NCT04636762

A Study of Concurrent Chemoradiation With Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

A Multi-center, Single Arm , Phase II Study of Atezolizumab Combined With Concurrent Chemoradiotherapy and Maintenance Therapy With Atezolizumab in Untreated Participants With Extensive-stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Etoposide-cisplatin/ -carboplatin in combination with PD-L1 inhibitor for 4 cycles followed by maintenance therapy with PD-L1 inhibitor is currently the world-wide first-line treatment for extensive-stage small cell lung cancer. When 4 cycles of EC/EP chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy. In our study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC/EP chemotherapy plus Atezolizumab, participants with response（PR/CR/SD）will receive concurrent radiotherapy and 2 cycles of EC/EP chemotherapy plus Atezolizumab, then maintenance therapy with Atezolizumab （Q3W）. The purpose of this study is to explore the safety and efficacy of Atezolizumab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.

Detailed description

participants receive EC/EP chemotherapy combined with Atezolizumab for 2 cycles, and the efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy comined with EC/EP(2 cycles) +Atezolizumab will be initiated. After concurrent chemoradiotherapy +Atezolizumab, Atezolizumab was maintained until PD or intolerance or for at most 2 years. participants with brain metastases will receive radiotherapy for brain metastases during the first 2 cycles of chemotherapy.

Conditions

• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Radiation Therapy	Thoracic Radiation Dose: 3Gy, QD, total dose: 30-45Gy; Particpants with brain metastases：metastatic lesions≤3:whole brain radiotherapy with local simultaneous PGTV:50Gy/10F；metastatic lesions\>3:whole brain radiotherapy PTV:30Gy/10F.

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2020-11-19
• Last updated: 2022-06-14

Locations

2 sites across 1 country: China