Pembrolizumab With or Without Maintenance MK-2870 in Metastatic Squamous NSCLC

Phase 1

Conditions: Participants with treatment-naïve metastatic squamous Non-small Cell Lung Cancer (NSCLC)
MedDRA version: 24.0Level: LLTClassification code: 10085300Term: Squamous non-small cell lung cancer Class: 100000004848
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-510128-66-00

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8)., Measurable disease per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by the local site investigator/radiology., Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to =Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible., Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)., Life expectancy of at least 3 months., Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 assessed within 7 days before allocation., Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation., Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative antiviral therapy at least 4 weeks before randomization., Participants without disease progression of their NSCLC, as determined by blinded independent central review (BICR) using RECIST 1.1 after completion of study-specified induction with an evaluable scan at Week 12 prior to randomization for maintenance.

Exclusion Criteria

Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements., Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC)., Received prior treatment with a topoisomerase I inhibitor-containing ADC., Received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation., Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention., Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids., Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed., Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration., Is currently receiving a strong and/or moderate inducer/inhibitor of Cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting MK-2870 is 2 weeks., 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., Grade =2 peripheral neuropathy., Severe hypersensitivity (=Grade 3) to study intervention and/or any of its excipients or to another biologic therapy., Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed., History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Active infection requiring systemic therapy., Concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV Ab positive and detectable HCV RNA) infection., History of allogeneic tissue/solid organ transplant., History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing., Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)., Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval by Fridericia (QTcF) interval to >480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention., HIV-infected participants who have been newly diagnosed or with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease., Received prior systemic anticancer therapy for their metastatic NSCLC., Participants who have not adequately recovered from major surgery or have ongoing surgical complications., Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor