Limited-stage Small Cell Lung Cancer, LS-SCLC
Conditions
Brief summary
SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy
Interventions
DRUGSHR-1316
Anti-PD-L1 antibody，Maintenance therapy, The drug was administered every three weeks
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The age is 18-75 years old (including both ends), regardless of gender; 2. Histologically confirmed limited stage small cell lung cancer ; 3. ECOG PS 0 \ 1; 4. Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication. 5. The last chemotherapy must be finished before or at the same time of radiotherapy. 6. The disease did not progress after concurrent chemoradiotherapy; 7. The expected survival time was more than 3 months; 8. Pulmonary function: FEV1 \> 70%;
Exclusion criteria
1. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up. 2. Mixed SCLC or NSCLC confirmed by histology; 3. Locally advanced small cell lung cancer receiving sequential chemoradiotherapy; 4. Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC; 5. Extensive SCLC; 6. Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery); 7. Interstitial pneumonia 8. History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. 9. HIV, active Hepatitis B or Hepatitis C infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Up to approximately 24 months | progression-free survival |
Contacts
Primary ContactXiaorong Dong, PhD
Outcome results
None listed