UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062590 |
|---|---|
| Receipt number | R000071643 |
| Scientific Title | A multicenter prospective observational study of the effectiveness and safety of first-line amivantamab plus lazertinib combination therapy in EGFR-mutated non-small cell lung cancer |
| Date of disclosure of the study information | 2026/08/17 |
| Last modified on | 2026/08/17 00:38:06 |
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Basic information
Public title
A study of the effectiveness and side effects of first-line amivantamab plus lazertinib combination therapy for advanced or recurrent EGFR-mutated non-small cell lung cancer
Acronym
AMIGO study
Scientific Title
A multicenter prospective observational study of the effectiveness and safety of first-line amivantamab plus lazertinib combination therapy in EGFR-mutated non-small cell lung cancer
Scientific Title:Acronym
AMIGO study
Region
| Japan |
Condition
Condition
Advanced or recurrent EGFR-mutated non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This multicenter prospective observational study aims to evaluate the real-world effectiveness and safety of first-line amivantamab plus lazertinib combination therapy in patients with advanced or recurrent EGFR-mutated non-small cell lung cancer. The study also aims to explore predictors of treatment efficacy and adverse events by investigating associations of patient background factors, gut microbiota, peripheral blood immune cell profiles, the tumor microenvironment, and cancer- and immune-related protein expression in tumor tissue with treatment efficacy and safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-Free Survival: PFS
Key secondary outcomes
Overall survival (OS): Time from study registration to death from any cause. Follow-up is planned through April 30, 2031.
Objective response rate (ORR): Proportion of patients whose best overall response is complete response (CR) or partial response (PR).
Safety: Incidence and types of adverse events observed during amivantamab plus lazertinib combination therapy.
Associations of patient background factors with treatment efficacy and safety.
Associations of gut microbiota, peripheral blood immune cell profiles, and the tumor microenvironment with treatment efficacy and safety.
Associations of cancer-related protein expression in tumor tissue with treatment efficacy and safety.
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
| 18 | years-old | <= |
Age-upper limit
| 200 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older at the time of informed consent with an ECOG Performance Status of 0-2.
Patients with non-small cell lung cancer harboring an EGFR exon 19 deletion or L858R mutation.
Patients with unresectable stage III disease, stage IV disease, or postoperative recurrence.
Patients with evaluable disease according to RECIST version 1.1.
Patients who have not previously received an EGFR-TKI and are scheduled to receive amivantamab plus lazertinib as first-line treatment. Only subcutaneous administration of amivantamab is permitted.
Patients who have received sufficient explanation of the study and provided written informed consent of their own free will.
Key exclusion criteria
Patients who are considered inappropriate for participation in this study by the treating physician for any other reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Yamada |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine, Graduate School of Medical Science
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515513
tayamada@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Kawachi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine, Graduate School of Medical Science
Zip code
6028566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515513
Homepage URL
kwhat@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Respiratory Medicine and Infectious Diseases, Niigata University Medical and Dental Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Institutional Review Board
Address
465 Kajii-cho, Kamigyo-ku, Kyoto City, Kyoto Prefecture, Japan
Tel
0752515111
rinri@koto.kpu-m.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
1 京都府立医科大学附属病院 京都府
2 宇治徳洲会病院 京都府
3 金沢大学附属病院 石川県
4 京都第一赤十字病院 京都府
5 京都第二赤十字病院 京都府
6 島根大学医学部附属病院 島根県
7 聖マリアンナ医科大学病院 神奈川県
8 市立福知山市民病院 京都府
9 新潟県立がんセンター新潟病院 新潟県
10 新潟大学医歯学総合病院 新潟県
11 日本医科大学付属病院 東京都
12 函館五稜郭病院 北海道
13 弘前大学医学部附属病院 青森県
14 福井大学医学部附属病院 福井県
15 藤田医科大学病院 愛知県
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2031 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective observational study. Patients with advanced or recurrent non-small cell lung cancer harboring an EGFR exon 19 deletion or L858R mutation who are scheduled to receive first-line amivantamab plus lazertinib combination therapy as part of routine clinical practice will be prospectively enrolled if they meet the eligibility criteria and provide written informed consent.
Clinical information will be prospectively collected to evaluate progression-free survival, overall survival, objective response rate, and safety. Stool samples will be collected at baseline, after three treatment cycles, and at 6-9 months for gut microbiota analysis. Residual blood samples obtained as part of routine clinical care at baseline and after three treatment cycles, as well as residual diagnostic tumor tissue, will also be analyzed to assess peripheral blood immune cell profiles, the tumor microenvironment, and cancer- and immune-related protein expression. Associations of these biomarkers with treatment efficacy and safety will be explored. The planned sample size is 50 patients.
Management information
Registered date
| 2026 | Year | 08 | Month | 17 | Day |
Last modified on
| 2026 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071643
