Squamous Non-small-cell Lung CancerPhase 2/3NCT07739199
A Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)
A Phase 2/3 study testing BL-B01D1, PD-1/VEGF bispecific antibody and Paclitaxel in people with Squamous 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 designed to evaluate the efficacy and safety of BL-B01D1 in combination with PD-1/VEGF bispecific antibody in first-line patients with locally advanced or metastatic squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Non-small-cell Lung Cancer
- What is being tested?
- BL-B01D1, PD-1/VEGF bispecific antibody and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2026to Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- Age ≥18 years;
- Expected survival time ≥3 months;
- Patients with locally advanced or metastatic squamous non-small cell lung cancer;
- Agree to provide tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic disease;
- Must have at least one measurable lesion as defined by RECIST v1.1;
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
- Organ function levels must meet the specified requirements;
- Urinary protein ≤1+ or <1000 mg/24h;
- For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test excluding pregnancy, and patients must be non-lactating; all enrolled patients (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.
Who cannot join
- Prior histological or cytological evidence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;
- Indications of the presence of EGFR-sensitive mutations, among others;
- Patients who have received prior systemic therapy;
- Prior treatment with agents targeting the mechanism of tumor immune action;
- Prior treatment with ADC drugs that use topoisomerase I inhibitors as the toxin, among others;
- Receipt of radical radiotherapy, major surgery, or large-field radiotherapy within 4 weeks before study randomization;
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- History of severe heart disease or cerebrovascular disease;
- Receipt of long-term systemic corticosteroid therapy (e.g., prednisone >10 mg/day) before the first dose;
- Active autoimmune diseases and inflammatory diseases requiring systemic treatment within 2 years;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- Prolonged QTc interval, complete left bundle branch block, among others;
- Diagnosis of active malignancy within 3 years before study randomization;
- Hypertension inadequately controlled by two antihypertensive medications;
- Patients with poorly controlled blood glucose levels;
- History of ILD requiring steroid therapy, current ILD, or grade ≥2 radiation pneumonitis, among others;
- Pulmonary diseases leading to clinically severe impairment of respiratory function;
- Patients with active central nervous system metastases;
- Severe infection occurring within 4 weeks before study randomization;
- Presence of large serous cavity effusions or symptomatic serous cavity effusions, among others;
- Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
- Severe non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;
- Trial participants with clinically significant bleeding or a significant bleeding tendency within 4 weeks prior to signing informed consent;
- Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune enteritis, intestinal obstruction, or chronic diarrhea, among others;
- History of allergy to recombinant humanized antibodies or hypersensitivity to any excipient of BL-B01D1;
- History of autologous or allogeneic stem cell transplantation;
- Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;
- History of severe neurological or psychiatric disorders;
- Receipt of other unapproved clinical study drugs or treatments within 4 weeks before study randomization;
- Trial participants planning to receive or having received live vaccines within 28 days before 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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Li Zhang
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
Xiaorong Dong
About this study
Official title: A Phase II/III Clinical Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)
This trial is a registrational Phase II/III randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in combination with PD-1/VEGF bispecific antibody in first-line patients with locally advanced or metastatic squamous non-small cell lung cancer.
Read the detailed description
The entire study consists of two stages, Phase II and Phase III, both of which are randomized, open-label studies.
- Conditions
- Squamous Non-small-cell Lung Cancer
- Being tested
- BL-B01D1, PD-1/VEGF bispecific antibody, Paclitaxel, Carboplatin
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.
PD-1/VEGF bispecific antibodyDrug
Administration by intravenous infusion for a cycle of 3 weeks.
PaclitaxelDrug
Administration by intravenous infusion for a cycle of 3 weeks.
CarboplatinDrug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-B01D1 + PD-1/VEGF bispecific antibody | Experimental | Participants receive BL-B01D1 + PD-1/VEGF bispecific antibody 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: PD-1/VEGF bispecific antibody |
| Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody | Active comparator | Participants receive Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody 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: PD-1/VEGF bispecific antibody; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: Investigator-assessed Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Measured: Up to approximately 24 months
Phase II: Investigator-assessed Progression-free Survival (PFS)
Investigator-assessed progression-free survival (PFS) per RECIST v1.1 is defined as the time from treatment initiation until the first documented disease progression according to RECIST v1.1 criteria, or death from any cause, whichever occurs first, as determined by the local treating investigator.
Measured: Up to approximately 24 months
Phase III: BICR-assessed Progression-free Survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Measured: Up to approximately 24 months
Secondary outcomes (15)
Phase II/III: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
Phase II/III: Progression-free Survival (PFS)
Progression-free Survival (PFS) is defined as the time from randomization or start of treatment until the first documented evidence of disease progression or death from any cause, whichever occurs first.
Measured: Up to approximately 24 months
Phase II/III: Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Measured: Up to approximately 24 months
Phase II/III: Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Measured: Up to approximately 24 months
Phase II/III: Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Measured: Up to approximately 24 months
Phase II/III: Cmax
Cmax is defined as the maximum observed drug concentration in plasma after administration.
