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)

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This trial is a registrational Phase II/III randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in combination with PD-1/VEGF bispecific antibody in first-line patients with locally advanced or metastatic squamous non-small cell lung cancer.

Eligibility criteria

Qualifiers

Voluntarily sign the informed consent form and comply with the protocol requirements;

Age ≥18 years;

Expected survival time ≥3 months;

Patients with locally advanced or metastatic squamous non-small cell lung cancer;

Disqualifiers

Prior histological or cytological evidence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;

Indications of the presence of EGFR-sensitive mutations, among others;

Patients who have received prior systemic therapy;

Prior treatment with agents targeting the mechanism of tumor immune action;

Trial design

Treatments tested in this trial

  • BL-B01D1
  • PD-1/VEGF bispecific antibody
  • Paclitaxel
  • Carboplatin

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator