Recruiting
Phase 3

Calderasib & Durvalumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07554339

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Calderasib

Durvalumab

Placebo to MK-1084

Study Details

Brief summary:

Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.

The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT07554339

Start date

Jun 18, 2026

Status verified date

Sep, 2026

Completion date

Aug 17, 2037

Anticipated

Primary completion date

Dec 15, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.
  • Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.
  • Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.
  • Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.
  • If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).
  • If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy.
  • If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
  • Has a body weight ≥35 kg.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.
  • Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Has received prior treatment (other than definitive CCRT) for NSCLC.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids.
  • Has an active infection requiring systemic therapy.
  • Has a history of stem cell/solid organ transplant.
  • Has not adequately recovered from major surgery or has ongoing surgical complications.

Study Design

Enrollment

310 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Calderasib + Durvalumab

Participants will receive calderasib and durvalumab.

active comparator: Placebo + Durvalumab

Participants will receive placebo to calderasib and durvalumab.

Interventions

Calderasib

Tablet for oral administration.

Durvalumab

Solution for intravenous (IV) infusion.

Placebo to MK-1084

Placebo to MK-1084.

Primary outcome measure

  • Progression-Free Survival (PFS) [ Time Frame: Up to approximately 6 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Duly Healthcare ( Site 0158)

Recruiting

Lisle, Illinois, United States, 60532

Contacts

Study Coordinator

630-545-7760

NHO Revive Research Institute LLC ( Site 0118)

Recruiting

Lincoln, Nebraska, United States, 68506

Contacts

Study Coordinator

402-484-4900

New York Oncology Hematology P.C ( Site 9000)

Recruiting

Albany, New York, United States, 12206

Contacts

Study Coordinator

518-489-0044

WakeMed Raleigh Campus ( Site 0144)

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Study Coordinator

919-350-2873

Virginia Cancer Specialists ( Site 0114)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

703-208-3110

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.