Clinical trial NCT05487391: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator.
timeFrame: Up to approximately 84 months
measure: Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator.
timeFrame: Up to approximately 84 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 108 months
measure: Percentage of Participants Who are Survival at Year 4
timeFrame: Year 4
measure: Percentage of Participants Who are Disease-Free at Year 3
timeFrame: Year 3
measure: Percentage of Participants Who are Disease-Free at Year 5
timeFrame: Year 5
measure: DFS Within Selected Populations
timeFrame: Up to approximately 108 months
measure: Percentage of Participants with Adverse Events and Serious Adverse Events
timeFrame: Up to approximately 108 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital, Shanghai. China
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Caicun Zhou, MD, PhD
role: STUDY_CHAIR
References: