non-small cell lung cancer non-small cell lung cancer, NSCL, Exon20ins
Conditions
Interventions
None listed
Sponsors
Yamada Tadaaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed with advanced or recurrent non-small cell lung cancer (NSCLC) prior to enrollment. The TNM classification of lung tumors is based on the 9th edition of the UICC TNM Classification (2024). 2)Patients confirmed to have EGFR Exon 20 insertion mutations. 3)Patients who are scheduled to receive treatment with amivantamab in combination with chemotherapy (carboplatin and pemetrexed sodium). 4)Patients who are 20 years of age or older at the time of obtaining informed consent. 5)Patients who have received a thorough explanation of the study and have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients who are receiving chemotherapy, investigational products, biological therapy, or hormonal therapy for cancer at the time of enrollment. However, patients are eligible if such treatments will be completed prior to the initiation of the protocol-specified treatment. 2)Patients who are receiving thoracic radiotherapy for cancer at the time of enrollment. Palliative radiotherapy for conditions such as bone metastases is permitted. 3)Patients participating in other clinical studies for which co-enrollment with this study is not allowed. Note: This study does not impose restrictions on co-enrollment with other studies. 4)Patients whom the principal investigator or sub-investigator deems inappropriate for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1year-Progression Free Survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| -Secondary endpoints Progression Free Survival (PFS), Objective Response Rate (ORR), Time to Treatment Failure (TTF), Safet (Adverse Events (AEs)), Prevention and management of dermatologic adverse events -Exploratory endpoints Investigation of biomarkers related to the efficacy and safety of the treatment (genomic analysis): 1)Prior to the initiation of protocol-specified treatment 2)At the earlier of the following time points: Within 30 days after treatment discontinuation or completion, or Before the initiation of subsequent therapy | — |
Contacts
Public ContactRyo Sawada
University Hospital, Kyoto Prefectural University of Medicine
Outcome results
None listed