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AzTrials

Non-small Cell Lung CancerPhase 3NCT06838273

A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)

A Phase 3 study testing BL-B01D1 and Osimertinib in people with Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site 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
Search all trials

Trial summary

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated locally advanced or metastatic Non-small Cell Lung Cancer. 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 Osimertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
1 siteChina
Study dates
24 Feb 2025to Dec 2028
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

  • Sign the informed consent form voluntarily and follow the protocol requirements;
  • Age ≥18 years old;
  • Expected survival time ≥3 months;
  • Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer;
  • Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples;
  • Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions at or after diagnosis for testing, including EGFR mutation type;
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  • At least one measurable lesion meeting the RECIST v1.1 definition was required;
  • ECOG 0 or 1;
  • The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as 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 and colony-stimulating factor are not allowed within 14 days before the screening period;
  • Urinary protein ≤2+ or < 1000mg/24h;
  • For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be 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

  • Previous histologic or cytological evidence of small cell or mixed small/non-small cell components;
  • Patients with previous systemic therapy;
  • Patients had received EGFR-TKI therapy;
  • Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization;
  • History of severe heart disease and cerebrovascular disease;
  • Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
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  • QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
  • Were diagnosed with active malignancy within 3 years before randomization;
  • Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg);
  • Patients with poor glycemic control;
  • A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis, or a suspicion of such disease;
  • Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
  • Patients with active central nervous system metastasis;
  • Had a severe infection within 4 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;
  • Serious 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 a history of inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;
  • Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
  • Had autologous or allogeneic stem cell transplantation history;
  • 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 drugs or treatments within 4 weeks before randomization;
  • Subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization;
  • Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.

Trial locations and contacts

1 site 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

China1 site, 1 recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

    Caicun Zhou

    Recruiting

Other trials in China

About this study

Official title: A Phase III Randomized Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated locally advanced or metastatic Non-small Cell Lung Cancer.

Being tested
BL-B01D1, Osimertinib
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, 80mg daily for a cycle of 3 weeks.

  • OsimertinibDrug

    Oral administration, 80mg daily for a cycle of 3 weeks.

Study groups in NCT06838273
Study groupRoleWhat they receive
BL-B01D1 in Combination with OsimertinibExperimentalParticipants receive BL-B01D1 in Combination with Osimertinib 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; Drug: Osimertinib
OsimertinibActive comparatorParticipants receive Osimertinib 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: Osimertinib

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 36 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 36 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 36 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 36 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 36 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 36 months

  6. Anti-drug antibody (ADA)

    Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.

    Measured: Up to approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2025
  2. Study start24 Feb 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (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
720 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06838273
Sponsor's protocol ID
BL-B01D1-308
Status last verified
Apr 2026
First submitted
16 Feb 2025
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
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 Osimertinib 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 13 inclusion and 26 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 20 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?

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?

Progression-free survival (PFS) (time frame: Up to approximately 36 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 NCT06838273.

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 20 Apr 2026.

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