UMIN-ICDS Clinical Trial

Public title

Adjuvant therapy in pathological stage IA2-IIA EGFR-mutated NSCLC: a multicenter prospective observational study (WJOG17123L)

Acronym

Adjuvant therapy in pathological stage IA2-IIA EGFR-mutated NSCLC: a multicenter prospective observational study (WJOG17123L)

Scientific Title

Adjuvant therapy in pathological stage IA2-IIA EGFR-mutated NSCLC: a multicenter prospective observational study (WJOG17123L)

Scientific Title:Acronym

Adjuvant therapy in pathological stage IA2-IIA EGFR-mutated NSCLC: a multicenter prospective observational study (WJOG17123L)

Region

Japan

Condition

Completely resected pathological stage IA2-IIA EGFR-mutated NSCLC

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To clarify the outcomes of postoperative adjuvant therapy in patients with EGFR mutation-positive non-squamous non-small cell lung cancer with a total tumor size of 5 cm or less and pathologic stages IA2 to IIA who have had complete resection by curative surgery without prior treatment through a prospective observational study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Disease-free survival

Key secondary outcomes

Overall survival, proportion of treatment completion, type of recurrence, type of treatment after recurrence, adverse events

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically proven non-squamous non-small cell lung cancer
2) Pathological stage IA2 and high risk, or stage IA3, IB, IIA (TNM 8th edition)
Pathological high-risk cases are satisfying any of the following factors.
- Lymphovascular invasion
- High-grade histological type (micropapillary, solid, or complex gland adenocarcinoma >= 20%)
3) Total tumor diameter <= 5 cm
4) No preoperative treatment
5) Complete resection by lobectomy or segmentectomy.
6) MRI or CT scan of the brain must be done prior to surgery. Patients in whom this was not done prior to surgery may still be enrolled if MRI or CT scan is performed prior to registration .
7) EGFR gene mutations have been identified (two frequent EGFR mutations [Ex19del or L858R] expressed alone or simultaneously with other EGFR mutations [T790M, G719X, exon 20 insertion, S7681, L861Q, etc.])
8) Postoperative adjuvant therapy with tegafur-uracil or Osimertinib, or observation without treatment is planned.
9) Age at consent: 18 years and older
10) ECOG performance status (PS) 0-1
11) Latest laboratory values within 56 days prior to enrollment meet all of the following. (postoperative, same day of the week 8 weeks prior to enrollment is acceptable)
- Neutrophil count (absolute) >= 1,500 /mm3
- Platelet count >= 100,000 /mm3
- Hemoglobin >= 9.0 g/dL
- ALT <= 105 U/L (male), <= 57.5 U/L (female)
- AST <= 75 U/L
- Total bilirubin <= 2.25 mg/dL
or confirmed Gilbert's syndrome (unconjugated hyperbilirubinemia), total bilirubin <= 4.5 mg/dL
- Creatinine <= 1.605 mg/dL (male), <= 1.185 mg/dL (female)
or creatinine clearance >= 50 mL/min (measured value or value calculated by the Cockcroft-Gault formula should be used).
Creatinine clearance will be evaluated only when creatinine exceeds 1.605 mg/dL (male) or 1.185 mg/dL (female).
12) Written consent is obtained.

Key exclusion criteria

1) Patients with active double cancers *1
2) Patients with a localized or systemically active infection requiring treatment
3) Pregnant women, lactating women, and women who may be currently pregnant
4) Patients with clinically problematic psychiatric disorders that would preclude enrollment in the study
5) Patients receiving continuous systemic administration of steroids or immunosuppressive agents
6) Patients with history of serious hypersensitivity
7) Exclusions for complications
(i) History of ILD, drug-induced ILD, radiation pneumonitis requiring steroid therapy, or active ILD.
(ii) Viral hepatitis
HBs antigen positive or HCV antibody positive
(iii) HIV-positive (but negative confirmation by serologic testing is not required).
8) Other cases deemed inappropriate by the physician in charge
*1 Double cancers are defined as synchronous duplications and heterochronic duplications with a disease-free interval of 5 years or less. Carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma equivalent lesions that are considered curable by local treatment are not included in active double cancers.

Target sample size

800

Name of lead principal investigator

1st name	Keiju
Middle name
Last name	Aokage

Organization

National Cancer Center Hospital East

Division name

Department of Thoracic Surgery

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa-shi, Chiba 277-8577, Japan

TEL

04-7133-1111

Email

kaokage@east.ncc.go.jp

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/

Email

datacenter@wjog.jp

Institute

West Japan Oncology Group

Institute

Department

Personal name

Organization

AstraZeneca K.K

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

02

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

08

Month

24

Day

Date of IRB

Anticipated trial start date

2024

Year

04

Month

01

Day

Last follow-up date

2032

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Prospective observational study
We will include patients who visited 49 participating centers, met the selection criteria, and provided consent to participate in the study.
The endpoints include disease-free survival, overall survival, proportion of treatment completion, type of recurrence, type of treatment after recurrence, and adverse events.

Registered date

2024

Year

02

Month

01

Day

Last modified on

2024

Year

02

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061076