Calderasib History and Updates

45 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
45
Trial Milestones
0
Pivotal Publications
Calderasib — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2022202320242025202620272028202920302031203220332034203520362037203820392040Trial: NCT07554339 2026-06-05 → 2032-12-15 (primary completion)Trial: NCT07431827 2026-03-18 → 2039-10-26 (primary completion)Trial: NCT07209111 2025-12-04 → 2032-04-09 (primary completion)Trial: NCT07222098 2025-11-19 → 2025-12-14 (primary completion)Trial: NCT07219550 2025-11-05 → 2026-08-07 (primary completion)Trial: NCT07190248 2025-10-08 → 2029-12-07 (primary completion)Trial: NCT06997497 2025-07-16 → 2029-03-28 (primary completion)Trial: NCT06942741 2025-05-13 → 2025-06-22 (primary completion)Trial: NCT06814119 2025-04-07 → 2026-01-23 (primary completion)Trial: NCT06575933 2024-09-03 → 2024-10-28 (primary completion)Trial: NCT06687759 2024-06-26 → 2024-08-07 (primary completion)Trial: NCT06345729 2024-05-24 → 2029-02-19 (primary completion)Trial: NCT06719557 2024-05-20 → 2024-07-30 (primary completion)Trial: NCT06619314 2023-09-20 → 2023-11-25 (primary completion)Trial: NCT05067283 2021-12-17 → 2030-02-25 (primary completion)today (2026-06-16)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-16Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Calderasib since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07219550
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06345729
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With P
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06997497
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07190248
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07554339
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

Past events

2026
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07554339
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07431827
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
2025
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07209111
A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07222098
A Clinical Study of Calderasib (MK-1084) With Rosuvastatin and Metformin in Healthy People (MK-1084-016)
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07219550
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07190248
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06997497
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06942741
A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011)
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06942741
A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011)
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06814119
A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010)
2024
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06575933
A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009)
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06687759
A Study of Calderasib (MK-1084) Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006)
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06719557
A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06687759
A Study of Calderasib (MK-1084) Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06345729
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With P
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06719557
A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)
2023
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06619314
A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on Calderasib (MK-1084) in Healthy Adult Participants
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06619314
A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on Calderasib (MK-1084) in Healthy Adult Participants
2021

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.