NSCLC
Conditions
Interventions
single arm:PD-1 monoantibody and chemotherapy
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Histologically or cytologically confirmed NSCLC that is locally advanced and unresectable; 3. Driver gene detection is negetive for EGFR sensitive mutation or ALK fusion or ROS1 gene fusion; 4. Histological specimen PD-L1 >= 1%; 5. Subject has not received any treatment for NSCLC; 6. Measurable disease (according to RECIST v1.1 criteria); 7. ECOG Performance Status 0~1;Life expectancy >= 12 weeks; 8. Adequate haematological function; 9. Women of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication; Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 180 days after the last dose of study therapy; 10. Written Informed Consent (IC) for trial treatment must be signed and dated by the patient and the investigator prior to any trial-related evaluation and/or intervention.
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed SCLC; 2. With a history of other primary tumorsHistory of allogeneic organ transplantation; 3. Major surgery except diagnostic biopsy within 4 weeks before first medication; 4. Uncontrolled hypertensionUncontrolled arrhythmiaSymptomatic congestive heart failurewith unstable angina or new anginaActive interstitial lung diseaseSevere gastrointestinal disease with diarrheaActive infections (including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus); 5. Have an active, or have had an autoimmune disease that may recur; 6. Currently receiving systemic hormonal therapy (eg equivalent to> 10 mg of prednisone per day, or any other form of immunosuppressive therapy used within 14 days prior to the first dose); 7. Prior therapy with any other antibody targeting T cell co-regulatory pathways (PD-1PD-L1CTLA4TIM3LAG3); 8. Subjects with a history of interstitial lung diseaseOr have a previous history of interstitial lung disease and need hormone therapy; 9. Subjects with previous history of idiopathic pulmonary fibrosis (IPF), drug-induced pneumonia, organizing pneumonia (such as occlusive bronchiolitis), idiopathic pneumonia; or screening chest CT with active pneumonia; 10. Inoculate a live attenuated vaccine within 4 weeks prior to the first dose or during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Overall survival (OS);quality of life; | — |
Countries
China
Contacts
Public ContactYaping Xu
Shanghai Pulmonary Hospital
Outcome results
None listed