Calderasib plus subcutaneous pembrolizumab for KRAS G12C non-small cell lung cancer

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, randomized study comparing calderasib combined with subcutaneous pembrolizumab versus subcutaneous pembrolizumab with standard platinum‑based chemotherapy (pemetrexed plus cisplatin or carboplatin) in patients with advanced nonsquamous NSCLC. Calderasib is a targeted therapy directed at the KRAS G12C mutation, and the pembrolizumab is given in a subcutaneous formulation with hyaluronidase. The main goal is to determine whether the calderasib combination prolongs the time patients live without disease progression compared with the chemotherapy arm. The trial is conducted at multiple U.S. centers and is sponsored by Merck Sharp & Dohme LLC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

* Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
* If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria:

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

* Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has a gastrointestinal disorder affecting absorption
* Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy except those specified by protocol
* Has history of stem cell/solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications

Where it's running

• Central Alabama Research ( Site 0108)
  Birmingham, Alabama, United States Recruiting
• Beverly Hills Cancer Center ( Site 0142)
  Beverly Hills, California, United States Recruiting
• University of Connecticut Health Center ( Site 0130)
  Farmington, Connecticut, United States Recruiting
• Stamford Hospital ( Site 0126)
  Stamford, Connecticut, United States Recruiting
• The Oncology Institute of Hope and Innovation ( Site 0161)
  Fort Lauderdale, Florida, United States Recruiting
• Low Country Cancer Care ( Site 0156)
  Savannah, Georgia, United States Recruiting

+175 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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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.