MK-2870 versus Platinum and Pemetrexed in TKI-treated Advanced EGFRm NSCLC

JRCT ID: jRCT2071240041

Registered date:24/07/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Non-small Cell Lung Cancer
• Date of first enrollment: 31/08/2024
• Target sample size: 45
• Countries of recruitment: United States of America,Japan,Canada,Japan,Argentina,Japan,Colombia,Japan,Mexico,Japan,France,Japan,Italy,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,Turkiye,Japan,India,Japan,Malaysia,Japan,South Korea,Japan,Taiwan,Japan,Thailand,Japan,Vietnam,Japan,China,Japan
• Study type: Interventional

Intervention(s)

Arm A: MK-2870 4mg/kg every 2 weeks(q2w)
Arm B: Pemetrexed 500 mg/m2 every 3 weeks(q3w) + carboplatin AUC 5mg/mL/min q3w for 4 doses followed by pemetrexed 500 mg/m2 q3w

Outcome(s)

Primary Outcome

-Progression-Free Survival (PFS) per RECIST 1.1 as assessed by BICR in advanced nonsquamous NSCLC with EGFR mutations.
-Overall Survival (OS) in advanced nonsquamous NSCLC with EGFR mutations.

Secondary Outcome

-Objective Response Rate (ORR) per RECIST 1.1 based on BICR
-Duration of Response (DOR) per RECIST 1.1 based on BICR
-Change from baseline in EORTC QLQ-C30, EORTC QLQ-LC13
-AEs, Study intervention discontinuation due to AEs

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

-Predominantly squamous cell histology NSCLC.
-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.
-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.

Related Information

• Primary Sponsor: Fujita Tomoko
• Secondary ID(s): NCT06305754