What is calderasib studying for non-small cell lung cancer?

Calderasib is being studied to see if it can help people with a specific type of lung cancer live longer without their disease getting worse. The study compares calderasib combined with pembrolizumab to pembrolizumab with chemotherapy. This research is sponsored by Merck Sharp & Dohme LLC to better understand treatment options for this cancer type.

Who may be eligible for this non-small cell lung cancer clinical trial?

Adults aged 18 years or older with nonsquamous NSCLC at certain advanced stages may be eligible. The study includes people of any gender who have not had prior systemic treatment for their advanced cancer and do not have active brain metastases. Please review eligibility criteria for more details.

Is there any cost to participate in this non-small cell lung cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07190248

A Phase 3 Study of MK-1084 with Subcutaneous Pembrolizumab and Berahyaluronidase Alfa Versus Pembrolizumab with Chemotherapy for KRAS G12C-Mutant Advanced Nonsquamous NSCLC

Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08

675

Participants Needed

175

Research Sites

139 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying whether the medicines calderasib and subcutaneous pembrolizumab can be used together to treat non-small cell lung cancer NSCLC in people with a specific KRAS G12C mutation. The main goal is to find out if patients receiving calderasib plus pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. Participants will be randomly assigned to one of two groups one group will receive pembrolizumab and berahyaluronidase alfa as a subcutaneous injection every 6 weeks for up to about 2 years plus calderasib pills daily until treatment needs to stop. The other group will receive the same pembrolizumab and berahyaluronidase alfa injections plus chemotherapy drugs pemetrexed with either carboplatin or cisplatin delivered by intravenous infusion at specific days during the treatment cycles. Throughout the study, participants will be closely monitored for how long they live without cancer progression, overall survival, response to treatment, and quality of life using questionnaires and other assessments. The study will track side effects and any reasons for stopping treatment over several years, with evaluations continuing for up to about 81 months. This long-term follow-up helps researchers understand the safety and impact of these treatments over time.

CONDITIONS

Brief Title

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Has nonsquamous non-small cell lung cancer (NSCLC) at Stage IIIB, IIIC, or IV not eligible for curative surgery or chemoradiation
If HIV positive, must have well-controlled HIV on antiretroviral therapy
Adults aged 18 years or older

You will not qualify if you...

Has small cell lung cancer or mixed tumors with small cell elements
Has active inflammatory bowel disease requiring immunosuppressive medication or a history of inflammatory bowel disease
Has uncontrolled significant cardiovascular or cerebrovascular disease
Has a gastrointestinal disorder affecting drug absorption
HIV positive with history of Kaposi's sarcoma or Multicentric Castleman's Disease
Has received prior systemic anticancer therapy for advanced or metastatic NSCLC
Has another progressing malignancy requiring treatment within the past 3 years
Has active central nervous system metastases or carcinomatous meningitis
Has active autoimmune disease treated systemically in the past 2 years
History or current pneumonitis or interstitial lung disease requiring steroids
Has an active infection requiring systemic therapy (except as allowed by protocol)
History of stem cell or solid organ transplant
Not fully recovered from major surgery or has ongoing surgical complications

Research Team

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