UMIN-ICDS Clinical Trial

Public title

Real-world data on the effectiveness and safety of MARIPOSA/MARIPOSA-2 regimens after first-line osimertinib-based therapy in EGFR-mutated NSCLC: A multicenter prospective observational study (NEJ073)

Acronym

MARIPOSA/MARIPOSA-2 observational study (NEJ073)

Scientific Title

A multicenter prospective observational study of the effectiveness and safety of amivantamab-based regimens (MARIPOSA/MARIPOSA-2) after first-line osimertinib-based therapy in patients with EGFR mutation-positive non-small cell lung cancer (NEJ073)

Scientific Title:Acronym

MARIPOSA/MARIPOSA-2 multicenter prospective observational study (NEJ073)

Region

Japan

Condition

Advanced non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness and safety of the amivantamab-based regimens (MARIPOSA/MARIPOSA-2) following first-line osimertinib-based therapy (FLAURA or FLAURA2 regimens) in patients with EGFR mutation-positive non-small cell lung cancer, and to assess clinical factors associated with treatment outcomes and indirectly compare the effectiveness with established standard treatments.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Progression-free survival (PFS), Overall survival (OS)

Key secondary outcomes

1) PFS and OS by subgroup factors
2) Safety
3) Objective response rate (ORR)
4) Disease control rate (DCR)
5) Time to treatment failure (TTF)
6) Rate of transition to subsequent therapy

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Pathologically confirmation of non small cell lung cancer
2) The history of EGFR-TKI therapies
3) Not eligible for surgery or definitive radiotherapy
4) Disease progression has been confirmed following first-line osimertinib-based therapy
5) Administration of amivantamab-based therapy (MARIPOSA/MARIPOSA-2) is planned
6) Presence of evaluable lesions (with or without measurable lesions according to RECIST Version 1.1)
7) Aged 20 or more
8) Written informed consent

Key exclusion criteria

1) Patients who received osimertinib as adjuvant chemotherapy or as consolidation therapy following curative radiation therapy (ADAURA, LAURA).
2) Patients with active interstitial lung disease.

Target sample size

100

Name of lead principal investigator

1st name	Masahide
Middle name
Last name	Mori

Organization

NHO Osaka Toneyama Medical Center

Division name

Department of Thoracic Oncology

Zip code

560-8552

Address

5-1-1 Toneyama, Toyonaka, Osaka 560-8552, Japan

TEL

(+81)06-6853-2001

Email

mori.masahide.fr@mail.hosp.go.jp

Name of contact person

1st name	Takahisa
Middle name
Last name	Kawamura

Organization

NHO Osaka Toneyama Medical Center

Division name

Department of Thoracic Oncology

Zip code

560-8552

Address

5-1-1 Toneyama, Toyonaka, Osaka 560-8552, Japan

TEL

(+81)06-6853-2001

Homepage URL

Email

takahisa1104@gmail.com

Institute

NHO Osaka Toneyama Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Center for Ethical Review, NHO Osaka Toneyama Medical Center

Address

5-1-1 Toneyama, Toyonaka City

Tel

(+81)06-6853-2001

Email

-

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

千葉大学医学部附属病院（千葉県）、県立広島病院（広島県）、函館五稜郭病院（北海道）、信州大学医学部附属病院（長野県）、自治医科大学附属病院（栃木県）、群馬県立がんセンター（群馬県）、日本医科大学付属病院（東京都）、弘前大学医学部附属病院（青森県）、北海道大学病院（北海道）、獨協医科大学日光医療センター（栃木県）、千葉県がんセンター（千葉県）、帯広厚生病院（北海道）、手稲渓仁会病院（北海道）、獨協医科大学病院（栃木県）、山梨県立中央病院（山梨県）、順天堂大学医学部附属浦安病院（千葉県）、新潟大学医歯学総合病院（新潟県）、国立国際医療センター（東京都）、聖マリアンナ医科大学病院（神奈川県）、山梨大学医学部附属病院（山梨県）、埼玉県立がんセンター（埼玉県）、東北医科薬科大学病院（宮城県）、順天堂東京江東高齢者医療センター（東京都）、大曲厚生医療センター（秋田県）、仙台厚生病院（宮城県）、大阪国際がんセンター（大阪府）、順天堂大学医学部附属順天堂医院（東京都）、旭川医科大学病院（北海道）、高知大学医学部附属病院（高知県）、島根大学医学部附属病院（島根県）、さいたま赤十字病院（埼玉県）、東京科学大学病院（東京都）、佐野厚生総合病院（栃木県）、東邦大学医療センター佐倉病院（千葉県）、日本赤十字社長岡赤十字病院（新潟県）、獨協医科大学埼玉医療センター（埼玉県）　ほか

Date of disclosure of the study information

2026

Year

10

Month

13

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

Open public recruiting

Date of protocol fixation

2026

Year

04

Month

28

Day

Date of IRB

2026

Year

09

Month

24

Day

Anticipated trial start date

2026

Year

10

Month

13

Day

Last follow-up date

2030

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

A multicenter prospective observational study
Eligibility criteria include patients who are to receive MARIPOSA/MARIPOSA-2 therapy in practical setting in each participating institution and those who provide written informed consent.

Registered date

2026

Year

10

Month

13

Day

Last modified on

2026

Year

10

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072313