A Study Evaluating BL-B01D1 in Combination With a PD-1/VEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer(PANKU-Lung06)

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

Disqualifiers

Presence of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma components, or squamous carcinoma components exceeding 10%;

Evidence suggesting the presence of EGFR-sensitive mutations, etc.;

Patients who have received prior systemic therapy;

Prior receipt of therapies targeting the mechanism of tumor immunity;

Trial design

Treatments tested in this trial

  • BL-B01D1
  • PD-1/VEGF Bispecific Antibody
  • Tislelizumab
  • Pemetrexed
  • Carboplatin
  • Cisplatin

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

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

Collaborator