RecruitingPhase 2Phase 3NCT07642024

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)

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)

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

90 participants

Start Date

Jul 24, 2026

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria12

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 Criteria25

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.