NSCLC
Conditions
Interventions
Case series:treated with PD-1/PD-L1 inhibitors
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The estimated enrollment is 250 participants. Enrollment was limited to patients: 1. Aged 18 to 75 years; 2. With histologically or cytologically confirmed metastatic or local advanced NSCLC;Without any EGFR or ALK genetic alteration (common or uncommon); 3. Engaged in the treatment of anti-PD-1/PD-L1 antibodies or combined with other drugs; 4. With available tumor tissue samples within two years before treatment or engaged in biopsies, no less than 15 pieces of FFPE samples; 5. With available peripheral blood samples obtained within one week before treatment, six weeks later after treatment, and at the time point of withdrawal, 10ml each sample; 6. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST); 7. Eastern Cooperative Oncology Group performance status of 0 or 1; 8. Life expectance of at least 12 weeks; 9. With adequate organ function and hematopoiesis.
Exclusion criteria
Exclusion criteria: 1. Subjects who need to receive systemic corticosteroid (equivalent to or higher than 10mg/ day prednisone) or other immunosuppressive drugs within 14 days before enrollment or during the study period; 2. Those who have received anti-tumor vaccine, or those who have received anti-tumor drug therapy with immune-stimulating effect within 4 weeks before enrollment; 3. Patients with other malignant tumors within 5 years before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;PFS; | — |
Countries
China
Contacts
Public ContactChunxue Bai,Qunying Hong
Zhongshan Hospital Fudan University
Outcome results
None listed