Lung cancer
Conditions
Interventions
test group:Adjuvant chemotherapy period:
Cisplatin/carboplatin + vincristine/paclitaxel/docetaxel/pemetrexed (non-squamous)/gemcitabine, 1-4 cycles.
Immunoadjuvant therapy period:
QL1706, 5 mg/kg, i.v
Sponsors
Nantong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old, both male and female; 2. histologically or cytologically confirmed stage IB (tumor = 4 cm) - stage IIIA (T2-3N0, T1-3N1, T1-3N2) NSCLC (AJCC 8th edition); 3. subject persons must have completed complete resection of NSCLC 6-12 weeks (= 42 days and = 84 days) prior to enrollment and must have recovered adequately from the procedure. The type of resection accepted includes any of the following: lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy. Segmental resections or wedge resections are not permitted. 4.Subjects will be required to undergo complete mediastinal lymph node dissection (MLND). If mediastinoscopy is not performed preoperatively, systematic sampling of the mediastinal lymph nodes is required at a minimum. Systematic sampling is defined as the removal of at least one representative lymph node at specified levels.MLND requires the removal of all lymph nodes at these same levels. Sampling or MLND was required in zones 4 and 7 for right-sided open-heart surgery and in zones 5 and/or 6 and 7 for left-sided open-heart surgery.An exception was made if the surgeon clearly documented in the operative report or in a separately submitted appendix that the required lymph node areas were explored; if no lymph nodes were found in these areas, the participant was considered eligible; If the participant has a documented N2 lesion at one level, all levels need not be sampled; if the preoperative staging imaging results (contrast computed tomography [CT] and positron emission tomography [PET] scans) do not show evidence of disease in the mediastinum, N2 node sampling will not be performed at the discretion of the surgeon, and the participant will be considered eligible. 5. Subjects can receive a chemotherapy regimen of cisplatin/carboplatin + vincristine/paclitaxel/docetaxel/pemetrexed (non-squamous)/gemcitabine 6. Life expectancy is more than 3 months; 7. ECOG physical status score of 0 to 1; 8. women of childbearing potential must have a negative serum pregnancy study within 7 days prior to first dose. Female subjects of childbearing potential and male subjects whose partner is a woman of childbearing potential must agree to contraception from the time of signing the informed consent until 24 weeks after the last administration of study drug; 9. Prior to chemotherapy, the laboratory test values meet the following conditions: (1) blood routine (no blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening): white blood cell (WBC) = 3.0 × 109/L; absolute neutrophil count (ANC) = 1.5 × 109/L; platelet (PLT) = 100 × 109/L; hemoglobin (HGB) = 9.0 g/dL; and the hemoglobin level (HGB) = 1.0 g/dL. 1.5 × 109/L; platelet (PLT) = 100 × 109/L; hemoglobin (HGB) = 9.0 g/dL; (2) Liver function: aspartate transferase (AST) = 2.5 x ULN in subjects without liver metastases; alanine aminotransferase (ALT) = 2.5 x ULN, ALT, AST = 5 x ULN in subjects with liver metastases; serum total bilirubin (TBIL) = 1.5 x ULN (except for Gilbert's syndrome, where total bilirubin is = 3.0 mg/dL). (3) Renal function: serum creatinine = 1.5 x ULN or creatinine clearance rate (CrCl) = 50 mL/minute; (4) Coagulation function: international normalized ratio (INR) = 1.5 x ULN, activation of the blood clotting function (CCT) = 1.5 x ULN. (4) Coagulation function: international normalized ratio (INR) = 1.5 x ULN, activated partial thromboplastin time (APTT) = 1.5 x ULN (only for patients
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women; 2. previous systemic chemotherapy; 3. previous hormonal cancer therapy or radiation therapy within 5 years prior to enrollment (Surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy more than 5 years prior to enrollment that is currently considered cured is acceptable. Current use of hormone replacement therapy or oral contraceptives is permitted). ; 4. patients who are hearing impaired; 5. known hypersensitivity to any component of the chemotherapy regimen or mannitol that the patient will receive; 6. interstitial lung disease or a history of pneumonia; 7. malignancy other than NSCLC that has occurred within 5 years prior to enrollment, except for those who have had a negligible risk of metastasis or death (e.g., expected 5-year survival greater than 90%) and who have been treated to achieve the expected cure (e.g., adequately treated cervical carcinoma in situ, basal cell or squamous cell skin carcinoma, localized prostate carcinoma treated surgically to achieve cure, and catheter carcinoma in situ treated surgically to achieve cure) . 8. active, known or suspected autoimmune disease including, but not limited to, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus rheumatoid arthritis, and inflammatory bowel disease. Enrollment is allowed for type I diabetes mellitus (glycemic control with insulin therapy), residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or lack of exogenous stimuli that are not expected to recur; patients with eczema, psoriasis, chronic lichen simplex moss, or vitiligo dermatologic manifestations only (psoriatic arthritis needs to be ruled out) may be enrolled if the rash cover less than 10% of the body surface area, have adequately controlled disease at baseline and require only low-potency topical steroid therapy, and have not had an acute exacerbation of the underlying disease in the past 12 months (no need for psoralens plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologics, oral calmodulin phosphatase inhibitors, high potency, or oral steroids) may be enrolled in the study; 9. prior treatment with any T-cell co-stimulation or immune checkpoint therapy, including, but not limited to, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other agents that target T cells; 10. HBsAg positivity with HBV DNA copy number greater than the upper limit of normal (1000 copies/ml or 500 IU/ml) in the laboratory section of the research center, or HCV positivity (HCV RNA or HCV Ab test suggestive of acute or chronic infection); known history of HIV-positive disease or known Acquired Immune Deficiency Syndrome (AIDS); 11. history of idiopathic pulmonary fibrosis, organic pneumonia (e.g., occlusive bronchiectasis), drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or active pneumonitis with clinical symptoms; or other moderately-severe lung disease that severely affects lung function (patients with a history of radiation pneumonitis (fibrosis) present in the radiation area may be eligible for this study) 12. active tuberculosis (TB) or subjects with a history of active TB infection, treated or untreated, within = 48 weeks prior to screening; 13. the presence of severe infections including, but not limited to, complications of infections requiring hospitalization, bacteremia, severe pneumonia, etc; 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival in the ITT population;DFS in the PD-L1 TC =50% population;3- and 5-year DFS rates;security; | — |
Countries
China
Contacts
Public ContactXiaodong Zhang
Nantong Cancer Hospital
Outcome results
None listed