NCT04620837

Tislelizumab in Combination With Anlotinib With ES-SCLC as Maintenance Therapy After First Line Chemotherapy

A Prospective, Open Label, Single-arm, Phase 2 Study of Tislelizumab in Combination With Anlotinib as Maintenance Therapy in Subject With Extensive Stage Small Cell Lung Cancer （ES-SCLC） as Maintenance Therapy After First Line Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To show that maintenance therapy with Tislelizumab plus Anlotinib will prolong Progression Free Survival in subjects with extensive stage disease small cell lung cancer who have completed first line chemotherapy.

Detailed description

Most patients with extensive disease small cell lung cancer (ED-SCLC) respond to first line（1L） platinum-based chemotherapy; however, responses are not durable and prognosis is poor. Currently no maintenance treatments are approved in SCLC to prolong the durability of efficacy achieved with 1L chemotherapy. Immuno-oncology agents have demonstrated efficacy in the treatment of ED-SCLC when administered across different lines of therapy. Tislelizumab (Anti-PD-1 antibody) Combine Etoposide+ platinum （EP） had improved median Overall survival （mOS ） to 15.6m of 1L ED-SCLC in the Rationale 206 study. Anlotinib ( RTKi ) had significantly improved PFS \& OS of 3L(third line) ED-SCLC in the ALTER 1202. This phase II study is designed to explore the effect and safety of the combination as maintenance therapy for ED-SCLC after 1L chemotherapy

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab：200mg Q3W IV. There will be no dose reduction for Tislelizumab ， if there is no disease progression or serious Treatment Related adverse events(TRAE) , patients will receive Tislelizumab (200mg,Q3W) until progression or death
DRUG	Anlotinib hydrochloride	Anlotinib hydrochloride capsules: Capsule; specifications 12mg; oral, once a day, every 12mg, continuous medication two weeks after 1 week deactivated. Depending tolerated dose reduction. Medication process: disease control and patients can tolerate the side effects, continued drug use; researchers believe the patient is not fit to continue medication or efficacy evaluation at the end of the clinical progression of medication.

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-11-09
• Last updated: 2020-11-09

Locations

1 site across 1 country: China