This randomized phase II trial is to explore the clinical efficacy, safety and feasibility of neoadjuvant immunotherapy plus radiotherapy compared with neoadjuvant immunotherapy plus chemotherapy in operable stage II-IIIA (N+) non small cell lung cancer (NSCLC) and the optimal radiotherapy pattern.
Age 18 to 75 years old, gender is not limited.
ECOG performance status 0-1.
non-small cell lung cancer diagnosed by pathology.
sufficient tumor tissue available for biomarker analysis.
Pathology suggestive of compound small cell lung cancer, etc.
History of previous lobectomy, radiotherapy or chemotherapy.
Those with concurrent second primary carcinoma and a history of previous malignancy of less than 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous epithelial cell skin cancer).
Patients with any active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.).
Parallel
SBRT+LDRT
Radiationprimary tumor SBRT, DT: 24Gy/3Fx, d1-3; positive lymph nodes LDRT, DT: 3Gy/3Fx, d1-3, d22-24 (2 cycles)
Toripalimab
Drugtoripalimab 240mg ivgtt d4, d24 (2 cycles)
Chemotherapy drug
DrugNon-squamous carcinoma: pemetrexed + platinum or paclitaxel + platinum Squamous carcinoma: paclitaxel + platinum or gemcitabine + platinum
Toripalimab
Drugtoripalimab 240mg ivgtt d1, d22 (2 cycles)
Pathlogical complete remission (pCR) rate
Pathlogical complete remission rate
major pathologic response (MPR) of primary tumor
proportion of residual tumor ≤10%
Perioperative complications
complications occurring during operation
Completion of surgery
whether the surgery is completed
Rate of R0 resection
rate of participants with tumor margin negative
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Shanghai Chest Hospital
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Collaborator
