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Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

NCT03711305 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2022-04-18

No results posted yet for this study

Summary

This randomized, double-blinded, placebo-controlled phase III, multicenter study is designed to evaluate the safety and efficacy of SHR-1316 in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.

Conditions

  • Extensive-stage Small Cell Lung Cancer

Interventions

DRUG

SHR-1316

SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.

DRUG

Carboplatin

Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

DRUG

Etoposide

Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

DRUG

Placebo

Placebo intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Shi · Jiangsu HengRui Medicine Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-30
Primary Completion
2022-10-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT03711305 on ClinicalTrials.gov