A clinical study of MK-2870 and chemotherapy to treat lung cancer (MK-2870-009)

Phase 1

Recruiting

• Conditions: Therapeutic area: Diseases [C] - Neoplasms [C04]; on-small Cell Lung Cancer (NSCLC), EGFR-mutated; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864

• Registration Number: CTIS2023-504910-31-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-07
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC)., Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade <1 or baseline., 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., Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable., Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy., Life expectancy of at least 3 months.

Exclusion Criteria

Predominantly squamous cell histology NSCLC., Known active central nervous system metastases and/or carcinomatous meningitis., Active infection requiring systemic therapy., History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease., Concurrent active HBV and HCV infection., History of allogeneic tissue/solid organ transplant., Participants who have not adequately recovered from major surgery or have ongoing surgical complications., History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years., Grade >2 peripheral neuropathy., 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., Uncontrolled, or significant cardiovascular disease or cerebrovascular disease., 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., Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.To compare MK-2870 to platinum-based doublet chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR<br>2.To compare MK-2870 to platinum-based doublet chemotherapy with respect to OS;Secondary Objective: To compare MK-2870 to platinum-based doublet chemotherapy with respect to ORR per RECIST 1.1 as assessed by BICR, To evaluate the DOR of MK-2870 versus platinum-based doublet chemotherapy, To evaluate the mean change from baseline in global health status/QoL, dyspnea, cough, and chest pain for MK-2870 versus platinum-based doublet chemotherapy, To evaluate the time to deterioration in global health status/QoL, dyspnea, cough, and chest pain for MK-2870 versus platinum-based doublet chemotherapy, To evaluate the safety and tolerability of MK-2870;Primary end point(s): Progression-free survival (PFS), Overall survival (OS)