Carcinoma, Non-Small-Cell Lung
Conditions
Brief 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.
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
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 10 weeks after surgery (≤70 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator. | Up to approximately 84 months | 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. |
| Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator. | Up to approximately 84 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who are Disease-Free at Year 3 | Year 3 | DFS rates will be measured in the PD-L1 subpopulation and in the ITT population. |
| Percentage of Participants Who are Disease-Free at Year 5 | Year 5 | DFS rates will be measured in the PD-L1 subpopulation and in the ITT population. |
| Overall Survival (OS) | Up to approximately 108 months | 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. |
| Percentage of Participants with Adverse Events and Serious Adverse Events | Up to approximately 108 months | — |
| DFS Within Selected Populations | Up to approximately 108 months | Assessed by Investigator |
| Percentage of Participants Who are Survival at Year 4 | Year 4 | OS rates will be measured in the PD-L1 subpopulation and in the ITT population. |
Countries
China
Contacts
Primary ContactXiusong Qiu
Outcome results
None listed