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A Study of IBI110 in Combination With Sintilimab and Chemotherapy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

NCT05026593 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-19

No results posted yet for this study

Summary

IBI110 is an investigational drug under evaluation for treatment of small cell lung cancer. The purpose of the study was to assess the Efficacy and Safety of IBI110 in combination with Sintilimab and chemotherapy with untreated ES-SCLC.

Conditions

Interventions

DRUG

Carboplatin

Carboplatin will be administered after completion of Sintilimab by IV infusion to achieve an initial target AUC of 5 mg/mL/min on Day 1.

DRUG

Cisplatin

Cisplatin 75 mg/m\^2 will be administered after completion of Sintilimab by IV infusion on Day 1.

DRUG

Etoposide

Etoposide 100 mg/m\^2 will be administered by IV infusion following carboplatin or cisplatin administration, during the induction phase on Day 1 through 3 of each cycle. On Days 2 and 3, patients will receive etoposide alone.

DRUG

Sintilimab

Sintilimab 200 mg will be administered by IV infusion following IBI110 on Day 1 of each 21-day .

DRUG

IBI110

IBI110 RP2D will be administered by IV infusion on Day 1 of each 21-day .

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2023-02-16
Completion
2023-06-26

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT05026593 on ClinicalTrials.gov