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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04313660
• Other study ID #: AVATAR
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2020
• Est. completion date: February 2022

Study information

• Verified date: March 2020
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: February 2022
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anlotinib
• NSCLC
• PD-1/L1 Inhibitor
• Small Cell Lung Carcinoma

Intervention

Drug:
• Anlotinib 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiaorong Dong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progress free survival(PFS)	the period from the beginning of treatment to the observation of disease progress or death for any reason	1 year
Secondary	Overall survival(OS)	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	1 year