A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC

Sponsor
Biotheus Inc.
Study ID
NCT05756972
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PM8002 — DRUG
    IV infusion
  • Carboplatin — DRUG
    IV infusion
  • Pemetrexed — DRUG
    IV infusion

Study Details

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II study to evaluate the efficacy and safety of PM8002 in combination with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed to EGFR-TKI treatment.

Key Dates

Start date
Jun 26, 2023
Status verified
Mar 2025
Primary completion
Sep 13, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
64 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PM8002+Chemotherapy
    Subjects will be administered with PM8002 plus pemetrexed and carboplatin via intravenously (IV) Q3W for 4 cycles, followed by PM8002 and pemetrexed until progression or for a maximum of 2 years.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to approximately 2 years ]

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