A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT06954246
Phase
PHASE3
Status
Recruiting
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Conditions

  • Small Cell Lung Cancer Extensive Stage

Eligibility Criteria

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

Interventions

  • MHB088C for Injection — DRUG
    2 mg/kg intravenous dose on Day 1 and Day 15 of each 28-day cycle
  • Topotecan — DRUG
    1.25 mg/m\^2 intravenous dose on Day 1 to Day 5 of each 21-day cycle
  • Irinotecan — DRUG
    65 mg/m\^2 intravenous dose on Day 1 and Day 8 of each 21-day cycle
  • Paclitaxel — DRUG
    135 mg/m\^2 intravenous dose on Day 1 of each 21-day cycle

Study Details

This study was designed to compare the efficacy and safety of MHB088C for Injection with treatment of physician's choice (TPC) in participants with relapsed small cell lung cancer (SCLC).

Key Dates

Start date
Jun 4, 2025
Status verified
Apr 2025
Primary completion
May 31, 2027
Completion
Apr 30, 2028

Study Design

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

Arms

  • Experimental: MHB088C for Injection
    Participants randomized to receive 2 mg/kg MHB088C monotherapy on Day 1 and Day 15 of each 28-day cycle until unacceptable toxicity, progressive disease (PD), or withdrawal of consent as specified in the protocol.
  • Active Comparator: Treatment of Physician's Chioce (TPC)
    Participants randomized to receive topotecan, irinotecan, or paclitaxel, as per investigator's choice and per approved label (indicated dose and frequency), until a treatment discontinuation criterion is met as specified in the protocol.

Primary Outcome Measure

Overall Survival [ Time Frame: From the date of randomization to the date of death due to any cause, up to approximately 5 years ]

Central Contacts

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