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A Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With ES-SCLC

NCT04878016 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2024-02-02

No results posted yet for this study

Summary

This is a randomized, Phase III, multicenter, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of ZKAB001 in combination with carboplatin + etoposide compared with treatment with placebo + carboplatin + etoposide in patients who have ES-SCLC and are untreated for their extensive-stage disease.

Conditions

  • Extensive-stage Small-cell Lung Cancer

Interventions

BIOLOGICAL

ZKAB001

Patients will receive ZKAB001 5mg/kg administered by IV infusion every 21days，

DRUG

Placebo

Patients will receive placebo administered by IV infusion every 21days.

DRUG

Carboplatin

Carboplatin should be administered after completion of placebo/ZKAB001 by IV infusion over 30-60 minutes to achieve an initial target AUC of 5 mg/mL/min. Carboplatin and etoposide will be used for a total of 4 cycles， followed by placebo/ZKAB001 maintenance therapy.

DRUG

Etoposide

Etoposide (100 mg/m\^2) should be administered intravenously over 60 minutes following carboplatin administration. On Days 2 and 3 of each cycle, etoposide 100 mg/m2) should be administered intravenously over 60 minutes. Carboplatin and etoposide will be used for a total of 4 cycles， followed by placebo/ZKAB001 maintenance therapy.

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2023-10-13
Completion
2023-10-13

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878016 on ClinicalTrials.gov