Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06106802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-30
First Post:
2023-10-12
Brief Title:
Lazertinib Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Lazertinib and Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment A Phase II Multi-center Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As the 3rd generation EGFR TKI has become a standard treatment option for the 1st line therapy in EGFR mutated patients the necessity for evaluating resistant mechanism to determine the matched subsequent therapeutic option has been highlighted From the 1st line Osimertinib treatment the heterogenous resistance mechanism has been observed showing most commonly by MET amplification 7-15 followed by additional on-target EGFR mutation 6-10 BRAF PI3KCA KRAS HER2 mutation 13-14 and still 40 to 50 remain unknown for the mechanism A Leonetti et alBritish Journal of Cancer2019
Based on the observation showing the MET amplification as the most common resistance mechanism to the 3rd generation EGFR TKI treatment the TATTON study a multi-arm phase IB trial demonstrated early clinical data of Osimertinib in combined with savolitinib Among the patients c-MET amplified patients who were previously treated with 3rd generation EGFR TKI a combination of Osimertinib and savolitinib showed an objective response rate of 33 and median PFS of 55 months G Oxnard et al Annals of Oncology2020
The clinical efficacy of Osimertinib with savolitinib in MET overexpressed or amplification patients are reported from the global phase II SAVANNAH study The preliminary results from the SAVANNAH trial showed that Osimertinib plus savolitinib demonstrated an objective response rate of 49 in patients with a high level of MET overexpression andor amplification defined as IHC90 andor FISH 10 whose disease progressed on treatment with Osimertinib The highest ORR was observed in patients with a high level of MET who were not treated with prior chemotherapy 52 In patients whose tumors did not show a high level of MET the ORR was 9 MJ Ahn WCLC 2022 There are ongoing global Phase III SAFFRON study to validate the outcome from SAVANNAH study
It has been reported that around 62 of tumor in Osimertinib progressed sample has MET overexpression andor amplification and more than one-third 34 met the defined high MET level cut-off
As Lazertinib is about to be approved as the treatment option for the treatment naïve EGFR mutated NSCLC it is also becoming important to develop a further treatment plan based on the MET amplification status In this study the investigators designed a phase II study based on the MET amplification status to evaluate the clinical efficacy of Lazertinib tepotinib
Based on the observation showing the MET amplification as the most common resistance mechanism to the 3rd generation EGFR TKI treatment the TATTON study a multi-arm phase IB trial demonstrated early clinical data of Osimertinib in combined with savolitinib Among the patients c-MET amplified patients who were previously treated with 3rd generation EGFR TKI a combination of Osimertinib and savolitinib showed an objective response rate of 33 and median PFS of 55 months G Oxnard et al Annals of Oncology2020
The clinical efficacy of Osimertinib with savolitinib in MET overexpressed or amplification patients are reported from the global phase II SAVANNAH study The preliminary results from the SAVANNAH trial showed that Osimertinib plus savolitinib demonstrated an objective response rate of 49 in patients with a high level of MET overexpression andor amplification defined as IHC90 andor FISH 10 whose disease progressed on treatment with Osimertinib The highest ORR was observed in patients with a high level of MET who were not treated with prior chemotherapy 52 In patients whose tumors did not show a high level of MET the ORR was 9 MJ Ahn WCLC 2022 There are ongoing global Phase III SAFFRON study to validate the outcome from SAVANNAH study
It has been reported that around 62 of tumor in Osimertinib progressed sample has MET overexpression andor amplification and more than one-third 34 met the defined high MET level cut-off
As Lazertinib is about to be approved as the treatment option for the treatment naïve EGFR mutated NSCLC it is also becoming important to develop a further treatment plan based on the MET amplification status In this study the investigators designed a phase II study based on the MET amplification status to evaluate the clinical efficacy of Lazertinib tepotinib
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None