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)
NCT07739186 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-07-31
Summary
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.
Conditions
- Non-squamous Non-small Cell Lung Cancer
Interventions
- DRUG
-
BL-B01D1
Administration by intravenous infusion for a cycle of 3 weeks.
- DRUG
-
PD-1/VEGF Bispecific Antibody
Administration by intravenous infusion for a cycle of 3 weeks.
- DRUG
-
Administration by intravenous infusion for a cycle of 3 weeks.
- DRUG
-
Pemetrexed
Administration by intravenous infusion for a cycle of 3 weeks.
- DRUG
-
Administration by intravenous infusion for a cycle of 3 weeks.
- DRUG
-
Administration by intravenous infusion for a cycle of 3 weeks.
Sponsors & Collaborators
-
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Sichuan Baili Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2029-12-31
- Completion
- 2029-12-31
Countries
- China
Study Locations
More Related Trials
-
A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)
NCT07582315 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC
NCT07178795 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors
NCT07232420 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer
NCT06437509 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of BL-B16D1 in Patients With Locally Advanced or Metastatic Solid Tumors
NCT06475131 ·Status: RECRUITING ·Phase: PHASE1
-
Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer
NCT03432598 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
NCT05142189 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
NCT05949619 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
NCT07279428 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors
NCT07056556 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
NCT06437522 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer
NCT06114511 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
NCT05470348 ·Status: RECRUITING ·Phase: PHASE1
-
Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine in Advanced Lung Cancer and Lung Metastasis of Solid Tumors.
NCT06928922 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
NCT06471205 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor
NCT05194982 ·Status: RECRUITING ·Phase: PHASE1
-
Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
NCT05983432 ·Status: RECRUITING ·Phase: PHASE1
-
Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Lung Cancer
NCT03501056 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors
NCT06349811 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
NCT05956587 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
NCT06493864 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
NCT05262491 ·Status: RECRUITING ·Phase: PHASE1
-
Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
NCT07021066 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer
NCT02793856 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer
NCT06978114 ·Status: RECRUITING ·Phase: PHASE2