A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGF… (NCT07642024) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
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)
China90 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines BL-B01D1 — an antibody-drug conjugate — with osimertinib before and after surgery; since my tumor needs to have an EGFR mutation to be eligible, can you confirm whether my specific mutation type would likely qualify, and what testing I'd need done first?
2The main thing this trial is measuring is called Major Pathological Response, which means how much the tumor shrinks or disappears before surgery — can you explain what achieving or not achieving that response would mean for my treatment path going forward?
3Since this is a Phase 2/3 trial and BL-B01D1 is still being studied in combination with osimertinib, what do we currently know about the safety profile of this combination, and are there risks I should weigh compared to established perioperative options like osimertinib alone?
4The trial isn't recruiting yet, so there could be a gap before I could even enroll — given my diagnosis, is waiting for this trial to open a realistic option, or would starting standard treatment now be the safer approach for my situation?
5Surgery is a central part of this trial, happening between the pre-operative and post-operative treatment phases — how would participating in a structured perioperative study like this affect the timing of my operation, and could it complicate my surgical planning?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.