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試験進捗状況 開始前/Preinitiation
UMIN試験ID UMIN000042163
受付番号 R000048129
科学的試験名 PD-L1非高発現でドライバー変異を伴わない抗癌剤未治療進行扁平上皮非小細胞肺癌治療に関するネットワークメタアナリシス
一般公開日(本登録希望日) 2020/10/20
最終更新日 2020/10/19

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title PD-L1非高発現でドライバー変異を伴わない抗癌剤未治療進行扁平上皮非小細胞肺癌治療に関するネットワークメタアナリシス Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
一般向け試験名略称/Acronym PD-L1非高発現でドライバー変異を伴わない抗癌剤未治療進行扁平上皮非小細胞肺癌治療に関するネットワークメタアナリシス Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
科学的試験名/Scientific Title PD-L1非高発現でドライバー変異を伴わない抗癌剤未治療進行扁平上皮非小細胞肺癌治療に関するネットワークメタアナリシス Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
科学的試験名略称/Scientific Title:Acronym PD-L1非高発現でドライバー変異を伴わない抗癌剤未治療進行扁平上皮非小細胞肺癌治療に関するネットワークメタアナリシス Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 扁平上皮肺癌 chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
疾患区分1/Classification by specialty
呼吸器内科学/Pneumology
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 英文参照のこと 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.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes 全生存期間 The primary outcome of this analysis is overall survival (OS) evaluated with hazard ratio (HR, HRos).
副次アウトカム評価項目/Key secondary outcomes 無増悪生存期間、奏効率、副作用(G3-)、治療関連死亡 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.

基本事項/Base
試験の種類/Study type その他・メタアナリシス等/Others,meta-analysis etc

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit

適用なし/Not applicable
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria 英文参照 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.
除外基準/Key exclusion criteria 英文参照 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.
目標参加者数/Target sample size

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
堀田
ミドルネーム
信之
Nobuyuki
ミドルネーム
Horita
所属組織/Organization 横浜市立大学附属病院 Yokohama City University University Hospital
所属部署/Division name 化学療法センター Chemotherapy Center
郵便番号/Zip code 236-0004
住所/Address 横浜市金沢区福浦3-9 3-9, fukuura, Kanazawa, Yokohama, Japan
電話/TEL 0457872700
Email/Email horitano@yokohama-cu.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
堀田
ミドルネーム
信之
Nobuyuki
ミドルネーム
Horita
組織名/Organization 横浜市立大学附属病院 Yokohama City University University Hospital
部署名/Division name 化学療法センター Chemotherapy Center
郵便番号/Zip code 236-0004
住所/Address 横浜市金沢区福浦3-9 3-9, fukuura, Kanazawa, Yokohama, Japan
電話/TEL 0457872700
試験のホームページURL/Homepage URL
Email/Email horitano@yokohama-cu.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Yokohama City University University Hospital
機関名/Institute
(機関選択不可の場合)
横浜市立大学附属病院
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Yokohama City University University Hospital
機関名/Organization
(機関選択不可の場合)
横浜市立大学附属病院
組織名/Division
組織の区分/Category of Funding Organization その他/Other
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 横浜市立大学附属病院 Yokohama City University University Hospital
住所/Address 横浜市金沢区福浦3-9 3-9, fukuura, Kanazawa, Yokohama, Japan
電話/Tel 0457872800
Email/Email horitano@yokohama-cu.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2020 10 20

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 開始前/Preinitiation
プロトコル確定日/Date of protocol fixation
2020 10 20
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2020 10 20
フォロー終了(予定)日/Last follow-up date
2021 10 20
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information 英文参照 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

管理情報/Management information
登録日時/Registered date
2020 10 19
最終更新日/Last modified on
2020 10 19


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048129
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048129

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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