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A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection.

NCT05487391 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 632

Last updated 2024-10-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage II-IIIB NSCLC without EGFR-sensitizing mutations and ALK fusions after complete surgical resection.The subjects were randomly divided into two groups according to 1:1, with about 316 subjects in the experimental group and the control group.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

QL1706 injection

QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy

DRUG

Vinorelbine Tartrate

Vinorelbine 25mg/m2（D1、D8）Q3W IV, 2-4 cycles

DRUG

Paclitaxel

Paclitaxel 175mg/m2（D1） Q3W IV, 2-4 cycles

DRUG

Cisplatin

Cisplatin 75mg/m2（D1）Q3W IV, 2-4 cycles

DRUG

Carboplatin

Carboplatin AUC=5（D1） Q3W IV, 2-4 cycles

DRUG

Pemetrexed

Pemetrexed 500mg/m2（D1） Q3W IV, 2-4 cycles

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Caicun Zhou, MD, PhD · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2027-08-31
Completion
2029-05-22

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 NCT05487391 on ClinicalTrials.gov