Non-small Cell Lung CancerPhase 2/3NCT07642024
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 2/3 study testing BL-B01D1, Osimertinib and Carboplatin in people with Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- BL-B01D1, Osimertinib and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 24 Jul 2026to Dec 2032
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
Caicun Zhou
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Peng Zhang
About this study
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)
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- BL-B01D1, Osimertinib, Carboplatin, Pemetrexed, Cisplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-B01D1Drug
Also called iza-bren, izalontamab brengitecan, BMS-986507
Administration by intravenous infusion for a cycle of 3 weeks.
OsimertinibDrug
Oral administration for a cycle of 3 weeks.
CarboplatinDrug
Administration by intravenous infusion for a cycle of 3 weeks.
PemetrexedDrug
Administration by intravenous infusion for a cycle of 3 weeks.
CisplatinDrug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-B01D1+Osimertinib | Experimental | Participants receive BL-B01D1+Osimertinib 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. Receives: Drug: BL-B01D1; Drug: Osimertinib |
| Osimertinib | Active comparator | Participants receive Osimertinib 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. Receives: Drug: Osimertinib |
| Carboplatin + Pemetrexed or Cisplatin + Pemetrexed | Active comparator | Participants receive Carboplatin + Pemetrexed or Cisplatin + Pemetrexed 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. Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR)
MPR is defined as the presence of viable tumor tissue ≤10% in the surgical specimen at the time of tumor resection.
Measured: Up to approximately 24 months
Secondary outcomes (5)
Pathologic complete response (pCR)
pCR is defined as the absence of any residual tumor (lesions) in the primary tumor upon surgical resection.
Measured: Up to approximately 24 months
Event-Free Survival (EFS)
EFS is defined as the time from randomization to the occurrence of any of the following events, whichever occurs first.
Measured: Up to approximately 24 months
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Measured: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
Measured: Up to approximately 24 months
Anti-drug antibody (ADA)
Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start24 Jul 2026
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642024
- Sponsor's protocol ID
- BL-B01D1-319
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07642024
- Acronym / sponsor ID
- BL-B01D1-319
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BL-B01D1+Osimertinib | Experimental | Drug: BL-B01D1, Drug: OsimertinibParticipants receive BL-B01D1+Osimertinib 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. |
| Osimertinib | Active comparator | Drug: OsimertinibParticipants receive Osimertinib 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. |
| Carboplatin + Pemetrexed or Cisplatin + Pemetrexed | Active comparator | Drug: Carboplatin, Drug: Pemetrexed, Drug: CisplatinParticipants receive Carboplatin + Pemetrexed or Cisplatin + Pemetrexed 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-B01D1Also: iza-bren, izalontamab brengitecan, BMS-986507Administration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-B01D1+Osimertinib |
| OsimertinibOral administration for a cycle of 3 weeks. | Drug | BL-B01D1+Osimertinib, Osimertinib |
| CarboplatinAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Carboplatin + Pemetrexed or Cisplatin + Pemetrexed |
| PemetrexedAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Carboplatin + Pemetrexed or Cisplatin + Pemetrexed |
| CisplatinAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Carboplatin + Pemetrexed or Cisplatin + Pemetrexed |
Primary outcome
Major Pathological Response (MPR)
Time frame: Up to approximately 24 months
MPR is defined as the presence of viable tumor tissue ≤10% in the surgical specimen at the time of tumor resection.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BL-B01D1, Osimertinib and Carboplatin in people with Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.