Calderasib plus durvalumab in KRAS G12C NSCLC after chemo-radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional study in locally advanced, unresected NSCLC with KRAS G12C mutation. Participants have completed platinum-based chemoradiotherapy and will receive calderasib with durvalumab or placebo with durvalumab to see if the cancer stays under control longer. The study uses central testing of tumor samples for KRAS G12C and PD-L1, along with biomarker research. If eligible, participants must have stable HIV on ART or managed HBV/HCV as applicable. Primary goals focus on progression-free survival and overall survival.

Why it matters

Who can join: the full rules

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.

Where it's running

• Low Country Cancer Care ( Site 0155)
  Savannah, Georgia, United States Recruiting
• Duly Healthcare ( Site 0158)
  Lisle, Illinois, United States Recruiting
• NHO Revive Research Institute LLC ( Site 0118)
  Lincoln, Nebraska, United States Recruiting
• Rutgers Cancer Institute of New Jersey ( Site 0100)
  New Brunswick, New Jersey, United States Recruiting
• New York Oncology Hematology P.C ( Site 9000)
  Albany, New York, United States Recruiting
• WakeMed Raleigh Campus ( Site 0144)
  Raleigh, North Carolina, United States Recruiting

+65 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.