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)
Recruiting now · Phase 2/Phase 3
Conditions studied: Non-small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT07642024
- Run by
- Sichuan Baili Pharmaceutical Co., Ltd.
- People needed
- 90
- Starts
- 2026-07-24
- Expected to finish
- 2032-12-01
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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