RecruitingPhase 3NCT05487391

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.

QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III Clinical Study.


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

632 participants

Start Date

Dec 8, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (QL1706, which targets PD-1 and CTLA-4 checkpoints) to standard platinum-based chemotherapy improves outcomes after surgery for people with Stage II–IIIB non-small cell lung cancer (NSCLC) that has been completely removed. **You may be eligible if...** - You are 18 or older - You have been diagnosed with Stage II–IIIB NSCLC (squamous or non-squamous) confirmed by biopsy - Your cancer was completely removed by surgery (R0 resection) - You are starting adjuvant (post-surgery) treatment within 10 weeks of your operation - If non-squamous: your tumor does not have EGFR mutations or ALK fusions - Your general health status is good (ECOG 0–1) **You may NOT be eligible if...** - You have previously received neoadjuvant or adjuvant chemotherapy or immunotherapy for this cancer - You have HIV, syphilis, or active hepatitis - You have significant cardiovascular, gastrointestinal, or lung problems - You are currently enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQL1706 injection

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

DRUGVinorelbine Tartrate

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

DRUGPaclitaxel

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

DRUGCisplatin

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

DRUGCarboplatin

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

DRUGPemetrexed

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

DRUGPlacebo

Placebo


Locations(1)

Shanghai Pulmonary Hospital, Shanghai. China

Shanghai, China

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NCT05487391


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