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A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)

ConditionNon-small Cell Lung Cancer Stage III
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the informed consent form and comply with the protocol requirements;

Age ≥ 18 years and ≤ 75 years, regardless of gender;

Expected survival time ≥ 3 months;

Unresectable Stage III non-small cell lung cancer;

Disqualifiers

SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;

The trial participant has received other chemotherapy, radiotherapy, etc., for NSCLC apart from radical chemoradiotherapy;

Major surgery within 4 weeks prior to the first dose;

Prior treatment with ADC drugs using topoisomerase I inhibitors as toxins, or antibodies/ADCs targeting EGFR and/or HER3;

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 for a cycle of 3 weeks.

Treatment groups

418 Participants
are divided into 2 treatment groups
Group A: BL-B01D1+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 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.

Time frame
Up to approximately 24 months

Secondary outcomes

1

Overall Survival (OS)

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

Time frame
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).

Time frame
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.

Time frame
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.

Time frame
Up to approximately 24 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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