A clinical study to compare MK-2870 with pembrolizumab to pembrolizumab alone in people with lung cancer (MK-2870-007)
- Conditions
- Metastatic non-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503376-24-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 625
Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC), Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy, Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in =50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory, An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization, A life expectancy of at least 3 months, Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements, 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 are allowed., Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy, Known additional malignancy that is progressing or has required active treatment within the past 3 years, Known active central nervous system (CNS) metastases and/or carcinomatous meningitis, Known intolerance to MK-2870 or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (=Grade 3) is exclusionary, Known hypersensitivity to MK-2870 or other biologic therapy, Active autoimmune disease that has required systemic treatment in the past 2 years, History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, Active infection requiring systemic therapy, Has Grade =2 peripheral neuropathy, Concurrent active Hepatitis B and Hepatitis C virus infection, HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease, History of allogeneic tissue/solid organ transplant, Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study, History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing, Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea), Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention, Received prior systemic anticancer therapy for their metastatic NSCLC, Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC., Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, Received radiation therapy to the lung within 6 months of start of study intervention
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to PFS per RECIST 1.1 as assessed by BICR, To compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to ORR per RECIST 1.1 as assessed by BICR, To evaluate DOR per RECIST 1.1 as assessed by BICR of MK-2870 combined with pembrolizumab compared to pembrolizumab alone, To evaluate the mean change from baseline in global health status/quality of life (QoL), dyspnea, cough, and chest pain of MK-2870 combined with pembrolizumab compared to pembrolizumab alone, To evaluate the time to deterioration in global health status/QoL, dyspnea, cough, and chest pain of MK-2870 combined with pembrolizumab compared to pembrolizumab alone, To evaluate the safety and tolerability of MK-2870 combined with pembrolizumab;Primary end point(s): Overall Survival (OS);Main Objective: To compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to OS
- Secondary Outcome Measures
Name Time Method