A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

Official title

A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

Overview

This trial is a registrational Phase II/III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in resectable EGFR-mutant non-small cell lung cancer.

Interventions

• Drug BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Drug Osimertinib
  Oral administration for a cycle of 3 weeks.
• Drug Carboplatin
  Administration by intravenous infusion for a cycle of 3 weeks.
• Drug Pemetrexed
  Administration by intravenous infusion for a cycle of 3 weeks.
• Drug Cisplatin
  Administration by intravenous infusion for a cycle of 3 weeks.

Primary outcome measures

• Major Pathological Response (MPR) [Time frame: Up to approximately 24 months]

Secondary outcome measures (5)

• Pathologic complete response (pCR) [Time frame: Up to approximately 24 months]
• Event-Free Survival (EFS) [Time frame: Up to approximately 24 months]
• Overall Survival (OS) [Time frame: Up to approximately 24 months]
• Treatment Emergent Adverse Event (TEAE) [Time frame: Up to approximately 24 months]
• Anti-drug antibody (ADA) [Time frame: Up to approximately 24 months]

Eligibility criteria

Inclusion criteria

• Voluntarily sign informed consent and agree to comply with the protocol requirements;
• Aged ≥18 years and ≤75 years, regardless of gender;
• Expected survival time ≥3 months;
• Patients with non-small cell lung cancer;
• One of the EGFR sensitive mutation types detected in the tumor tissue;
• Agree to provide archived primary tumor tissue specimens obtained within 12 months or fresh tissue samples;
• Undergo pulmonary function testing within 28 days prior to the first dose;
• ECOG performance status score of 0 or 1;
• No severe cardiac dysfunction;
• Organ function levels must meet the required criteria;
• Urine protein ≤1+ or <1000 mg/24h;
• For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be lactating; all enrolled trial participants must use adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.

Exclusion criteria

• SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;
• Trial participants who subsequently receive only segmentectomy or wedge resection;
• Trial participants deemed surgically inoperable by the study center's surgical evaluation;
• Undergoing major surgery within 4 weeks prior to the first dose, among others;
• Previous receipt of systemic anti-tumor therapy for non-small cell lung cancer other than that for this study, among others;
• Receiving long-term systemic corticosteroid therapy with prednisone >10 mg/day within 2 weeks prior to randomization, among others;
• History of severe heart disease or cerebrovascular disease;
• Prolonged QTc interval, complete left bundle branch block, etc.;
• Any thrombotic event within 6 months prior to screening;
• Trial participants with known or suspected interstitial lung disease, among others;
• Diagnosis of active malignant tumors within 5 years prior to study randomization;
• Hypertension inadequately controlled by two antihypertensive medications;
• Trial participants with poorly controlled blood glucose;
• Severe infection occurring within 4 weeks prior to study randomization, among others;
• Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.;
• Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
• Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;
• Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
• Inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, etc.;
• History of allergy to the investigational drug, etc.;
• History of solid organ transplantation, autologous or allogeneic stem cell transplantation;
• Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;
• History of severe neurological or psychiatric disorders;
• Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization;
• Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Shanghai East Hospital — Shanghai
• Shanghai Pulmonary Hospital — Shanghai

Identifiers

NCT: NCT07642024 · BL-B01D1-319

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