MK-2870 vs Chemotherapyin NSCLC with Genomic Alterations

JRCT ID: jRCT2031240108

Registered date:24/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Non-small Cell Lung Cancer
• Date of first enrollment: 14/06/2024
• Target sample size: 39
• Countries of recruitment: United States,Japan,Australia,Japan,China,Japan,Hong Kong,Japan,Malaysia,Japan,Philippines,Japan,South Korea,Japan,Taiwan,Japan,Thailand,Japan,Vietnam,Japan,Brazil,Japan,Chile,Japan,Mexico,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,Poland,Japan,Spain,Japan,Turkey,Japan,United Kingdom,Japan,Canada,Japan
• Study type: Interventional

Intervention(s)

Arm A: MK-2870 4 mg/kg q2w on Days 1, 15, and 29 of every 6-week cycle
Arm B: Either docetaxel 75 mg/m2 q3w or pemetrexed 500 mg/m2 q3w on Days 1 and 22 of every 6-week cycle

Outcome(s)

Primary Outcome

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

Secondary Outcome

-Objective Response (OR) 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
-Adverse events (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-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
-Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
-Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
-Measurable disease per RECIST 1.1 as assessed by the local site investigator.
-Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
-Participants who have 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 HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
-Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
-Have an ECOG performance status of 0 or 1 within 3 days before randomization.

Exclude criteria

-Has predominantly squamous cell histology NSCLC.
-Has mixed tumor(s) with small cell elements.
-Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
-Has Grade >=2 peripheral neuropathy.
-Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
-Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
-Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
-Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
-Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
-Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
-Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
-Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
-Received prior treatment with a topoisomerase I-containing ADC.
-Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
-Known additional malignancy that is progressing or has required active treatment within the past 3 years.
-Active infection requiring systemic therapy.
-History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
-Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication.
-HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
-Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

Related Information

• Primary Sponsor: Koh Yasuhiro
• Secondary ID(s): NCT06074588