NCT07190248 A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
| NCT ID | NCT07190248 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 675 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2029-12-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 675 participants in total. It began in 2025-10-08 with a primary completion date of 2029-12-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
Eligibility 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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07190248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07190248 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 675 participants.
Is NCT07190248 currently recruiting?
Yes, NCT07190248 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07190248 trial being conducted?
This trial is being conducted at Birmingham, United States, Beverly Hills, United States, Farmington, United States, Stamford, United States and 11 additional locations.
Who is sponsoring the NCT07190248 clinical trial?
NCT07190248 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 675 participants.
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