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Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer

NCT05309629 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-17

No results posted yet for this study

Summary

This is an open label, phase 2 clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetic (PK) profile, and immunogenicity of QL1706 plus carboplatin and etoposide as first-line therapy in patients with extensive-stage small cell lung cancer.

Conditions

  • Extensive-stage Small-cell Lung Cancer

Interventions

DRUG

QL1706

Intravenous infusions of QL1706 5mg/kg on Day 1 of every 21-day cycle.

DRUG

Carboplatin

Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle for 4-6 cycles.

DRUG

Etoposide

Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for 4-6 cycles.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-04-18
Primary Completion
2023-02-01
Completion
2024-12-13

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 NCT05309629 on ClinicalTrials.gov