- ICH GCP
- US Clinical Trials Registry
- 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.
August 3, 2022 updated by: Qilu Pharmaceutical Co., Ltd.
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.
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
632
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lianghua Fang
- Phone Number: 86-13645192882
- Email: lianghua.fang@qilu-pharma.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: QL1706 plus Platinum-based chemotherapy
QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy
|
QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy
Vinorelbine 25mg/m2(D1、D8)Q3W IV, 2-4 cycles
Paclitaxel 175mg/m2(D1) Q3W IV, 2-4 cycles
Cisplatin 75mg/m2(D1)Q3W IV, 2-4 cycles
Carboplatin AUC=5(D1) Q3W IV, 2-4 cycles
Pemetrexed 500mg/m2(D1) Q3W IV, 2-4 cycles
|
Placebo Comparator: Placebo plus Platinum-based chemotherapy
Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy
|
Placebo
Vinorelbine 25mg/m2(D1、D8)Q3W IV, 2-4 cycles
Paclitaxel 175mg/m2(D1) Q3W IV, 2-4 cycles
Cisplatin 75mg/m2(D1)Q3W IV, 2-4 cycles
Carboplatin AUC=5(D1) Q3W IV, 2-4 cycles
Pemetrexed 500mg/m2(D1) Q3W IV, 2-4 cycles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator.
Time Frame: 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.
|
Up to approximately 84 months
|
Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator.
Time Frame: Up to approximately 84 months
|
Up to approximately 84 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: 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.
|
Up to approximately 108 months
|
Percentage of Participants Who are Survival at Year 4
Time Frame: 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
Time Frame: 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
Time Frame: Year 5
|
DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.
|
Year 5
|
DFS Within Selected Populations
Time Frame: Up to approximately 108 months
|
Assessed by Investigator
|
Up to approximately 108 months
|
Percentage of Participants with Adverse Events and Serious Adverse Events
Time Frame: Up to approximately 108 months
|
Up to approximately 108 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Caicun Zhou, MD, PhD, Shanghai Pulmonary Hospital, Shanghai, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2022
Primary Completion (Anticipated)
October 1, 2028
Study Completion (Anticipated)
October 1, 2031
Study Registration Dates
First Submitted
August 1, 2022
First Submitted That Met QC Criteria
August 3, 2022
First Posted (Actual)
August 4, 2022
Study Record Updates
Last Update Posted (Actual)
August 4, 2022
Last Update Submitted That Met QC Criteria
August 3, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Folic Acid Antagonists
- Carboplatin
- Paclitaxel
- Vinorelbine
- Pemetrexed
Other Study ID Numbers
- QL1706-304
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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