Histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC)
Conditions
Interventions
Treatment group:QL1706 plus docetaxel
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >=18 years, male or female. 2.Life expectancy of more than 3 months. 3.Histologically or cytologically confirmed locally advanced, metastatic, or recurrent NSCLC that is not amenable to radical surgery or definitive chemoradiotherapy. 4.Patients with non-curatively treatable locally advanced, metastatic, or recurrent NSCLC who have failed first-line treatment with an anti-PD-1/PD-L1 monoclonal antibody combined with platinum-based doublet chemotherapy (excluding docetaxel), or who have failed sequential first- and second-line treatment with PD-1/PD-L1 inhibitors and platinum-based doublet chemotherapy (excluding docetaxel); prior therapies are permitted to include anti-VEGF monoclonal antibodies. 5.At least one measurable lesion according to RECIST v1.1 criteria. 6.ECOG performance status of 0-1. 7.Essential organ function must meet the following requirements: Absolute neutrophil count (ANC) >=1.5 × 10^9/L; Platelets >=100 × 10^9/L; Hemoglobin >=9 g/dL; Total bilirubin 1.5 × ULN, alkaline phosphatase must be =50 mL/min (calculated by Cockcroft-Gault formula); Urine protein qualitative =2+, then 24-hour urine protein quantification must be performed and result in <1 g; Activated partial thromboplastin time (aPTT)/partial thromboplastin time (PTT) <=1.5 × ULN, and international normalized ratio (INR) <=1.5 (stable use of anticoagulants such as low molecular weight heparin or warfarin is acceptable if INR is within the anticipated therapeutic range of the anticoagulant). 8.Fertile males and females of childbearing potential must agree to use effective contraception from the time of signing the main informed consent form until 180 days after the last dose of the study drug. 9.Voluntary participation in the clinical study, with full understanding and awareness of the study, and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Presence of a mixed small-cell lung cancer component on histopathology. Known presence of EGFR sensitizing mutations, EGFR exon 20 insertion mutations, ALK fusions, ROS1 fusions, RET fusions, NTRK fusions, BRAF V600E mutations, MET exon 14 skipping mutations, or HER2 sensitizing mutations (if other genetic alterations are present, the final decision on eligibility will be made by the expert panel). 2.Patients with known leptomeningeal metastasis or symptomatic brain metastases. Patients with asymptomatic brain metastases may be enrolled if assessed as stable by the investigator. 3.Prior receipt of any of the following treatments: a. Treatment with anti-CTLA-4 inhibitors. b. Immunotherapy, chemotherapy, or radiotherapy within 3 weeks prior to the first dose of the study drug (palliative radiotherapy for bone metastases completed >=2 weeks before the first dose is acceptable). c. Systemic corticosteroid therapy (at a dose >10 mg prednisone equivalent per day) or other immunosuppressants within 2 weeks prior to the first dose of the study drug. Inhaled or topical corticosteroids are permitted. Short-term corticosteroid use (e.g., prior to IV contrast administration) within 2 weeks before the first dose is allowed. d. Administration of anti-cancer vaccines or live vaccines within 4 weeks prior to the first dose of the study drug. e. Major surgery or significant trauma within 4 weeks prior to the first dose of the study drug. 4.Previous discontinuation of treatment with a PD-1/PD-L1 inhibitor due to related adverse reactions. 5.Patients with active, known, or suspected autoimmune disease or immunodeficiency. Patients with vitiligo, type I diabetes mellitus, or residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy are eligible. 6.Congenital or acquired immunodeficiency, such as HIV infection, active hepatitis B (HBV DNA >= 500 IU/mL), hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay), or co-infection with HBV and HCV. 7.Serious infection (CTCAE grade >2) within 4 weeks prior to the first dose of the study drug (e.g., severe pneumonia requiring hospitalization, bacteremia, septic complications). Evidence of active pulmonary inflammation on baseline chest imaging, or signs and symptoms of infection within 2 weeks prior to the first dose requiring oral or intravenous antibiotic therapy (excluding prophylactic antibiotic use). 8.Concurrent participation in another interventional clinical study. 9.History of interstitial lung disease (ILD), drug-induced pneumonitis, or any clinically active pneumonia/ILD. 10.Pregnancy or lactation; patients of childbearing potential unwilling or unable to use effective contraception. 11.History of other prior malignancies (except for adequately treated basal cell or squamous cell skin cancer, or the following in situ cancers: bladder, gastric, colorectal, endometrial, cervical/dysplasia, melanoma, or breast cancer). 12.Known allergy, hypersensitivity, or intolerance to the study drug. 13.Any other condition deemed by the investigator to potentially compromise the patient's safety or compliance, making them unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Duration of Response;Overall survival;Progression free survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactYu Xinmin/Jin Ying
Zhejiang Cancer Hospital
Outcome results
None listed