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

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

Study Overview

• Status: Unknown
• Conditions: NSCLC; Anlotinib; PD-1/L1 Inhibitor
• Intervention / Treatment: Drug: Anlotinib In Combination With PD-1/L1 Inhibitor

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xiaorong Dong

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2020
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): February 1, 2022

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (ACTUAL): March 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: AVATAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No