UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000050552
Receipt number	R000057569
Scientific Title	Osimertinib and Other Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitors for Untreated Advanced EGFR-Mutated Non-small Cell Lung Cancer in Japan: Analyzing Updated Data from the TREAD project 01
Date of disclosure of the study information	2023/03/09
Last modified on	2024/12/08 11:47:06

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Basic information

Public title

Osimertinib and Other Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitors for Untreated Advanced EGFR-Mutated Non-small Cell Lung Cancer in Japan: Analyzing Updated Data from the TREAD project 01

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

advanced EGFR-mutated non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

Therefore, we will retrospectively examine OS using RWD in untreated EGFR-positive (del 19 or L858R) advanced or recurrent non-small cell lung cancer patients who received osimertinib as first-line therapy and those who were T790M positive and treated with osimertinib as second line, or second line or later.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Key secondary outcomes

Base

Study type

Observational

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

20 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients were serially enrolled from the TREAD-01 database. Patients with cytologically or pathologically confirmed non-small cell lung cancer, disease due to sensitizing EGFR mutations (Del19 or L858R), including patients with compound EGFR mutations, who were at least 20 years old at the start of treatment were eligible for enrollment.47 hospitals participating in the TREAD project in the TREAD project received first-line treatment with gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib and at least one dose of osimertinib during the entire treatment period from April 2010 to 2022.

Key exclusion criteria

EExclusion criteria include: de novo EGFR T790 M mutation, active multiple cancers, failure to provide informed consent (opting to opt-out), poor data extraction (e.g., missing details of previous cancer treatment at other hospitals or individual patient data), simultaneous and metachronous double cancers other than in situ/intramucosal cancer cured by local treatment or endoscopic lesions diagnosed as in situ cancer, and disease-free for 5 years or less.

Target sample size

500

Research contact person

Name of lead principal investigator

1st name Makoto

Middle name

Last name Hibino

Organization

Shonan Fujisawa Tokushukai Hospital

Division name

Respiratory medicine

Zip code

2510041

Address

1-5-1, Kandaitsujido, Fujisawa

TEL

0466351177

Email

m-hibino@ctmc.jp

Public contact

Name of contact person

1st name Makoto

Middle name

Last name Hibino

Organization

Shonan Fujisawa Tokushukai Hospital

Division name

Resoiratory medicne

Zip code

2510041

Address

1-5-1, Tsujidoknadai, Fujisawa

TEL

0466351177

Homepage URL

Email

m-hibino@ctmc.jp

Sponsor or person

Institute

Shonan Fujisawa Tokushukai Hospital

Institute

Department

Personal name

Funding Source

Organization

self-financing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Tokushukai Group Institutional Review Board

Address

Kudamminami, Chiyoda-ku, Tokyo, Japan

Tel

03-3263-4801

Email

homepage@tokushukai.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2023 Year 03 Month 09 Day

Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s11523-024-01094-5

Publication of results

Published

Result

URL related to results and publications

https://link.springer.com/article/10.1007/s11523-024-01094-5

Number of participants that the trial has enrolled

1062

Results

Among 1062 Japanese patients with EGFR-mutated non-small cell lung cancer, 416 (39.2%) received 1L-Osi, while 646 (60.8%) received 1L-non-Osi, including 139 (13.1%) who received 2L/later-Osi. After propensity score matching, the overall survival of the 1L-Osi group was comparable to that of the 1L-non-Osi group in the post-March 2016 subset (n = 283, 42.0 vs 42.4 months).

Results date posted

2024 Year 12 Month 08 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The baseline demographics and clinical characteristics of the included patients are summarized in Table 1. The predominant histological subtype was adenocarcinoma, with most patients in Stage IV and a high prevalence of patients with a good performance status. A significant proportion of patients were never smokers. Mutations in addition to Del19 and L858R included G719X (n = 44), L861Q (n = 25), S768I (n = 8), exon 20 insertions (n = 5), exon 19 insertions (n = 1), G719X with S768I (n = 6), and G719X with E709A (n = 2).

Participant flow

A flowchart of the study participant selection process is shown in Fig. 1. Of the 1380 patients considered for enrollment, 1062 patients with EGFR-mutated advanced or recurrent NSCLC, treated with any EGFR-TKI as first-line palliative treatment, were eligible. We identified 555 patients who received at least one dose of osimertinib during the treatment period: 416 and 139 patients in the 1L-Osi and 2L/later-Osi groups, respectively, with 103 and 36 receiving it as second-line and later-line treatments, respectively. A total of 646 patients were included in the 1L-non-Osi group: 404 received gefitinib, 119 received erlotinib, and 123 received afatinib as first-line treatment. Among the 293 patients for whom first-line treatment was initiated after March 2016 in the 1L-non-Osi group, 75 (25.6%) received osimertinib as second-line or later-line treatment. In contrast, among patients whose first-line treatment was started before this period, 64 of 353 patients (18.1%) received osimertinib as second-line or later-line treatment. The difference between these proportions was significant (p = 0.03).

Adverse events

Not evaluated in this study.

Outcome measures

The primary endpoint was OS of patients who received osimertinib as first-line therapy (1L-Osi), compared with OS of all patients who received a first-generation or second-generation EGFR-TKI other than osimertinib as first-line therapy (1L-non-Osi), with initiation dates after March 2016. The secondary endpoint was OS of patients who subsequently received osimertinib as second-line or later-line treatment after their first-line treatment with EGFR-TKIs other than osimertinib (2L/later-Osi, initiated after March 2016). Both endpoints were also assessed for the cohort throughout the study period.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2023 Year 03 Month 02 Day

Date of IRB

2023 Year 03 Month 02 Day

Anticipated trial start date

2023 Year 03 Month 02 Day

Last follow-up date

2023 Year 08 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

This is a retrospective study, and the anticipated trial start date and last follow-up date may not align with the actual dates.

Management information

Registered date

2023 Year 03 Month 09 Day

Last modified on

2024 Year 12 Month 08 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057569