Health Trials

A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer

ConditionExtensive-stage Small-cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This Phase II study is a clinical study exploring the efficacy and safety of BL-M14D1 in combination with Atezolizumab in patients with extensive-stage 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;

No gender restriction;

Age: ≥18 years;

Expected survival time ≥3 months;

Disqualifiers

Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;

Previous treatment with ADC drugs using topoisomerase I inhibitors as toxins;

Small cell carcinoma with non-small cell carcinoma components indicated by pathology must be excluded;

Use of immunomodulatory drugs within 2 weeks before the first dose of the study;

Trial design

Design model

Single group

Treatments tested in this trial

  • BL-M14D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Atezolizumab

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: BL-M14D1+ AtezolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

Time frame
Up to approximately 12 months
2

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-M14D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M14D1.

Time frame
Up to approximately 12 months

Secondary 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 12 months
2

Disease Control Rate (DCR)

The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).

Time frame
Up to approximately 12 months
3

Duration of Response (DOR)

The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

Time frame
Up to approximately 12 months
4

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 12 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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