Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC

Trial details

Who runs it

Checkpoint Therapeutics, Inc.

Trial code

NCT04786964

Record updated

2 April 2025

Original description

This is an efficacy and safety study of cosibelimab (CK-301) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned in a 2:1 ratio to receive cosibelimab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin).Read full original descriptionShow less

A Randomized, Open-Label, Phase 3 Study of Cosibelimab (CK-301) in Combination With Platinum+Pemetrexed Chemotherapy in Subjects With First-Line Metastatic Non-squamous Non-Small Cell Lung Cancer

This is an efficacy and safety study of cosibelimab (CK-301) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned in a 2:1 ratio to receive cosibelimab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin).

The primary hypothesis is that cosibelimab in combination with pemetrexed/platinum chemotherapy prolongs Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.

Inclusion: Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV non-squamous NSCLC; Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated; Has measurable disease; Has not received prior systemic treatment for their advanced/metastatic NSCLC; Can provide tumor tissue; Has a life expectancy of at least 3 months; Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status; Has adequate organ function; If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents; If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 180 days after the last dose of study medication and chemotherapeutic agents.

Exclusion: Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of study medication; Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab), c) Had major surgery (<3 weeks prior to first dose); Received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study medication; Completed palliative radiotherapy within 7 days of the first dose of study medication; Is expected to require any other form of antineoplastic therapy while on study; Received a live-virus vaccination within 30 days of planned start of study medication; Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb); Is on chronic systemic steroids; Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam); Had prior treatment with any other anti-programmed cell death-1 (PD-1), or PD-ligand 1 (PD-L1) or PD-L2 agent or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways; Is a known regular user of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol); Has had an allogeneic tissue/solid organ transplant; Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers; Has active autoimmune disease that has required systemic treatment in past 2 years; Has an active infection requiring therapy; Has known history of Human Immunodeficiency Virus (HIV); Has known active Hepatitis B or C; Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial; Has active or history of interstitial lung disease or a history of (non infectious) pneumonitis that required steroids or current pneumonitis; Any known uncontrolled or significant cardiovascular disease; Has predominantly squamous cell histology NSCLC; Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, peritoneal carcinomatosis; Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; Known sensitivity to any component of cisplatin, carboplatin or pemetrexed; Is unable or unwilling to take folic acid or vitamin B12 supplementation; Has symptomatic ascites or pleural effusion; Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.

ClinicalTrials.gov NCT04786964