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AzTrials

Extensive-stage Small-cell Lung CancerPhase 3NCT07502300

A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07)

A Phase 3 study testing BL-B01D1, Tislelizumab and Carboplatin in people with Extensive-stage Small-cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of BL-B01D1 in combination with tislelizumab versus platinum-based chemotherapy in combination with tislelizumab in first-line patients with extensive-stage small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extensive-stage Small-cell Lung Cancer
What is being tested?
BL-B01D1, Tislelizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
562 participants
Where
2 sitesChina
Study dates
15 Jun 2026to Dec 2029
Phase
Phase 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;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Patients with histopathologically and/or cytologically confirmed extensive-stage small cell lung cancer;
  • Agree to provide archived tumor tissue specimens from the primary or metastatic lesions within 3 years, or fresh tissue samples;
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  • Must have at least one measurable lesion as defined by RECIST v1.1;
  • Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;
  • Organ function levels must meet the requirements;
  • Urinary protein ≤ 2+ or < 1000 mg/24h;
  • For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must be negative; patients must not be breastfeeding. All enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after the end of treatment.

Who cannot join

  • Pathology indicates small cell carcinoma containing non-small cell carcinoma components;
  • Patients who have previously received systemic treatment;
  • Previous treatment with ADC drugs where the small molecule toxin is a topoisomerase I inhibitor;
  • Use of immunomodulatory drugs within 14 days prior to the first dose of the study drug;
  • History of severe heart disease or cerebrovascular disease;
  • Receiving long-term systemic corticosteroid therapy at a dose >10 mg/day of prednisone or equivalent prior to the first dose;
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  • Active autoimmune diseases and inflammatory diseases;
  • Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
  • Prolonged QT interval, complete left bundle branch block, etc.;
  • Diagnosis of active malignancy within 3 years prior to study randomization;
  • Hypertension inadequately controlled with two antihypertensive medications;
  • Poorly controlled diabetes mellitus;
  • History of interstitial lung disease (ILD)/pneumonitis requiring steroid therapy, etc.;
  • Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;
  • Patients with active central nervous system (CNS) metastases;
  • Severe infection within 4 weeks prior to study randomization;
  • Presence of large serous cavity effusions, or serous cavity effusions with symptoms, etc.;
  • Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx;
  • Severe, non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;
  • Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
  • Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea;
  • History of allergy to recombinant humanized antibodies or any excipient component 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 prior to study randomization;
  • Subjects planning to receive or having received live vaccines within 28 days prior to study randomization;
  • Other conditions deemed by the investigator to make the subject 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.

Sa Xiao, PHD contact

15013238943

xiaosa@baili-pharm.com

China2 sites, 2 recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

    Caicun Zhou

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Qiming Wang

    Recruiting

Other trials in China

About this study

Official title: A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 for Injection Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer

This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of BL-B01D1 in combination with tislelizumab versus platinum-based chemotherapy in combination with tislelizumab in first-line patients with extensive-stage small cell lung cancer.

Being tested
BL-B01D1, Tislelizumab, Carboplatin, Etoposide
Medical subject headings
Small Cell Lung Carcinoma

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.

  • TislelizumabDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • CarboplatinDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • EtoposideDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT07502300
Study groupRoleWhat they receive
BL-B01D1+TislelizumabExperimentalParticipants receive BL-B01D1+Tislelizumab 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: Tislelizumab
Carboplatin+Etoposide +TislelizumabActive comparatorParticipants receive Carboplatin+Etoposide +Tislelizumab 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: Tislelizumab; Drug: Carboplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

    Measured: Up to approximately 24 months

Secondary outcomes (6)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted30 Mar 2026
  2. Study start15 Jun 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
562 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07502300
Sponsor's protocol ID
BL-B01D1-314
Status last verified
Jul 2026
First submitted
25 Mar 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BL-B01D1, Tislelizumab and Carboplatin in people with Extensive-stage 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 28 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 27 Jul 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 phase mean?

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?

Overall survival (OS) (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?

On the ClinicalTrials.gov record for NCT07502300.

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 27 Jul 2026.

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