Phase II study of atezolizumab for advanced non-small-cell lung cancer patients not indicative of cytotoxic chemotherapy

Phase 2

• Conditions: advanced NSCLC

• Registration Number: JPRN-UMIN000032585
• Lead Sponsor: Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-01
• Study Completion: 2021-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

1) The age of less than 20 2) Indicative for cytotoxic chemotherapy or molecular targeted agents 3) Uncontrolled brain metastasis treated by palliative radiotherapy 4) Clinically active infection 5) Severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes) 6) Uncontrolled pleural effusion 7) Active other organ cancers 8) History of severe drug allergy 9) Uncontrolled digestive ulcer 10) Any patients judged by the investigator to be unfit to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Progression-free survival, Overall survival, and Toxicity. AND, we will explore serum or blood-based biomarker analysis and immune state as the accompanying research with the informed consent