About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.).
Trial design
Treatments tested in this trial
- SBRT+LDRT
- Toripalimab
- Chemotherapy drug
- Toripalimab
Treatment groups
Sponsors and collaborators
Shanghai Chest Hospital
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Collaborator