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

Xiaorong Dong

Status and phase: Unknown; Phase 2

Conditions: Anlotinib; PD-1/L1 Inhibitor; NSCLC

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04313660

AVATAR

Details and patient eligibility

About

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

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Anlotinib In Combination With PD-1/L1 Inhibitor

Experimental group

Treatment:

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