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

Phase 2

• Conditions: Anlotinib; PD-1/L1 Inhibitor; NSCLC
• Interventions: Drug: Anlotinib In Combination With PD-1/L1 Inhibitor

• Registration Number: NCT04313660
• Lead Sponsor: Xiaorong Dong

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-16
• Last Update Submitted: 2020-03-16
• Study First Posted: 2020-03-18
• Last Update Posted: 2020-03-18
• Study Start: 2020-04
• Primary Completion: 2021-02
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anlotinib In Combination With PD-1/L1 Inhibitor	Anlotinib In Combination With PD-1/L1 Inhibitor	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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