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

NCT04313660 | Unknown Phase 2 DMC

• 1 other identifier: AVATAR
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival(OS)

  1 year

Study Arms (1)

Anlotinib In Combination With PD-1/L1 Inhibitor

EXPERIMENTAL

Drug: Anlotinib In Combination With PD-1/L1 Inhibitor

Interventions

Anlotinib In Combination With PD-1/L1 Inhibitor 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.

Anlotinib In Combination With PD-1/L1 Inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xiaorong Dong: lead

MeSH Terms

Interventions

anlotinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 18, 2020
• Study Start: April 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2022
• Last Updated: March 18, 2020

Record last verified: 2020-03