Actively Recruiting
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.
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2024-10-15
632
Participants Needed
1
Research Sites
336 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agreed to participate and signed informed consent
- Diagnosed with squamous or non-squamous non-small cell lung cancer
- Stage II to IIIB disease confirmed by the 8th AJCC edition
- Complete surgical removal of tumor (R0 resection) performed
- Starting adjuvant treatment within 10 weeks (70 days) after surgery and recovered sufficiently
- Non-squamous NSCLC patients without EGFR-sensitizing mutation or ALK fusion gene
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Agreed to use effective contraception from consent until 180 days after last study drug use
You will not qualify if you...
- Participated in another investigational drug or device study within 4 weeks before first study drug dose
- Previous neoadjuvant or adjuvant chemotherapy or immune checkpoint inhibitor treatment
- Significant cardiovascular or cerebrovascular disease
- Significant gastrointestinal disease
- Significant lung damage
- Positive for HIV or Treponema pallidum antibodies
- Active uncontrolled hepatitis B or hepatitis C
- Received live vaccine within 30 days before first study drug dose
- Other malignancies within 5 years before enrollment (with some exceptions)
- Allergic to macromolecular protein drugs, QL1706 components, chemotherapy drugs, or preventive drugs
- History of psychotropic substance abuse, alcohol or drug abuse
- History of neurological or psychiatric disorders such as epilepsy or dementia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital, Shanghai. China
Shanghai, China
Actively Recruiting
Research Team
X
Xiusong Qiu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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