UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054659 |
|---|---|
| Receipt number | R000062459 |
| Scientific Title | Immune checkpoint inhibitors for neoadjuvant chemotherapy for resectable non-small cell lung cancer: a systematic review and network meta-analysis |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2024/06/13 17:50:41 |
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Basic information
Public title
Immune checkpoint inhibitors for neoadjuvant chemotherapy for resectable non-small cell lung cancer: a systematic review and network meta-analysis
Acronym
Immune checkpoint inhibitors for neoadjuvant chemotherapy for resectable non-small cell lung cancer: a systematic review and network meta-analysis
Scientific Title
Immune checkpoint inhibitors for neoadjuvant chemotherapy for resectable non-small cell lung cancer: a systematic review and network meta-analysis
Scientific Title:Acronym
Immune checkpoint inhibitors for neoadjuvant chemotherapy for resectable non-small cell lung cancer: a systematic review and network meta-analysis
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The PEARLS/KEYNOTE-091 trial and IMpower010 trial were conducted to assess standalone AC treatments without NAC. Despite being limited to patients with positive programmed death-ligand 1 (PD-L1) expression, these studies did not show significant improvement in overall survival (OS). On the other hand, several clinical studies reporting on standalone NAC or combined NAC and AC incorporating ICI have shown substantial improvements in OS. A recent meta-analysis by Sorin et al. demonstrated that neoadjuvant chemoimmunotherapy was superior to neoadjuvant chemotherapy across surgical, pathological, and efficacy outcomes. A major concern for clinicians is identifying the specific best regimen within NAC with ICIs. The purpose of this systematic review is to compare the different regimens of NAC and combined NAC and AC through a network meta-analysis, examining their effectiveness and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The co-primary outcomes of this analysis will be the hazard ratio (HR) for overall survival (HRos) and, the HR for event-free survival (EFS, HRefs). Although progression-free survival (PFS), recurrence-free survival (RFS), and disease-free survival (DFS) are not identical to EFS, these outcomes will be analyzed collectively due to their conceptual similarity, especially for patients with successful surgical removal.
Additionally, the odds ratio (OR) for surgical resection rate, complete surgical removal of a tumor with no visible or microscopic cancer cells left at the margins of the resected tissue (R0 resection), major pathological response (MPR), any grade treatment-related adverse event (any TRAE), grade 3 or higher TRAE (>= G3 TRAE), grade 5 AE, serious AE, and AE leading to surgery cancellation will also be analyzed.
Key secondary outcomes
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
Inclusion Criteria, Publication Type, and Trial Design
We focus on patient-level randomized controlled trials (RCTs) for early-stage and locally-advanced NSCLC. Trials that recruit patients with driver mutations or translocations will be excluded, whereas those with driver negative patients is accepted Conference abstracts will be included to reflect recent research data. An article written in non-English language will be excluded.
Inclusion Criteria, Patients
Patients with NSCLC indicated for NAC will be included, covering both early-stage and locally advanced diseases. We will not regulate the pathological subtype of NSCLC (i.e., squamous, non-squamous, adenocarcinoma). However, RCTs primarily targeting large cell neuroendocrine carcinoma will be excluded as such cancer is typically treated following a small-cell lung cancer protocol. No restrictions will be set on performance status (PS) or age.
Inclusion Criteria, Treatment
Eligible treatments will include standalone NAC and combined NAC and AC, incorporating at least one ICI medication. The regimen may include cytotoxic agents and molecular targeted therapies as long as it includes ICI. Any platinum doublet chemotherapy combining one of the platinum agents (cisplatin [CDDP], carboplatin [CBDCA], oxaliplatin, nedaplatin, or lobaplatin) with other cytotoxic agents will collectively be regarded platinum doublet therapy, reflecting the common practice of allowing physician preference among platinum doublets. RCTs examining standalone AC and RCTs focused on radiotherapy will be excluded from our review.
Key exclusion criteria
None
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Chemotherapy Center
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa, Yokohama, Japan
TEL
045-787-2800
horitano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Chemotherapy Center
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa, Yokohama, Japan
TEL
045-787-2800
Homepage URL
horitano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Other
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 Hospital
Address
3-9, Fukuura, Kanazawa, Yokohama, Japan
Tel
045-787-2800
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
| 2024 | Year | 06 | Month | 14 | 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
| 2024 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Statistical Analyses
We will employ the frequentist weighted least squares approach random-model network meta-analysis. The OR of a binary outcome will be continuously corrected by adding 0.5 if at least one cell of the two-by-two contingency table is null. The OR and HR will be log-converted prior to meta-analysis. R software (Command: netmeta, Package: netmeta) will be used for the analysis. The significance threshold will be set at p < 0.05.
Management information
Registered date
| 2024 | Year | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062459
