Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Atezolizumab at a fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W) Thoracic radiation therapy (TRT), 30 Gy in 10 fractions

Atezolizumab at a fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W)

fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W)

thoracic radiotherapy (TRT)

Farastuk Bozorgmehr, Dr. med.

This is a multicenter phase 2 clinical trial to investigate the treatment efficacy and feasibility of combining thoracic radiotherapy (TRT) with the IMpower133 regimen in the upfront treatment of ED SCLC patients. Patients with a response after induction therapy with carboplatin/etoposide and atezolizumab will be included into this study to subsequently receive atezolizumab maintenance therapy and will be randomized to receive TRT or not. This trial aims to i.) increase the efficacy of combined atezolizumab- and chemotherapy by adding radiotherapy and ii.) determine the safety and tolerability of the combination of chemotherapeutic, immunological and radiological treatment in the first-line setting of advanced SCLC, and iii.) to collect tumor tissue as well as blood and stool samples for separate biomarker research project.

Randomized, open label, multicenter, phase II trial

Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease

Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease: a Randomized, Open-label, Multicenter Phase II Study

Collection of biomarker samples for separate biomarker research project

OS rate after 2 years after randomization

PFS is defined as time from randomization to the date of first observed disease progression (investigator assessment according to RECIST 1.1) or death from any cause

ORR will be assessed according to RECIST 1.1. The objective response rate will be defined as the proportion of allocated / randomized subjects with best response of complete or partial response.

rate of intrathoracic progression will be determined via assessing the proportion of allocated / randomized subjects with an intrathoracic progression (investigator assessment according to RECIST 1.1).

Incidence, nature, causal relationship and severity of Adverse Events according to CTC v5.0

Frequency of abnormal laboratory parameters

description of relative and absolute frequencies of treatment withdrawal (either due to adverse events or other reasons), which will be compared between treatment groups

relative and absolute numbers of radiotherapy completers

Cancer-related quality of life measured via the total- and subscores of FACT-L will be compared between the two treatments by analyzing the mean change from baseline. Score scales are ranging from 0 (minimum) to 4 (maximum).

Spots Global Cancer Trial Database for thoracic radiotherapy (trt)