Calderasib
Merck & Co., Inc. MRK · Non-small Cell Lung Cancer; Colon Adenocarcinoma; Rectal Adenocarcinoma
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
5
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Merck & Co., Inc. MRK Source: Company record for Merck & Co., Inc. (opens in a new tab)
- Indications
- Non-small Cell Lung Cancer; Colon Adenocarcinoma; Rectal Adenocarcinoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 24 May 20245 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Calderasib. Editors add each one with its source.
Filed application
No filed application is on record for Calderasib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Calderasib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07554339ClinicalTrials.gov record for NCT07554339 (opens in a new tab) | A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) | Phase 3 | Recruiting | 310 (estimated) | 15 Dec 2032 (estimated) | No |
| NCT07431827ClinicalTrials.gov record for NCT07431827 (opens in a new tab)KANDLELIT-013 | MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) | Phase 3 | Recruiting | 400 (estimated) | 26 Oct 2039 (estimated) | No |
| NCT07190248ClinicalTrials.gov record for NCT07190248 (opens in a new tab) | A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) | Phase 3 | Recruiting | 675 (estimated) | 7 Dec 2029 (estimated) | No |
| NCT06997497ClinicalTrials.gov record for NCT06997497 (opens in a new tab) | A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) | Phase 3 | Recruiting | 477 (estimated) | 28 Mar 2029 (estimated) | No |
| NCT06345729ClinicalTrials.gov record for NCT06345729 (opens in a new tab) | A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004) | Phase 3 | Recruiting | 348 (estimated) | 24 Jan 2028 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Calderasib.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT07431827 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07554339 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07190248 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06997497 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06345729 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.