CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 632 target
Drug / intervention
QL1706 injection +6 moredrug
Likely dose
QL1706 injection 5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05487391
NCT05487391Phase 3RecruitingOn TrackUpdated 20mo ago
Long Recruiting
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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.

Qilu Pharmaceutical Co., Ltd.·interventional·Posted Aug 4, 2022·Updated Oct 15, 2024

In Brief

A Phase 3 clinical trial evaluating QL1706 injection, Vinorelbine Tartrate, and 5 other interventions for Carcinoma, Non-Small-Cell Lung. Currently recruiting, targeting 632 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
2023202420252026202720282029
First PostedAug 4, 2022
Enrollment StartDec 8, 2022
Primary CompletionAug 31, 2027
Study CompletionMay 22, 2029
TodayJul 1, 2026
Enrollment to primary: 4.7 yearsPosted 3.9 years agoPrimary completion in 1.2 years

Interventions

QL1706 injectiondrug

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

Vinorelbine Tartratedrug

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

Paclitaxeldrug

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

Cisplatindrug

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

Carboplatindrug

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

Pemetrexeddrug

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

Placebodrug

Placebo