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 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-B01D1-313
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (4)

• Phase II: Objective Response Rate (ORR)

  Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

  Up to approximately 24 months

• Phase II: Investigator-assessed Progression-free Survival (PFS)

  Investigator-assessed progression-free survival (PFS) per RECIST v1.1 is defined as the time from treatment initiation until the first documented disease progression according to RECIST v1.1 criteria, or death from any cause, whichever occurs first, as determined by the local treating investigator.

  Up to approximately 24 months

• Phase III: BICR-assessed Progression-free Survival (PFS)

  Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

  Up to approximately 24 months

• Phase III: Overall Survival (OS)

  Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.

  Up to approximately 24 months

Secondary Outcomes (13)

• Phase II/III: Disease Control Rate (DCR)

  Up to approximately 24 months

• Phase II/III: Duration of Response (DOR)

  Up to approximately 24 months

• Phase II/III: Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Phase III: Progression-free Survival (PFS)

  Up to approximately 24 months

• Phase III: BICR and Investigator-assessed Objective Response Rate (ORR)

  Up to approximately 24 months

Study Arms (3)

BL-B01D1 + PD-1/VEGF Bispecific Antibody

EXPERIMENTAL

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.

Drug: BL-B01D1; Drug: PD-1/VEGF Bispecific Antibody

PD-1/VEGF Bispecific Antibody + Pemetrexed + Carboplatin or Cisplatin

ACTIVE COMPARATOR

Participants receive PD-1/VEGF Bispecific Antibody + Pemetrexed + Carboplatin or Cisplatin 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.

Drug: PD-1/VEGF Bispecific Antibody; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

Tislelizumab + Pemetrexed + Carboplatin or Cisplatin

ACTIVE COMPARATOR

Participants receive Tislelizumab + Pemetrexed + Carboplatin or Cisplatin 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.

Drug: Tislelizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

BL-B01D1 + PD-1/VEGF Bispecific Antibody

PD-1/VEGF Bispecific Antibody DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-B01D1 + PD-1/VEGF Bispecific Antibody; PD-1/VEGF Bispecific Antibody + Pemetrexed + Carboplatin or Cisplatin

Tislelizumab DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Tislelizumab + Pemetrexed + Carboplatin or Cisplatin

Pemetrexed DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

PD-1/VEGF Bispecific Antibody + Pemetrexed + Carboplatin or Cisplatin; Tislelizumab + Pemetrexed + Carboplatin or Cisplatin

Carboplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

PD-1/VEGF Bispecific Antibody + Pemetrexed + Carboplatin or Cisplatin; Tislelizumab + Pemetrexed + Carboplatin or Cisplatin

Cisplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

PD-1/VEGF Bispecific Antibody + Pemetrexed + Carboplatin or Cisplatin; Tislelizumab + Pemetrexed + Carboplatin or Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Agree to provide tumor tissue samples obtained at or after diagnosis of locally advanced or metastatic cancer;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;
• Organ function levels must meet the required criteria;
• Urinary protein ≤ 2+ or \< 1000 mg/24h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy test must rule out pregnancy; patients must be non-lactating and must use highly effective contraceptive measures throughout the treatment period and for 7 months after the last dose. For male participants whose partners are women of childbearing potential, adequate barrier contraceptive measures must be used throughout the treatment period and for 7 months after the end of treatment.

You may not qualify if:

• 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;
• Prior receipt of antibody-drug conjugates (ADCs) using topoisomerase I inhibitors as the toxin, etc.;
• Trial participants who have received prior systemic anti-angiogenic therapy;
• Receipt of radical radiotherapy, major surgery, or large-field radiotherapy within 4 weeks before study randomization;
• History of severe cardiac or cerebrovascular disease;
• Receiving long-term systemic corticosteroid therapy (e.g., \>10 mg/day prednisone) prior to the first dose;
• Active autoimmune diseases and inflammatory diseases;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Prolonged QT interval, complete left bundle branch block, etc.;
• Diagnosis of active malignancy within 3 years before study randomization;
• Hypertension poorly controlled by two antihypertensive medications;
• Patients with poorly controlled blood glucose;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

tislelizumab; Pemetrexed; Carboplatin; Cisplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

CN (2)