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

NCT ID: NCT04313660

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2022-02-28

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

Conditions

NSCLC; Anlotinib; PD-1/L1 Inhibitor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anlotinib In Combination With PD-1/L1 Inhibitor

Group Type: EXPERIMENTAL

Anlotinib In Combination With PD-1/L1 Inhibitor

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaorong Dong

OTHER

Sponsor Role: lead

Responsible Party

Xiaorong Dong

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

AVATAR

Identifier Type: -

Identifier Source: org_study_id