PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer

Sponsor
Biotheus Inc.
Study ID
NCT06616532
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PM8002 — DRUG
    Following a predefined dose and date.
  • Paclitaxel — DRUG
    175mg/m2 via IV infusion on Day 1 Q3W
  • Topotecan — DRUG
    1.25mg/m2/day via IV infusion on Days 1-5 Q3W

Study Details

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel as second-line treatment for SCLC

Key Dates

Start date
Nov 13, 2024
Status verified
Apr 2026
Primary completion
Jan 25, 2027
Completion
Dec 25, 2028

Study Design

Enrollment
404 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PM8002+Paclitaxel
    Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion.
  • Active Comparator: Chemotherapy
    Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to approximately 32 months from first patient in ]

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