Home › Trials › NCT07190248

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

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

PHASE3 · Merck Sharp & Dohme LLC · NCT07190248

This trial will test whether adding the KRAS G12C drug calderasib to subcutaneous pembrolizumab helps people with advanced nonsquamous non‑small cell lung cancer live longer without the cancer growing compared with pembrolizumab plus chemotherapy.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment675 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC (industry)
Drugs / interventionspembrolizumab, chemotherapy
Locations153 sites (Birmingham, Alabama and 152 other locations)
Trial IDNCT07190248 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with unresectable nonsquamous NSCLC (Stage IIIB/IIIC or Stage IV) whose tumors harbor a KRAS G12C mutation and who meet other health and treatment‑history criteria are the intended participants.

Not a fit: Patients with small cell lung cancer or mixed tumors containing small cell elements, active inflammatory bowel disease requiring immunosuppression, uncontrolled cardiovascular or gastrointestinal conditions, or other disqualifying prior treatments are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could extend progression‑free survival for patients with KRAS G12C NSCLC and might reduce or delay the need for conventional chemotherapy.

How similar studies have performed: Earlier-phase studies of KRAS G12C inhibitors and of PD‑1 immunotherapy have shown clinical activity, and combinations are promising but not yet proven in large randomized trials, so this phase 3 trial addresses that open question.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 152 other locations

+103 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.