non-small cell lung cancer
Conditions
Interventions
Treatment group :Inductive immunotherapy followed by radiotherapy and consolidative immunotheray
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Sign and date the ICF, prior to the start of any study-specific qualification procedures; 2. Aged 18-80 years (not including 80), at the time of informed consent; 3. Histologically documented unresectable locally advanced (stage III, AJCC 8) NSCLC, excluding EGFR sensitive mutation or ALK rearrangement; 4. ECOG PS of 0-1; 5. Has a life expectancy of at least 12 weeks; 6. At least one measurable disease using RECIST V1.1; 7. Adequate organ function; 8. The childbearing potential male and female subjects must be willing to use highly effective birth control procedures during the Treatment Period, until 180 days following the last dose of treatment.
Exclusion criteria
Exclusion criteria: 1. Histologically documented mixed small cell lung cancer; 2. Has received prior systemic anti-cancer treatment; 3. Has received prior anti-cancer Chinese traditional medicine, or immune-modulating treatment within 14 days before the first dose of study drug; 4. Has received prior radiotherapy to the lung; 5. Active, or known autoimmune disease; 6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (over 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study drug; 7. Has symptomatic interstitial lung disease; 8. History of tuberculosis infection within 1 year; 9. Has HIV infection, active hepatitis B (HBsAg positive and HBV-DNA over 500 cps/ml), or hepatitis C (HCV-Ab positive); 10. Has an active infection requiring systemic treatment within 14 days; 11. Had an allogeneic tissue/solid organ transplant; 12. Any other medical conditions, including but not limited to symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, active peptic ulcer, or blooding disease; 13. History of another primary malignancy (beyond NSCLC) within 5 years before the first dose of study drug; 14. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study drug; 15. Concurrent participation in another therapeutic clinical study; 16. Other underlying medical conditions that might impair compliance with study conduct.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Countries
China
Contacts
Public ContactMin Tang
Beijing Hospital
Outcome results
None listed