Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab (CK-301) in First Line Metastatic Non-squamous Non-Small Cell Lung Cancer (CONTERNO)

  • STATUS
    Recruiting
  • End date
    May 13, 2025
  • participants needed
    560
  • sponsor
    Checkpoint Therapeutics, Inc.
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Updated on 13 March 2022
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Summary

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.

Details
Condition Metastatic Non-squamous Non Small Cell Lung Cancer
Treatment cisplatin, carboplatin, Pemetrexed, Dexamethasone 4mg, Vitamin B12 1000 μg, Cosibelimab, Folic acid 350-1000 μg
Clinical Study IdentifierNCT04786964
SponsorCheckpoint Therapeutics, Inc.
Last Modified on13 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

Has predominantly squamous cell histology NSCLC
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
Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, peritoneal carcinomatosis
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 known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
Known sensitivity to any component of cisplatin, carboplatin or pemetrexed
Has active autoimmune disease that has required systemic treatment in past 2 years
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)
Is unable or unwilling to take folic acid or vitamin B12 supplementation
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
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
Is a known regular user of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)
Has symptomatic ascites or pleural effusion
Has active or history of interstitial lung disease or a history of (non infectious) pneumonitis that required steroids or current pneumonitis
Has had an allogeneic tissue/solid organ transplant
Any known uncontrolled or significant cardiovascular disease
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
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