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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: QL1706 injection
* Drug: Vinorelbine Tartrate
* Drug: Paclitaxel
* Drug: Cisplatin
* Drug: Carboplatin
* Drug: Pemetrexed
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures. Histopathologically confirmed squamous or non-squamous non-small cell lung cancer Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0) treatment. Participants were enrolled to receive adjuvant therapy within 8 weeks after surgery (≤56 days) and had to recover sufficiently from surgery. Non-squamous NSCLC subjects without EGFR-sensitizing mutation or ALK fusion gene. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Subjects (including women and men) agreed to use effective contraception from the time of signing the informed consent to 180 days after the last use of the study drug. Exclusion Criteria: Currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an investigational device within 4 weeks prior to the first dose of study treatment. Previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy. Cardiovascular and cerebrovascular diseases with clinical significance. Gastrointestinal disease of clinical significance. Clinically significant lung damage. Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive. Active uncontrolled hepatitis B or active hepatitis C. Administer a live vaccine within 30 days prior to the first dose of study treatment. Other malignancies occurred within 5 years prior to study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ.) Previously allergic to macromolecular protein preparations, or to any component of QL1706 and other investigational drugs; history of severe allergy to chemotherapy drugs (pemetrexed, vinorelbine, paclitaxel, cisplatin, carboplatin) or their preventive drugs, etc. History of psychotropic substance abuse, alcohol or drug abuse; prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QL1706 plus Platinum-based chemotherapy<br>QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy | Drug: QL1706 injection<br>* QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy<br>Drug: Vinorelbine Tartrate<br>* Vinorelbine 25mg/m2（D1、D8）Q3W IV, 2-4 cycles<br>Drug: Paclitaxel<br>* Paclitaxel 175mg/m2（D1） Q3W IV, 2-4 cycles<br>Drug: Cisplatin<br>* Cisplatin 75mg/m2（D1）Q3W IV, 2-4 cycles<br>Drug: Carboplatin<br>* Carboplatin AUC=5（D1） Q3W IV, 2-4 cycles<br>Drug: Pemetrexed<br>* Pemetrexed 500mg/m2（D1） Q3W IV, 2-4 cycles<br>|
| Placebo Comparator: Placebo plus Platinum-based chemotherapy<br>Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy | Drug: Vinorelbine Tartrate<br>* Vinorelbine 25mg/m2（D1、D8）Q3W IV, 2-4 cycles<br>Drug: Paclitaxel<br>* Paclitaxel 175mg/m2（D1） Q3W IV, 2-4 cycles<br>Drug: Cisplatin<br>* Cisplatin 75mg/m2（D1）Q3W IV, 2-4 cycles<br>Drug: Carboplatin<br>* Carboplatin AUC=5（D1） Q3W IV, 2-4 cycles<br>Drug: Pemetrexed<br>* Pemetrexed 500mg/m2（D1） Q3W IV, 2-4 cycles<br>Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator. | DFS was defined as the time from randomization to first recurrence of NSCLC, appearance of new primary NSCLC, or death from any cause, whichever occurred first. Tumor recurrence includes local recurrence and distant metastasis. | Up to approximately 84 months | 
| Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator. |  | Up to approximately 84 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the time from random to death from any cause. OS will be measured in the PD-L1 subpopulation and in the ITT population. | Up to approximately 108 months | 
| Percentage of Participants Who are Survival at Year 4 | OS rates will be measured in the PD-L1 subpopulation and in the ITT population. | Year 4 | 
| Percentage of Participants Who are Disease-Free at Year 3 | DFS rates will be measured in the PD-L1 subpopulation and in the ITT population. | Year 3 | 
| Percentage of Participants Who are Disease-Free at Year 5 | DFS rates will be measured in the PD-L1 subpopulation and in the ITT population. | Year 5 | 
| DFS Within Selected Populations | Assessed by Investigator | Up to approximately 108 months | 
| Percentage of Participants with Adverse Events and Serious Adverse Events |  | Up to approximately 108 months |