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Trial Title:
Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
NCT ID:
NCT06525246
Condition:
Stage IIIB Non-small Cell Lung Cancer
Stage IIIC Non-Small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Recurrent Non-Small Cell Lung Cancer
EGFR Mutation-Related Tumors
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Osimertinib
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ONO-7475
Description:
Specified dose, once daily
Arm group label:
ONO-7475+Osimertinib
Intervention type:
Drug
Intervention name:
Osimertinib Mesylate
Description:
Specified dose, once daily
Arm group label:
ONO-7475+Osimertinib
Summary:
This study is to evaluate the tolerability and safety of ONO-7475 in combination with
osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV
or recurrent non-small cell lung cancer (NSCLC), which is unsuitable for radical
irradiation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with stage IIIB/IIIC/IV or recurrent NSCLC, which is unsuitable for radical
irradiation
2. Patients with confirmed EGFR gene exon 19 deletion or EGFR gene exon 21
mutation(L858R)and who are scheduled to receive osimertinib
3. Patient has an ECOG performance status of 0-1
Exclusion Criteria:
1. Patients with severe complication
2. Patients with multiple primary cancers
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Hospital Organization Shikoku Cancer Center
Address:
City:
Matsuyama-shi
Country:
Japan
Facility:
Name:
Kobe City Medical Center General Hospital
Address:
City:
Kobe-shi
Country:
Japan
Facility:
Name:
Hyogo College Of Medicine College Hospital
Address:
City:
Nishinomiya
Country:
Japan
Facility:
Name:
Kitasato University Hospital
Address:
City:
Sagamihara-shi
Country:
Japan
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Yokohama shi
Country:
Japan
Facility:
Name:
Saitama Cancer Center
Address:
City:
Ina
Country:
Japan
Facility:
Name:
University Hospital Kyoto Prefectural University of Medicine
Address:
City:
Kyoto-shi
Country:
Japan
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka-shi
Country:
Japan
Facility:
Name:
Osaka Medical and Pharmaceutical University Hospital
Address:
City:
Takatsuki
Country:
Japan
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Nagaizumi-chō
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital Of JFCR
Address:
City:
Koto-Ku
Country:
Japan
Facility:
Name:
Tokyo Medical University Hospital
Address:
City:
Shinjuku-Ku
Country:
Japan
Facility:
Name:
Nigata Cancer Center Hospital
Address:
City:
Niigata
Country:
Japan
Start date:
August 6, 2021
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Ono Pharmaceutical Co. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06525246
