Anlotinib, NSCLC, PD-1/L1 Inhibitor
Conditions
Brief summary
Anlotinib In Combination With PD-1/L1 Inhibitor As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study
Interventions
DRUGAnlotinib In Combination With PD-1/L1 Inhibitor
At the end of chest radiotherapy (c2d1), the simultaneous administration of androtinib hydrochloride capsule and PD-1 / L1 inhibitor was started. L Arotinib hydrochloride capsule, 12 mg, Po, QD, was taken orally for two weeks, one week, three weeks as a cycle, completed in the first 14 days until the disease progress; Durvalumab injection, 1500mg, IV, once every three weeks, completed on the first day until the disease progresses. Tetraprizumab injection, 240mg, IV, once every three weeks, completed on the first day until the disease progresses. The choice of durvalumab / trepril mAb was at the discretion of the researchers.
Sponsors
Xiaorong Dong
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 subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up; 2. Patients between 18-75 years old; 3. Extensive small cell lung cancer confirmed by histopathology (according to Veterans Administration lung study group, Valg stage) and did not progress after 4-6 cycles (21 days as a cycle) of first-line standard chemotherapy platinum combined with etoposide \[complete remission (CR), partial remission (PR) or stable (SD) according to recist1.1 standard\]; 4. The time interval between the first TRT and the end of the last chemotherapy should be less than or equal to 6 weeks; 5. The life expectancy shall be at least 3 months; 6. ECoG score: 0-1
Exclusion criteria
1. Small cell lung cancer patients with other pathological types of tumor species; 2. Patients with pathological fracture in bone metastasis of small cell lung cancer; 3. Patients with central nervous system metastasis; 4. Patients who have received chest radiotherapy before; 5. Patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before; 6. Imaging (CT or MRI) showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a central tumor invading the local large blood vessel, or there was an obvious cavitary or necrotic tumor in the lung;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progress free survival(PFS) | 1 year | the period from the beginning of treatment to the observation of disease progress or death for any reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival(OS) | 1 year | Time from randomization to death for any reason. The last follow-up time is usually calculated as the time of death for the subjects who have lost the visit before death |
Outcome results
None listed