Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study

Sponsor

Wuhan Union Hospital, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT04314297

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study

Condition or Disease	Intervention/Treatment	Phase
Anlotinib Durvalumab Small Cell Lung Cancer	Drug: Anlotinib In Combination With Durvalumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Feb 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anlotinib In Combination With Durvalumab	Drug: Anlotinib In Combination With Durvalumab 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.

Arm

Intervention/Treatment

Experimental: Anlotinib In Combination With Durvalumab

Drug: Anlotinib In Combination With Durvalumab

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up; Patients between 18-75 years old; 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]; The time interval between the first TRT and the end of the last chemotherapy should be less than or equal to 6 weeks; The life expectancy shall be at least 3 months; ECoG score: 0-1

Exclusion Criteria:

Small cell lung cancer patients with other pathological types of tumor species; Patients with pathological fracture in bone metastasis of small cell lung cancer; Patients with central nervous system metastasis; Patients who have received chest radiotherapy before; Patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before; 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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaorong Dong, Professor, Wuhan Union Hospital, China

ClinicalTrials.gov Identifier:

NCT04314297

Other Study ID Numbers:

AVATAR 2

First Posted:

Mar 19, 2020

Last Update Posted:

Mar 19, 2020

Last Verified:

Mar 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Durvalumab

Study Results

No Results Posted as of Mar 19, 2020