UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060812 |
|---|---|
| Receipt number | R000069570 |
| Scientific Title | LONG-TERM FOLLOW-UP OF OSIMERTINIB IN COMBINATION WITH PLATINUM AND PEMETREXED IN PATIENTS WITH PREVIOUSLY UNTREATED EGFR-MUTATED ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (THE OPAL STUDY): (NEJ032D) |
| Date of disclosure of the study information | 2026/03/04 |
| Last modified on | 2026/03/03 22:15:22 |
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Basic information
Public title
LONG-TERM FOLLOW-UP OF OSIMERTINIB IN COMBINATION WITH PLATINUM AND PEMETREXED IN PATIENTS WITH PREVIOUSLY UNTREATED EGFR-MUTATED ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (THE OPAL STUDY): (NEJ032D)
Acronym
NEJ032D
Scientific Title
LONG-TERM FOLLOW-UP OF OSIMERTINIB IN COMBINATION WITH PLATINUM AND PEMETREXED IN PATIENTS WITH PREVIOUSLY UNTREATED EGFR-MUTATED ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (THE OPAL STUDY): (NEJ032D)
Scientific Title:Acronym
NEJ032D
Region
| Japan |
Condition
Condition
previously untreated EGFR-mutated advanced non-squamous NSCLC
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to conduct a long-term follow-up data analysis of the phase II OPAL trial, which evaluated osimertinib plus platinum-based chemotherapy (cisplatin or carboplatin) and pemetrexed in patients with previously untreated EGFR-mutated advanced non-squamous NSCLC, to clarify the long-term efficacy of this regimen and its effectiveness in previously unreported subgroup populations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. All 67 patients (34 in the cisplatin group and 33 in the carboplatin group) enrolled in the phase II trial of osimertinib in combination with platinum-pemetrexed in patients with EGFR-mutated previously untreated advanced non-small cell Lung cancer (the OPAL study) conducted between March 1, 2019 and May 31, 2024.
Trial: Phase II trial of osimertinib in combination with platinum-pemetrexed in patients with EGFR-mutated previously untreated advanced non-small cell Lung cancer (the OPAL study)
2. Individuals who did not express refusal to participate in this study, either themselves or through a representative who could act on their behalf and in their best interests.
Key exclusion criteria
Patients who withdrew their consent.
Target sample size
67
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Asahina |
Organization
National Hospital Organization Hokkaido Cancer Center
Division name
Department of Respiratory Medicine
Zip code
003-0804
Address
4-2-3-54 Kikusui, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL
011-811-9111
hajime.asahina@gmail.com
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Furuta |
Organization
Hokkaido University Hospital
Division name
Respiratory Medicine
Zip code
060-8648
Address
North 15, West 7, Kita-ku, Sapporo, Japan
TEL
011-706-5911
Homepage URL
furutamegumi@pop.med.hokudai.ac.jp
Sponsor or person
Institute
North East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who enrolled in the phase II trial of osimertinib in combination with platinum-pemetrexed in patients with EGFR-mutated previously untreated advanced non-small cell Lung cancer (the OPAL study), which was conducted from March 1, 2019 to May 31, 2024.
Management information
Registered date
| 2026 | Year | 03 | Month | 03 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069570
