The Effect of Toripalimab Plus Radiotherapy in Patients With Operable Stage II-IIIA (N+) Non Small Cell Lung Cancer

ConditionNSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Chest Hospital

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

124 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Chest Hospital

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Collaborator