 11, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06497556

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-posi

Primary completionJul 3, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05054725

Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

Trial startedApr 30, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT05815186

Ladarixin With Sotorasib in Advanced NSCLC - Phase II

Trial startedApr 24, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06249282

Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Ca

Results postedApr 19, 2024· ClinicalTrials.gov

Trial results posted: NCT04887064

Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment

Trial registeredMar 27, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06333678

A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)

Trial registeredMar 27, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06333951

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Pr

Primary completionMar 21, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT06314763

Rivaroxaban Sotorasib Interaction Study

Trial startedMar 20, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06333678

A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)

Trial registeredMar 18, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06314763

Rivaroxaban Sotorasib Interaction Study

Trial registeredFeb 12, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06252649

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic

Trial registeredFeb 8, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06249282

Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Ca

Results postedJan 19, 2024· ClinicalTrials.gov

Trial results posted: NCT05497557

A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunte

Primary completionJan 1, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05400577

Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC

2023

Primary completionDec 19, 2023· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04720976

JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

Results postedDec 14, 2023· ClinicalTrials.gov

Trial results posted: NCT05327491

A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

Trial startedNov 16, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05920356

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Parti

Trial startedNov 9, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT06314763

Rivaroxaban Sotorasib Interaction Study

Trial registeredOct 5, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06068153

AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC

Trial registeredSep 29, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06061523

A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants

Results postedSep 18, 2023· ClinicalTrials.gov

Trial results posted: NCT05048784

A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

Primary completionSep 4, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT05993455

A Phase 2 Basket Trial in Which Patients With Advanced Solid Tumors Carrying the KRAS G12C mUtation Receive Treatment With a Combination of

Primary completionAug 26, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05374538

VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer

Trial registeredAug 15, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05993455

A Phase 2 Basket Trial in Which Patients With Advanced Solid Tumors Carrying the KRAS G12C mUtation Receive Treatment With a Combination of

Results postedAug 14, 2023· ClinicalTrials.gov

Trial results posted: NCT05045638

Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Trial startedAug 1, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05815173

Ladarixin With Sotorasib in Advanced NSCLC

Primary completionJul 7, 2023· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05313009

Tarlox and Sotorasib in Patients With KRAS G12C Mutations

Trial startedJul 3, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05993455

A Phase 2 Basket Trial in Which Patients With Advanced Solid Tumors Carrying the KRAS G12C mUtation Receive Treatment With a Combination of

Trial registeredJun 27, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05920356

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Parti

Trial startedMay 11, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05845450

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

Trial registeredMay 6, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05845450

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

Primary completionApr 27, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT04959981

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC

FDA approval (supplemental)Apr 24, 2023· FDA

FDA approved supplemental application for Lumakras (sotorasib) — Labeling (NDA 214665 S-4)

Sponsor: AMGEN INC. Class: Labeling.

Trial registeredApr 18, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05815173

Ladarixin With Sotorasib in Advanced NSCLC

Trial registeredApr 18, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05815186

Ladarixin With Sotorasib in Advanced NSCLC - Phase II

Trial startedApr 7, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05564377

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening T

FDA approval (supplemental)Mar 17, 2023· FDA

FDA approved supplemental application for Lumakras (sotorasib) — Labeling (NDA 214665 S-7)

Sponsor: AMGEN INC. Class: Labeling.

Primary completionJan 31, 2023· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05251038

Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer

FDA approval (supplemental)Jan 20, 2023· FDA

FDA approved supplemental application for Lumakras (sotorasib) — Labeling (NDA 214665 S-3)

Sponsor: AMGEN INC. Class: Labeling.

2022

Trial startedDec 13, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05631249

Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

Trial registeredDec 6, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05638295

Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatm

Trial registeredNov 30, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05631249

Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

FDA approval (supplemental)Nov 21, 2022· FDA

FDA approved supplemental application for Lumakras (sotorasib) — Labeling (NDA 214665 S-2)

Sponsor: AMGEN INC. Class: Labeling.

Trial startedNov 9, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05374538

VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer

Trial registeredOct 3, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05564377

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening T

Trial startedSep 13, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05251038

Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer

Primary completionSep 8, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05497557

A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunte

Trial registeredAug 11, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05497557

A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunte

Trial startedAug 1, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05451056

An Open-label, Phase 2trial of Sotorasib in KRAS G12C-mutant Non-small-cell Lung Cancer(NSCLC) Patients and a Translational Study to Find Ac

Trial registeredJul 29, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05480865

SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation

Primary completionJul 17, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05327491

A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

Trial startedJul 14, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05497557

A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunte

Trial startedJul 13, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05400577

Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC

Trial registeredJul 11, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05451056

An Open-label, Phase 2trial of Sotorasib in KRAS G12C-mutant Non-small-cell Lung Cancer(NSCLC) Patients and a Translational Study to Find Ac

Trial startedJul 6, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05480865

SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation

Trial registeredJun 1, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05400577

Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC

Trial registeredMay 31, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05398094

Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy

Trial startedMay 30, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05311709

Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities

Trial registeredMay 16, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05374538

VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer

Trial startedApr 19, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05198934

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

Trial registeredApr 14, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05327491

A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

Trial startedApr 12, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05074810

Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients

Trial registeredApr 6, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05313009

Tarlox and Sotorasib in Patients With KRAS G12C Mutations

Trial registeredApr 5, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05311709

Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities

Trial startedMar 21, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05327491

A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

Trial startedMar 21, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05398094

Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy

Primary completionMar 9, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT04887064

Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment

Trial startedMar 7, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05313009

Tarlox and Sotorasib in Patients With KRAS G12C Mutations

Trial registeredFeb 22, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05251038

Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer

Primary completionFeb 18, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05048784

A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

Trial startedJan 28, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT04933695

A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatmen

Trial registeredJan 20, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05198934

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

2021

Trial startedDec 30, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT05054725

Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

Trial registeredOct 12, 2021· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05074810

Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients

Primary completionOct 10, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT05045638

Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Trial registeredSep 23, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05054725

Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

Trial registeredSep 17, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05048784

A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

Trial registeredSep 16, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05045638

Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Trial startedSep 2, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04959981

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC

Trial startedAug 20, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT05045638

Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Trial startedAug 16, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT05048784

A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

Trial registeredJul 13, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04959981

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC

Trial registeredJun 22, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04933695

A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatmen

Trial startedJun 15, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04892017

Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors

FDA approvalMay 28, 2021· FDA

FDA approved Lumakras (sotorasib) (NDA 214665)

Sponsor: AMGEN INC. Class: Type 1 - New Molecular Entity.

Trial registeredMay 19, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04892017

Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors

Trial registeredMay 14, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04887064

Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment

Trial startedApr 22, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04887064

Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment

Trial startedApr 16, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04625647

Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment

Trial startedMar 23, 2021· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04720976

JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

Trial registeredJan 22, 2021· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04720976

JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

2020

Trial registeredNov 12, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04625647

Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment

2019

Trial startedDec 17, 2019· ClinicalTrials.gov

Phase 1 trial started: NCT04185883

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Trial registeredDec 4, 2019· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04185883

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Trial startedOct 25, 2019· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04092673

Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Trial registeredSep 17, 2019· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04092673

Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

2018

Trial startedAug 27, 2018· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT03600883

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specifi

Trial registeredJul 26, 2018· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT03600883

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specifi

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.