UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063371 |
|---|---|
| Receipt number | R000072532 |
| Scientific Title | Phase III Non-Inferiority Trial of Postoperative Immunotherapy vs. Observation after NEoadjuvant chemoimmunotherapy and completE Resection for clinical stage II-IIIB non-small cell lung cancer (PIONEER) (WJOG24225L) |
| Date of disclosure of the study information | 2026/10/26 |
| Last modified on | 2026/10/22 09:25:08 |
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Basic information
Public title
Phase III Non-Inferiority Trial of Postoperative Immunotherapy vs. Observation after NEoadjuvant chemoimmunotherapy and completE Resection for clinical stage II-IIIB non-small cell lung cancer (PIONEER) (WJOG24225L)
Acronym
PIONEER
Scientific Title
Phase III Non-Inferiority Trial of Postoperative Immunotherapy vs. Observation after NEoadjuvant chemoimmunotherapy and completE Resection for clinical stage II-IIIB non-small cell lung cancer (PIONEER) (WJOG24225L)
Scientific Title:Acronym
PIONEER
Region
| Japan |
Condition
Condition
Clinical stage II-IIIB non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether omission of adjuvant immunotherapy is non-inferior to adjuvant immunotherapy in terms of recurrence-free survival (RFS) in patients with EGFR/ALK-negative or unknown non-small cell lung cancer (NSCLC) who have undergone complete resection following neoadjuvant chemoimmunotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence-free survival
Key secondary outcomes
Overall survival (OS), medical costs, adverse events, quality of life (QOL) assessed using the EQ-5D-5L, comparison of prognosis between patients with pathological complete response (pCR) and those without pCR, comparison of prognosis between patients with major pathological response (MPR) and those without MPR, comparison of prognosis according to the percentage of residual viable tumor (%RVT), comparison of prognosis between patients with PD-L1 expression >=1% and <1%, and comparison of prognosis between patients treated with anti-PD-1 antibodies and those treated with anti-PD-L1 antibodies.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adjuvant immunotherapy
Interventions/Control_2
Observation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with clinical stage II-IIIB (excluding N3 disease in stage IIIB) non-small cell lung cancer (NSCLC), according to the 9th edition of the UICC TNM classification, with negative or unknown EGFR mutation and ALK rearrangement status. For patients with adenocarcinoma, negative EGFR and ALK status is required unless testing cannot be performed for unavoidable reasons, such as insufficient tissue samples. Patients with non-adenocarcinoma NSCLC with unknown EGFR and/or ALK status are eligible.
2) Patients who have undergone complete resection (R0 resection) following neoadjuvant chemoimmunotherapy. Neoadjuvant treatment must have consisted of an immune checkpoint inhibitor (ICI; pembrolizumab or durvalumab) combined with histology-appropriate platinum-based chemotherapy, with at least the following number of ICI administrations:
-Pembrolizumab 200 mg every 3 weeks: at least 3 administrations.
-Durvalumab 1500 mg every 3 weeks: at least 3 administrations.
3) Patients aged 18 years or older at the time of informed consent for study registration.
4) Patients who have provided written informed consent after receiving a sufficient explanation of the study procedures and requirements.
5) Patients who are considered eligible to receive adjuvant immunotherapy with the same ICI used during neoadjuvant treatment and who meet all of the following criteria at registration:
6) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7) Patients who meet all of the following laboratory criteria, based on the most recent results obtained within 28 days before registration (tests performed on the same day of the week 4 weeks before registration are acceptable):
1. White blood cell count >=3,000/mm^3
8) No history of chemotherapy*1,*2 or radiotherapy for malignancy within the 2 years before registration, except for neoadjuvant chemoimmunotherapy administered for the NSCLC targeted in this study.
Key exclusion criteria
1) Patients with active multiple primary malignancies.
2) Patients with active systemic infections, active infections including hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection (e.g., patients receiving treatment for an active infection), or uncontrolled active hepatitis B virus (HBV) infection.
3) Patients with autoimmune diseases requiring systemic treatment. Endocrine immune-related adverse events (irAEs), such as hypothyroidism, hyperthyroidism, or adrenal insufficiency, are not exclusion criteria if they are clinically stable with hormone replacement therapy or appropriate endocrine treatment and do not require immunosuppressive therapy.
4) Patients who developed irAEs during or after neoadjuvant immune checkpoint inhibitor therapy for which permanent discontinuation of immune checkpoint inhibitors is recommended according to the ASCO and NCCN guidelines for irAE management. These include myocarditis, encephalitis, transverse myelitis, Grade 3-4 myasthenia gravis, Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), Grade 4 irAEs other than endocrine disorders, and other relevant conditions.
5) Patients with a history of Grade >=2 ICI-related pneumonitis or active interstitial lung disease/pneumonitis at the time of registration.
6) Patients who are pregnant, breastfeeding, suspected to be pregnant, or unwilling to use contraception.
7) Patients who are considered unsuitable for study enrollment due to clinically significant postoperative complications or psychiatric disorders.
8) Patients receiving continuous systemic administration (oral or intravenous) of corticosteroids at a dose exceeding 10 mg/day of prednisolone equivalent or other immunosuppressive agents.
9) Patients with a history of severe hypersensitivity reactions.
10) Patients with postoperative complications of Clavien-Dindo Grade IIIa or higher.
Target sample size
366
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tsutani |
Organization
Kindai University Faculty of Medicine
Division name
Division of Thoracic Surgery, Department of Surgery
Zip code
590-0197
Address
1-14-1 Miharadai, Minami-ku, Sakai, Osaka, Japan
TEL
072-288-7222
tsutani@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
https://www.wjog.jp/studys/
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
none
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
Kindai University Faculty of Medicine
Address
1-14-1 Miharadai, Minami-ku, Sakai, Osaka, Japan
Tel
072-288-7222
1-14-1 Miharadai, Minami-ku, Sakai, Osaka, Japan
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
| 2026 | Year | 10 | Month | 26 | 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
| 2026 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2036 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 22 | Day |
Last modified on
| 2026 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072532
