Studieoverzicht

Study name: 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 (MK-1084-007/KANDLELIT-007)

Histology	NSCLC, only non-squamous
Tumor stage	Stage III - IV
NCT Id	NCT07190248
Host / recruiting site 1	Amphia	Enrollment	Planned
Host / recruiting site 2	UMC Groningen	Enrollment	Planned
Therapy line	First line (1L)
PD-L1 expression	Negative: <1%Low: 1 - 49%High: ≥50%
Design	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.
Intervention	DRUG: Calderasib Administered as an oral tablet BIOLOGICAL: Pembrolizumab (+) Berahyaluronidase alfa Administered as a SC injection DRUG: Pemetrexed Administered as an IV Infusion DRUG: Cisplatin Administered as an IV Infusion DRUG: Carboplatin Administered as an IV Infusion
Key outcome parameters	Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Key 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)
Key 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
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