etwork meta-analysis for chemo-naive incurable not highly PD-L1-expressed non-squamous non-small cell lung cancer without confirmed driver alteratio

Not Applicable

• Conditions: chemo-naive incurable not highly PD-L1-expressed non-squamous non-small cell lung cancer without confirmed driver alteration

• Registration Number: JPRN-UMIN000042164
• Lead Sponsor: Yokohama City University University Hospital

Brief Summary

Please see: Thorac Cancer. 2021 Nov 17. doi: 10.1111/1759-7714.14229.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-20
• Study Completion: 2020-10-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 16391

Inclusion Criteria

Not provided

Exclusion Criteria

Kinase inhibitors targeting EGFR, ALK, ROS1, and BRAF are beyond our concern. A patient whose PD-L1 protein expression determined by tumor proportion score (TPS) is 50% or higher will be excluded because current guidelines recommends treatment option differently for those with TPS <50% and >=50%. If subset of study population fit our criteria, the data of the subset will be analyzed. For example, a study separately provide data of three populations whose TPS score is 0%, 1-49%, and 50-%, we will collect data of populations with TPS of 0% and 1-49%. Tumor mutation burden is not questioned. If a study focusses on patients with squamous NSCLC, driver alteration, or TPS of 50% or higher, the study should be excluded. However, a study without criteria regarding pathological subclassification of NSCLC, driver gene, and TPS is acceptable, otherwise most NSCLC studies will be excluded.

Study & Design

• Study Type: Others,meta-analysis etc
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this analysis is overall survival (OS) evaluated with hazard ratio (HR, HRos).

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are HR for progression-free survival (PFS, HRpfs), odds ratio (OR) of objective response rate (ORrr), OR of adverse event with Common Terminology Criteria for Adverse Events grade III or higher (ORae) , and OR of treatment related death (ORtrd). Disease progression and objective RR should be assessed in compliance with the Response Evaluation Criteria In the Solid Tumors guidelines published in 2000 or its 2009 revision. Imaging evaluation that was done by the blinded independent central reviewing is preferred, if available. The first adverse event with grade III or higher will be counted even if a patient experienced adverse event twice or more.