chemo-naive incurable not highly PD-L1-expressed non-squamous non-small cell lung cancer without confirmed driver alteration
Conditions
Interventions
None listed
Sponsors
Yokohama City University University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: English-written individually randomized controlled trials for incurable NSCLC are collected. Studies focusing on patients with a driver mutation or translocation will be excluded. A conference abstract is allowed only for ICI-related treatment because we are keen to such a trial. Eligible treatments are first-line chemotherapy including cytotoxic agents, molecular targeted therapies, and immune checkpoint inhibitors. Platinum doublet counterpart had to be one of the following third-generation chemotherapy agents: Vinorelbine (Vnr), Docetaxel (Dtx), Paclitaxel (Ptx), nanoparticle albumin-bound Ptx (nabPtx), Irinotecan (Cpt11), Gemcitabine (Gem), Pemetrexed (Pemt), and Tegafur gimeracil oteracil (S1). Adding Bev on platinum regimen is accepted. Non-squamous NSCLC patients with advanced, locally advanced, or recurrent disease were included. A study focusing on patients with poor performance status or elderly should be excluded.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this analysis is overall survival (OS) evaluated with hazard ratio (HR, HRos). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactNobuyuki Horita
Yokohama City University University Hospital Chemotherapy Center
Outcome results
None listed