SCLC
Conditions
Interventions
No previous immunotherapy: Donafenib Combined with Toripalimab
Previous immunotherapy: Donafenib Combined with Toripalimab
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary entry and signed written informed consent; 2. Age 18~80 years old (including 80 years old), male or female; 3. Histologically or cytologically proven small cell lung cancer (SCLC); 4. Extensive Stage Small Cell Lung Cancer (ED-SCLC) according to Veterans Administration Lung Study Group (VALG); 5. Progress after receiving the first-line platinum-containing chemotherapy regimen confirmed by imaging; 6. According to the efficacy evaluation criteria for solid tumors (RECIST version 1.1), at least one lesion is radiologically measurable. A lesion located in the previous radiotherapy field can be considered as a measurable lesion if it is proved to have progressed. 7. ECOG PS 0-1; 8. Expected survival time of > 3 months; 9. Women who are fertile (pre-menopausal or not surgically sterilized) must have a negative serological pregnancy test within 7 days prior to study drug administration; 10. Fertile female or male patients must use reliable contraceptives during study drug use and for 60 days after the last drug use; 11. Major organs function normally. 2) 18~80 years old (including 80 years old), no gender limit; 3) Small cell lung cancer (SCLC) confirmed by histology or cytology; 4) According to the Veterans Administration Lung Study Group (VALG) staging, it is classified as extensive-stage small cell lung cancer (ED-SCLC); 5) Progression confirmed by imaging studies after receiving first-line platinum-containing chemotherapy; 6) According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there is at least one imaging measurable lesion. The lesions located in the radiation field of the previous radiotherapy can be regarded as measurable lesions if the progress is confirmed; 7) The Eastern Cooperative Oncology Group (ECOG) physical performance (PS) score is 0~1;
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed mixed SCLC and NSCLC; 2. Clinically symptomatic central nervous system metastases and/or cancerous meningitis with a history of pneumomeningeal carcinoma; 3. Radiation therapy prior to drug administration in the first study; 4. Suffering from other malignant tumors; 5. Prior or current congenital or acquired immunodeficiency disease; 6. Active or previously recorded autoimmune or inflammatory diseases; 7. Previous history of serious mental illness; 8. Suffering from diseases that affect the absorption, distribution, metabolism or elimination of the study drugs (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.); 9. Underwent major surgery (as defined by the investigator) within 4 weeks prior to enrolment, or expected to require major surgery during study treatment; 10. Previous recipient of allogeneic stem cell or solid organ transplantation; 11. Previously received targeted therapy drugs containing VEGF, including but not limited to amrotinib, apatinib, bevacizumab, etc.;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Progression Free Survival, PFS;Duration of Remission, DOR;Disease Control Rate, DCR;Safety; | — |
Countries
China
Contacts
Public ContactHu Yi
Chinese PLA General Hospital
Outcome results
None listed