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A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC

ConditionNon-squamous Non-small Cell Lung Cancer
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-M07D1 in patients with first-line treatment of HER2-mutant advanced or metastatic non-squamous non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Age at the time of signing the informed consent form is ≥18 years and ≤75 years, regardless of gender;

Expected survival time ≥12 weeks;

Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer;

Disqualifiers

Having undergone surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;

Pathological findings indicating non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;

Concurrent presence of other driver gene mutations for which targeted drug therapy is available and approved for NSCLC indications;

Previous treatment with HER2-targeted therapy or ADC drugs with camptothecin derivatives as the toxin;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BL-M07D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Pembrolizumab

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Pemetrexed

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Carboplatin

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Cisplatin

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: BL-M07D1Experimental treatment 1 intervention
Group B: Pembrolizumab-platinum chemotherapyActive comparator 4 interventions

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 subject's randomization date and 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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