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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042163
Receipt No. R000048129
Scientific Title Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Date of disclosure of the study information 2020/10/20
Last modified on 2020/10/19

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Basic information
Public title Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Acronym Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Scientific Title Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Scientific Title:Acronym Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Region
Japan

Condition
Condition chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Several regimens combining ICI and cytotoxic drugs are recommended even for a patient with low or negative PD-L1 score since they greatly improved objective response rate (ORR), progression-free survival (PFS), and even overall survival (OS) of patients with low-/negative-PD-L1 expressed NSCLC without substantially increasing a risk of adverse event compared to reference platinum regimens without ICI. However, few RCTs have directly compared ICI regimens because such a trial demands a large number of subjects to reveal small outcome difference. Nonetheless, oncologists still earn to know rank order regarding efficacy and safety endpoints among ICI regimens because it is key to select treatment for a real patient. A network-meta-analysis is the best analytical technique to enable indirect comparison among numerous regimens. Our previous network meta-analysis published in 2017 evaluated only non-ICI non-kinase-inhibitor regimens for chemo-naive incurable NSCLC. Aim of the current study, focusing on ICI regimens and negative- or low-PD-L1 expressed squamous NSCLC cases without driver alteration, is to update the previous network meta-analysis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome of this analysis is overall survival (OS) evaluated with hazard ratio (HR, HRos).
Key secondary outcomes 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.

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key 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), and Tegafur gimeracil oteracil (S1). Necitumumab (Nctm), EGFR monoclonal antibody, plus platinum regimens for squamous carcinoma is acceptable.
Squamous NSCLC patients with advanced, locally advanced, or recurrent disease were included.
Key exclusion criteria Kinase inhibitors targeting EGFR, ALK, ROS1, and BRAF are beyond our concern.
A study focusing on patients with poor performance status or elderly should be excluded.
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 non-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.
Target sample size

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Horita
Organization Yokohama City University University Hospital
Division name Chemotherapy Center
Zip code 236-0004
Address 3-9, fukuura, Kanazawa, Yokohama, Japan
TEL 0457872700
Email horitano@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Horita
Organization Yokohama City University University Hospital
Division name Chemotherapy Center
Zip code 236-0004
Address 3-9, fukuura, Kanazawa, Yokohama, Japan
TEL 0457872700
Homepage URL
Email horitano@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University University Hospital
Institute
Department

Funding Source
Organization Yokohama City University University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama City University University Hospital
Address 3-9, fukuura, Kanazawa, Yokohama, Japan
Tel 0457872800
Email horitano@yokohama-cu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 20 Day
Last follow-up date
2021 Year 10 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information MEDLINE, EMBASE, the Web of Science Core Collection, and the Cochrane Central Register of Controlled Trials will be searched to identify eligible articles. The following formula will be used for MEDLINE: (non-small OR squamous OR adenocarcinoma OR non-squamous OR NSCLC) AND (lung cancer OR lung carcinoma OR lung malignancy OR lung tumor OR NSCLC) AND (advanced OR metastasis OR recurrent OR recurrence OR inoperable OR relapsed OR incurable OR stage 3 OR stage 3a OR stage 3b OR stage III OR stage IIIa OR stage IIIb OR stage 4 OR stage 4a OR stage 4b OR stage IV OR stage IVa OR stage IVb) AND (naive OR untreated OR chemo naive OR chemo-naive OR non-treated OR nontreated OR first-line OR front-line OR initial treatment OR "previously not treated") AND (randomized[title] OR randomised[title] OR randomly OR phase 3[title] OR phase III[title] OR RCT[title] OR (nejm AND (randomized OR randomised OR randomly OR phase 3 OR phase III OR RCT))).
Treatment arm will be named based on the drug combination regardless of dose, route, and schedule. Maintenance therapy and later-line therapy will be ignored to decide treatment arm. We will categorize Cddp, Cbdca, and "selective administration of Cddp and Cbdca" as a platinum (Plt), otherwise RCTs that allows selective Cddp/Cbdca for both arms cannot be assessed comprehensively in a network loop. Both Ptx and nab-Ptx will be regarded as Ptx for the same reason. We will obtain data of a subgroup by subtraction using fixed-model meta-analysis formula. For example, subtracting data of "PD-L1=>50%" subgroup from data of whole population yields data of "PD-L1<50%" subgroup.
The frequentist weighted least squares approach random-model network meta-analysis will be applied for our study

Management information
Registered date
2020 Year 10 Month 19 Day
Last modified on
2020 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048129

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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