Unique ID issued by UMIN | UMIN000042163 |
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Receipt number | 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 | 2021/12/20 12:46:04 |
Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Network meta-analysis for chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Japan |
chemo-naive incurable not highly PD-L1-expressed squamous non-small cell lung cancer without confirmed driver alteration
Pneumology |
Malignancy
NO
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.
Safety,Efficacy
The primary outcome of this analysis is overall survival (OS) evaluated with hazard ratio (HR, HRos).
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.
Others,meta-analysis etc
Not applicable |
Not applicable |
Male and Female
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.
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.
1st name | Nobuyuki |
Middle name | |
Last name | Horita |
Yokohama City University University Hospital
Chemotherapy Center
236-0004
3-9, fukuura, Kanazawa, Yokohama, Japan
0457872700
horitano@yokohama-cu.ac.jp
1st name | Nobuyuki |
Middle name | |
Last name | Horita |
Yokohama City University University Hospital
Chemotherapy Center
236-0004
3-9, fukuura, Kanazawa, Yokohama, Japan
0457872700
horitano@yokohama-cu.ac.jp
Yokohama City University University Hospital
Yokohama City University University Hospital
Other
Yokohama City University University Hospital
3-9, fukuura, Kanazawa, Yokohama, Japan
0457872800
horitano@yokohama-cu.ac.jp
NO
2020 | Year | 10 | Month | 20 | Day |
Unpublished
22619
Please see:
Transl Lung Cancer Res. 2021 Aug;10(8):3550-3566. doi: 10.21037/tlcr-21-419.
2021 | Year | 12 | Month | 20 | Day |
Please see:
Transl Lung Cancer Res. 2021 Aug;10(8):3550-3566. doi: 10.21037/tlcr-21-419.
Please see:
Transl Lung Cancer Res. 2021 Aug;10(8):3550-3566. doi: 10.21037/tlcr-21-419.
Please see:
Transl Lung Cancer Res. 2021 Aug;10(8):3550-3566. doi: 10.21037/tlcr-21-419.
Please see:
Transl Lung Cancer Res. 2021 Aug;10(8):3550-3566. doi: 10.21037/tlcr-21-419.
Please see:
Transl Lung Cancer Res. 2021 Aug;10(8):3550-3566. doi: 10.21037/tlcr-21-419.
Please see:
Transl Lung Cancer Res. 2021 Aug;10(8):3550-3566. doi: 10.21037/tlcr-21-419.
Please see:
Transl Lung Cancer Res. 2021 Aug;10(8):3550-3566. doi: 10.21037/tlcr-21-419.
Main results already published
2020 | Year | 10 | Month | 20 | Day |
2020 | Year | 10 | Month | 20 | Day |
2020 | Year | 10 | Month | 20 | Day |
2021 | Year | 10 | Month | 20 | Day |
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
2020 | Year | 10 | Month | 19 | Day |
2021 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048129
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