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Trial Title:
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.
NCT ID:
NCT05487391
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Vinorelbine
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
QL1706 injection
Description:
QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy
Arm group label:
QL1706 plus Platinum-based chemotherapy
Intervention type:
Drug
Intervention name:
Vinorelbine Tartrate
Description:
Vinorelbine 25mg/m2(D1、D8)Q3W IV, 2-4 cycles
Arm group label:
Placebo plus Platinum-based chemotherapy
Arm group label:
QL1706 plus Platinum-based chemotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel 175mg/m2(D1) Q3W IV, 2-4 cycles
Arm group label:
Placebo plus Platinum-based chemotherapy
Arm group label:
QL1706 plus Platinum-based chemotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin 75mg/m2(D1)Q3W IV, 2-4 cycles
Arm group label:
Placebo plus Platinum-based chemotherapy
Arm group label:
QL1706 plus Platinum-based chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin AUC=5(D1) Q3W IV, 2-4 cycles
Arm group label:
Placebo plus Platinum-based chemotherapy
Arm group label:
QL1706 plus Platinum-based chemotherapy
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed 500mg/m2(D1) Q3W IV, 2-4 cycles
Arm group label:
Placebo plus Platinum-based chemotherapy
Arm group label:
QL1706 plus Platinum-based chemotherapy
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Placebo plus Platinum-based chemotherapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital, Shanghai. China
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou
Start date:
December 8, 2022
Completion date:
May 22, 2029
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05487391