A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer(PANKU-Lung01)

NCT06382116 | Active Not Recruiting Phase 3

• 1 other identifier: BL-B01D1-301
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

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

  Up to approximately 24 months

Secondary Outcomes (6)

• Overall survival (OS)

  Up to approximately 24 months

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (2)

BL-B01D1

EXPERIMENTAL

Participants receive BL-B01D1 as intravenous infusion for 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

Pemetrexed+Cisplatin or Carboplatin

EXPERIMENTAL

Participants receive Pemetrexed +Cisplatin or Carboplatin 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: Pemetrexed+Cisplatin or 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

Pemetrexed+Cisplatin or Carboplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Pemetrexed+Cisplatin or Carboplatin

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 and follow the requirements of the protocol;
• Age ≥18 years old;
• Expected survival time ≥3 months;
• Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer;
• Documented classical EGFR mutations detected from tumor tissue or blood samples;
• Had not received any systemic therapy other than EGFR-TKIs;
• Radiographic disease progression documented during or after third-generation EGFR-TKI therapy for metastatic or locally advanced disease;
• Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
• Must have at least one measurable lesion according to RECIST v1.1 definition;
• ECOG score 0 or 1;
• Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• The level of organ function must meet the requirements on the premise that blood transfusion is not allowed within 14 days before the screening period and no cell growth factor drugs are allowed;
• Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN;
• Urine protein ≤2+ or \< 1000mg/24h;

You may not qualify if:

• The patient has histologic or cytologic evidence of small cell or mixed small/non-small cell component or squamous non-small cell lung cancer;
• Chemotherapy, biological therapy, immunotherapy, etc., have been used within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy has been used within 5 days, palliative radiotherapy or anti-tumor therapy has been used within 2 weeks;
• Previous treatment with: a. an ADC with TOPI inhibitor as toxin; b. any systemic therapy in the context of metastatic/locally advanced disease;
• The history of severe cardiovascular and cerebrovascular diseases in the past six months prior screening;
• Thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis more than 4 weeks later was excluded;
• Complete left bundle branch block, III degree atrioventricular block, frequent and uncontrolled severe arrhythmia;
• Other malignancies diagnosed within 3 years before randomization;
• Hypertension poorly controlled by two antihypertensive drugs;
• History of interstitial lung disease (ILD) requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
• Patients with poor glycemic control;
• Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
• Patients with active central nervous system (CNS) metastases;
• Severe infection within 4 weeks before randomization; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;
• Patients with massive or symptomatic effusions or poorly controlled effusions;
• Imaging examination showed that the tumor had invaded or wrapped the abdomen, chest, neck, and large blood vessels;

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Li Zhang, PHD

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 22, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)