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Non-small Cell Lung CancerPhase 3NCT06382116

A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer(PANKU-Lung01)

A Phase 3 study testing BL-B01D1 and Pemetrexed+Cisplatin or Carboplatin in people with Non-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 locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
BL-B01D1 and Pemetrexed+Cisplatin or Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
432 participants
Where
1 siteChina
Study dates
22 May 2024to Dec 2027
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;
  • Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer;
  • Documented classical EGFR mutations detected from tumor tissue or blood samples;
  • Had not received any systemic therapy other than EGFR-TKIs;
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  • Radiographic disease progression documented during or after third-generation EGFR-TKI therapy for metastatic or locally advanced disease;
  • 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;
  • ECOG score 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 level of organ function 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;
  • Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN;
  • Urine protein ≤2+ or < 1000mg/24h;
  • For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Who cannot join

  • The patient has histologic or cytologic evidence of small cell or mixed small/non-small cell component or squamous non-small cell lung cancer;
  • Chemotherapy, biological therapy, immunotherapy, etc., have been used within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy has been used within 5 days, palliative radiotherapy or anti-tumor therapy has been used within 2 weeks;
  • Previous treatment with: a. an ADC with TOPI inhibitor as toxin; b. any systemic therapy in the context of metastatic/locally advanced disease;
  • The history of severe cardiovascular and cerebrovascular diseases in the past six months prior screening;
  • Thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis more than 4 weeks later was excluded;
  • Complete left bundle branch block, III degree atrioventricular block, frequent and uncontrolled severe arrhythmia;
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  • Other malignancies diagnosed within 3 years before randomization;
  • Hypertension poorly controlled by two antihypertensive drugs;
  • History of interstitial lung disease (ILD) requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
  • Patients with poor glycemic control;
  • Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
  • Patients with active central nervous system (CNS) metastases;
  • Severe infection within 4 weeks before randomization; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;
  • Patients with massive or symptomatic effusions or poorly controlled effusions;
  • Imaging examination showed that the tumor had invaded or wrapped the abdomen, chest, neck, and large blood vessels;
  • 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 or chronic diarrhea;
  • Have a history of allergy to recombinant humanized antibodies or any of the ingredients of BL-B01D1;
  • Human immunodeficiency virus antibody positive, active hepatitis B virus infection, or hepatitis C virus infection;
  • A history of severe neurological or psychiatric illness;
  • Received other unmarketed investigational drug or treatment within 4 weeks before randomization;
  • 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 Platinum Based Chemotherapy (First-line of Systemic Treatment) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After EGFR-TKI Failure

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure.

Being tested
BL-B01D1, Pemetrexed+Cisplatin or Carboplatin
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.

  • Pemetrexed+Cisplatin or CarboplatinDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT06382116
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
Pemetrexed+Cisplatin or CarboplatinExperimentalParticipants receive Pemetrexed +Cisplatin or Carboplatin 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: Pemetrexed+Cisplatin or Carboplatin

What is being measured

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

  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

Secondary outcomes (6)

  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

  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 posted24 Apr 2024
  2. Study start22 May 2024
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2027 (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
432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06382116
Sponsor's protocol ID
BL-B01D1-301
Status last verified
Jul 2026
First submitted
19 Apr 2024
Last updated
23 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 and Pemetrexed+Cisplatin or Carboplatin in people with Non-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 16 inclusion and 24 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 23 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 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?

Progression-free survival (PFS) (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 NCT06382116.

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 23 Jul 2026.

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