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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)

ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BL-B01D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Osimertinib

    Drug

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

  • Osimertinib

    Drug

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

Treatment groups

720 Participants
are divided into 2 treatment groups
Group A: BL-B01D1 in Combination with OsimertinibExperimental treatment 2 interventions
Group B: OsimertinibActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
Up to approximately 36 months

Secondary outcomes

1

Overall survival (OS)

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

Time frame
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).

Time frame
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.

Time frame
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.

Time frame
Up to approximately 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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