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)

NCT07739199 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-B01D1-312
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Squamous Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Phase II: Investigator-assessed 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

Secondary Outcomes (15)

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

  Up to approximately 24 months

• Phase II/III: Progression-free Survival (PFS)

  Up to approximately 24 months

• Phase II/III: Objective Response Rate (ORR)

  Up to approximately 24 months

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

  Up to approximately 24 months

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

  Up to approximately 24 months

Study Arms (2)

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

Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody

ACTIVE 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.

Drug: PD-1/VEGF bispecific antibody; Drug: Paclitaxel; Drug: Carboplatin

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; Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody

Paclitaxel DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody

Carboplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody

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 or metastatic squamous non-small cell lung cancer;
• Agree to provide tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic disease;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Toxicities from prior anti-tumor therapy must 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 specified requirements;
• Urinary protein ≤1+ or \<1000 mg/24h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test excluding pregnancy, and patients must be non-lactating; all enrolled patients (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.

You may not qualify if:

• 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;
• Prior treatment with ADC drugs that use topoisomerase I inhibitors as the toxin, among others;
• Receipt of radical radiotherapy, major surgery, or large-field radiotherapy within 4 weeks before study randomization;
• History of severe heart disease or cerebrovascular disease;
• Receipt of long-term systemic corticosteroid therapy (e.g., prednisone \>10 mg/day) before the first dose;
• Active autoimmune diseases and inflammatory diseases requiring systemic treatment within 2 years;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Prolonged QTc interval, complete left bundle branch block, among others;
• Diagnosis of active malignancy within 3 years before study randomization;
• Hypertension inadequately controlled by two antihypertensive medications;
• Patients with poorly controlled blood glucose levels;
• History of ILD requiring steroid therapy, current ILD, or grade ≥2 radiation pneumonitis, among others;

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

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

MeSH Terms

Interventions

Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

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: 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)