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NCT07739199

A Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)

StatusRecruiting
PhasePhase 2/3
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 200 → 326 participants
    • Eligibility criteria expanded, about 42 words
    • Start date changed from estimate of Aug 2026 to Oct 10, 2026
    • Interventions: BL-B01D1 (Drug), Carboplatin (Drug), PD-1/VEGF bispecific antibody (Drug), Paclitaxel (Drug) to BL-B01D1 (Drug), Carboplatin (Drug), PD-1/VEGF bispecific antibody (Drug), Paclitaxel (Drug)
    • Secondary endpoints: details revised at 14 of 15 entries
    • Site details revised at 2 of 2 sites
  2. Site contacts updated at 2 of 2 sitesv2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase II Part A: Treatment Emergent Adverse Event (TEAE)
Timeframe: Up to approximately 24 months
Phase II Part B: Investigator-assessed Objective Response Rate (ORR)
Timeframe: Up to approximately 24 months
Phase II Part B: Investigator-assessed Progression-free Survival (PFS)
Timeframe: Up to approximately 24 months
Phase III: BICR-assessed Progression-free Survival (PFS)
Timeframe: Up to approximately 24 months

Secondary (15)

Phase II/III:Treatment Emergent Adverse Event (TEAE)
Phase II/III: Progression-free Survival (PFS)
Phase II/III: Objective Response Rate (ORR)
Phase II/III: Disease Control Rate (DCR)
Phase II/III: Duration of Response (DOR)
Show 10 moreShow less
Phase II/III: Cmax
Phase II/III: Tmax
Phase II/III: T1/2
Phase II/III: AUC0-t
Phase II/III: CL (Clearance)
Phase II/III: Ctrough
Phase II/III: Anti-drug Antibody (ADA)
Phase II/III: Neutralizing Antibody(NAb)
Phase II: Drug-Drug Interaction (DDI)
Phase III: Overall Survival (OS)

Arms and interventions

BL-B01D1 + PD-1/VEGF bispecific antibodyExperimental

Participants receive BL-B01D1 + PD-1/VEGF bispecific antibody in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibodyActive comparator

Participants receive Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drugs: BL-B01D1, PD-1/VEGF bispecific antibody, Paclitaxel, Carboplatin

Sites

2 sites in 1 country