UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062375 |
|---|---|
| Receipt number | R000071329 |
| Scientific Title | A multicenter prospective observational study evaluating the efficacy and safety of amivantamab plus lazertinib in patients with EGFR (exon19 deletion or L858R)-mutated advanced or recurrent NSCLC previously treated with osimertinib (with or without chemotherapy) |
| Date of disclosure of the study information | 2026/07/28 |
| Last modified on | 2026/07/28 18:17:01 |
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Basic information
Public title
A prospective observational study of amivantamab plus lazertinib in patients with EGFR-mutated non-small cell lung cancer previously treated with osimertinib (NJLCG2501)
Acronym
NJLCG2501
Scientific Title
A multicenter prospective observational study evaluating the efficacy and safety of amivantamab plus lazertinib in patients with EGFR (exon19 deletion or L858R)-mutated advanced or recurrent NSCLC previously treated with osimertinib (with or without chemotherapy)
Scientific Title:Acronym
NJLCG2501
Region
| Japan |
Condition
Condition
EGFR-mutated advanced or recurrent non-small cell lung cancer
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the efficacy and safety of amivantamab plus lazertinib in patients with EGFR-mutated advanced or recurrent non-small cell lung cancer previously treated with osimertinib.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free survival (PFS), defined as the time from the start of treatment to disease progression per RECIST v1.1 or death from any cause. The median and two-sided 95% confidence interval are estimated by the Kaplan-Meier method.
Key secondary outcomes
Objective response rate (ORR), disease control rate (DCR), time to treatment failure (TTF), overall survival (OS), and incidence of adverse events (safety per CTCAE v5.0).
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
- Histologically diagnosed non-small cell lung cancer that is advanced, or recurrent after surgery or radiotherapy.
- Confirmed EGFR mutation (exon 19 deletion or L858R).
- Prior treatment with osimertinib (with or without chemotherapy).
- ECOG performance status of 0-2.
- Age 20 years or older at the time of informed consent.
- Able to take oral medication.
- Measurable lesion(s) according to RECIST version 1.1.
- Adequate laboratory values within 14 days before enrollment: neutrophil count >=1,500/mm3; hemoglobin >=9.0 g/dL; platelet count >=100,000/mm3; total bilirubin <=1.5 mg/dL (<=2.0 mg/dL in patients with liver metastases); AST and ALT <=2.5 times the upper limit of the institutional normal range (<=5 times in patients with liver metastases); SpO2 >=94% or PaO2 >=70 Torr on room air.
- Expected survival of 3 months or longer from enrollment.
- Written informed consent obtained from the patient after sufficient explanation of the study.
Key exclusion criteria
- Symptomatic brain metastases or symptomatic meningeal carcinomatosis.
- Radiotherapy with a field including the chest (including palliative irradiation) within the preceding 2 weeks, or scheduled in the near future. Palliative radiotherapy whose field does not include the lung (e.g., for bone metastases) is allowed.
- Active interstitial lung disease.
- Clinically significant coagulation disorder.
- Contraindication to amivantamab or lazertinib.
- Participation in another clinical study for which co-enrollment in this study is not permitted.
- History of severe drug hypersensitivity.
- Any other condition that the physician judges to make the patient inappropriate for participation in this study.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Miyauchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
022-717-8539
eisaku.miyauchi.b5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Ito |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
022-717-8539
Homepage URL
tatsunori.ito.b1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Medicine, Tohoku University
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel
022-717-7146
ec@rinri.hosp.tohoku.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
東北大学病院（宮城県）
坂総合病院（宮城県）
大曲厚生医療センター（秋田県）
仙台厚生病院（宮城県）
弘前大学医学部附属病院（青森県）
山形県立中央病院（山形県）
宮城県立がんセンター（宮城県）
山梨県立中央病院（山梨県）
大館市立総合病院（秋田県）
山形大学医学部（山形県）
富山大学附属病院（富山県）
岩手県立中央病院（岩手県）
佐久医療センター（長野県）
岩手県立胆沢病院（岩手県）
八戸市立市民病院（青森県）
秋田厚生医療センター（秋田県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 28 | 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 | 07 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
A multicenter, prospective, observational study. Eligible patients who receive amivantamab plus lazertinib as part of routine clinical practice are consecutively enrolled, and information obtained in routine care (patient characteristics, EGFR mutation status, prior treatments, treatment administration, tumor response per RECIST version 1.1, adverse events per CTCAE version 5.0, and survival) is collected from medical records. No additional examinations or interventions are performed for this study; the timing of examinations and assessments follows routine clinical practice at the discretion of the attending physician. The observation period continues until March 2029.
Management information
Registered date
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071329
