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Small Cell Lung CancerPhase 3NCT06500026

A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)

A Phase 3 study testing BL-B01D1 and Topotecan in people with Small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent small cell lung cancer after failure of anti-PD-1/PD-L1 Monoclonal Antibodies and platinum-based chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
BL-B01D1 and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
722 participants
Where
1 siteChina
Study dates
7 Aug 2024to Dec 2026
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 and follow the requirements of the protocol;
  • Age ≥18 years old;
  • Expected survival time ≥3 months;
  • Patients with recurrent small-cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy;
  • Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
  • Must have at least one measurable lesion according to RECIST v1.1 definition;
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  • ECOG 0 or 1;
  • Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • The organ function level must meet the requirements on the premise that blood transfusion is not allowed within 14 days before the screening period, and no cell growth factor drugs are allowed;
  • A serum pregnancy test must be performed within 7 days before the start of treatment for premenopausal fertile women, and the result must be negative and must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Who cannot join

  • The patient has histological or cytologic evidence of non-small cell lung cancer or mixed components of small cell lung cancer/non-small cell lung cancer;
  • Prior to randomization, chemotherapy, targeted therapy, or biological therapy were used within 4 weeks or 5 half-lives, small molecule targeted therapy was used within 5 days, or palliative radiotherapy was used within 2 weeks;
  • Patients with recurrent small cell lung cancer who are eligible for curative local therapy;
  • Received chemotherapy with TOP I inhibitor;
  • Received anti-EGFR and/or HER3 antibody /ADC drugs;
  • History of severe heart disease or cerebrovascular disease;
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  • Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
  • Complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
  • Diagnosis of active malignancy within 3 years before randomization;
  • Hypertension poorly controlled by two antihypertensive drugs;
  • Patients with poor glycemic control;
  • A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
  • Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
  • Patients with active central nervous system metastases;
  • Severe infection within 4 weeks before randomization; There was evidence of pulmonary infection or active pulmonary inflammation requiring clinical intervention within 2 weeks before randomization;
  • Patients with massive or symptomatic effusions or poorly controlled effusions;
  • Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;
  • Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
  • Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
  • Patients with inflammatory bowel disease, extensive bowel resection history, immune enteritis history, intestinal obstruction, chronic diarrhea or Gilbert's syndrome;
  • Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
  • Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
  • A history of severe neurological or mental illness;
  • Subjects who were scheduled to receive live vaccine or received live vaccine within 28 days before study randomization;
  • Other circumstances that were assessed by the investigator as inappropriate for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer After Failure of Anti-PD-1/PD-L1 Monoclonal Antibodies and Platinum-based Chemotherapy

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent small cell lung cancer after failure of anti-PD-1/PD-L1 Monoclonal Antibodies and platinum-based chemotherapy.

Being tested
BL-B01D1, Topotecan
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.

  • TopotecanDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT06500026
Study groupRoleWhat they receive
BL-B01D1ExperimentalParticipants receive BL-B01D1 as intravenous infusion for 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
TopotecanExperimentalParticipants receive Topotecan as intravenous infusion for 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: Topotecan

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 BIRC is defined as the time between the date subjects are 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 posted15 Jul 2024
  2. Study start7 Aug 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (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
722 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06500026
Sponsor's protocol ID
BL-B01D1-304
Status last verified
Apr 2026
First submitted
8 Jul 2024
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhao Y, Zhao H, Wang Q, Yang K, Li Y, Fu Z, Yang W, He Z, Wang Y, Ma Y, Yang Y, Fang W, Xiao S, Zhu H, Zhu Y, Zhang L, Huang Y. Izalontamab Brengitecan (Iza-Bren), a First-in-Class EGFR-HER3 Bispecific Antibody-Drug Conjugate in Extensive-Stage Small Cell Lung Cancer: Results From a Phase Ib Study. J Clin Oncol. 2026 Jul 24:JCO2600243. doi: 10.1200/JCO-26-00243. Online ahead of print.

    PubMed 42497381

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BL-B01D1 and Topotecan in people with Small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site 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 11 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT06500026, which also lists 1 linked publication.

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 17 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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