Measured: Up to approximately 24 months
Phase II/III: Tmax
Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.
Measured: Up to approximately 24 months
Phase II/III: T1/2
T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.
Measured: Up to approximately 24 months
Phase II/III: AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Measured: Up to approximately 24 months
Phase II/III: CL (Clearance)
Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time.
Measured: Up to approximately 24 months
Phase II/III: Ctrough
Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.
Measured: Up to approximately 24 months
Phase II/III: Anti-drug Antibody (ADA)
Anti-drug Antibody (ADA) refers to endogenous antibodies generated in subjects that specifically bind to the investigational drug.
Measured: Up to approximately 24 months
Phase II/III: Neutralizing Antibody(NAb)
Frequency of anti-BL-B01D1 neutralizing antibodies will be investigated.
Measured: Up to approximately 24 months
Phase II: Drug-Drug Interaction (DDI)
Drug-Drug Interaction (DDI) is a situation in which one drug affects the activity, metabolism, or toxicity of another drug when they are administered concurrently (or within a short time interval).
Measured: Up to approximately 24 months
Phase III: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous 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
- 200 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
- NCT07739199
- Sponsor's protocol ID
- BL-B01D1-312
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 26 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Clinical Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)
- ClinicalTrials.gov ID
- NCT07739199
- Acronym / sponsor ID
- BL-B01D1-312
- Conditions
- Squamous Non-small-cell Lung Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 31 Jul 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 designed to evaluate the efficacy and safety of BL-B01D1 in combination with PD-1/VEGF bispecific antibody in first-line patients with locally advanced or metastatic squamous non-small cell lung cancer.
Detailed description
The entire study consists of two stages, Phase II and Phase III, both of which are randomized, open-label studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL-B01D1 + PD-1/VEGF bispecific antibody | Experimental | Drug: BL-B01D1, Drug: PD-1/VEGF bispecific antibodyParticipants receive BL-B01D1 + PD-1/VEGF bispecific antibody 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. |
| Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody | Active comparator | Drug: PD-1/VEGF bispecific antibody, Drug: Paclitaxel, Drug: CarboplatinParticipants receive Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- Age ≥18 years;
- Expected survival time ≥3 months;
- Patients with locally advanced or metastatic squamous non-small cell lung cancer;
- Agree to provide tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic disease;
Key exclusion criteria (30 listed)
- Prior histological or cytological evidence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;
- Indications of the presence of EGFR-sensitive mutations, among others;
- Patients who have received prior systemic therapy;
- Prior treatment with agents targeting the mechanism of tumor immune action;
- Prior treatment with ADC drugs that use topoisomerase I inhibitors as the toxin, 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 + PD-1/VEGF bispecific antibody |
| PD-1/VEGF bispecific antibodyAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-B01D1 + PD-1/VEGF bispecific antibody, Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody |
| PaclitaxelAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody |
| CarboplatinAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Paclitaxel + Carboplatin + PD-1/VEGF bispecific antibody |
Primary outcome
Phase II: Investigator-assessed Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Phase II: Investigator-assessed Progression-free Survival (PFS)
Time frame: Up to approximately 24 months
Investigator-assessed progression-free survival (PFS) per RECIST v1.1 is defined as the time from treatment initiation until the first documented disease progression according to RECIST v1.1 criteria, or death from any cause, whichever occurs first, as determined by the local treating investigator.
Phase III: BICR-assessed Progression-free Survival (PFS)
Time frame: Up to approximately 24 months
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
15 secondary outcomes
Phase II/III:Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Phase II/III: Progression-free Survival (PFS)
Time frame: Up to approximately 24 months
Phase II/III: Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Phase II/III: Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Phase II/III: Duration of Response (DOR)
Time frame: Up to approximately 24 months
Phase II/III: Cmax
Time frame: Up to approximately 24 months
Phase II/III: Tmax
Time frame: Up to approximately 24 months
Phase II/III: T1/2
Time frame: Up to approximately 24 months
Phase II/III: AUC0-t
Time frame: Up to approximately 24 months
Phase II/III: CL (Clearance)
Time frame: Up to approximately 24 months
Phase II/III: Ctrough
Time frame: Up to approximately 24 months
Phase II/III: Anti-drug Antibody (ADA)
Time frame: Up to approximately 24 months
Phase II/III: Neutralizing Antibody(NAb)
Time frame: Up to approximately 24 months
Phase II: Drug-Drug Interaction (DDI)
Time frame: Up to approximately 24 months
Phase III: Overall Survival (OS)
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 26 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, PD-1/VEGF bispecific antibody and Paclitaxel in people with Squamous 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 30 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: opening soon, as of the sponsor's last update on 26 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?
Phase II: Investigator-assessed Objective Response Rate (ORR) (time frame: Up to approximately 24 months). The study lists 3 primary outcomes in all. 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 26 Aug 2026.