Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04512430
Status:
TERMINATED
Last Update Posted:
2023-06-23
First Post:
2020-08-07
Brief Title:
Neo-DIANA Neoadjuvant Treatment for EGFR Mutated Patients
Sponsor:
Fundación GECP
Organization:
Fundación GECP
Study Overview
Official Title:
A Phase II Trial of Neoadjuvant Treatment Carboplatin-Pemetrexed-Bevacizumab Plus Atezolizumab for the Treatment of Locally Advanced and Potentially Resectable NSCLC Patients With EGFR Mutations
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label non-randomised phase II multi-centre clinical trial
26 patients will be enrolled in this trial to evaluate the major pathologic response in patients with neoadjuvant treatment with Carboplatin Pemetrexed Bevacizumab plus Atezolizumab in patients with non-small cell lung carcinoma locally advanced mutated in EGFR
26 patients will be enrolled in this trial to evaluate the major pathologic response in patients with neoadjuvant treatment with Carboplatin Pemetrexed Bevacizumab plus Atezolizumab in patients with non-small cell lung carcinoma locally advanced mutated in EGFR
Detailed Description:
This is an open-label non-randomised phase II multi-centre clinical trial Patients enrolled will receive Atezolizumab 1200mg Bevacizumab 15mgKg Carboplatin AUC6 Pemetrexed 500mgm2 for 3 cycles every 21 days - 3 days as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Atezolizumab 1200 mg Q4W - 3 days
The primary objective is to evaluate the major pathologic response defined as 10 percent or fewer viable cancer cells detectable in the resected tumor and in lymph nodes in stage IIIA EGFR mutated patients treated in neoadjuvant setting with atezolizumab- bevacizumab- carboplatin and pemetrexed
Patient accrual is expected to be completed within 2 years excluding a run-in-period of 3-6 months Treatment and follow-up are expected to extend the study duration to a total of 6 years Patients will be followed 3 years after adjuvant treatment The study will end once survival follow-up has concluded This will be followed by a close out period of 4 months
The primary objective is to evaluate the major pathologic response defined as 10 percent or fewer viable cancer cells detectable in the resected tumor and in lymph nodes in stage IIIA EGFR mutated patients treated in neoadjuvant setting with atezolizumab- bevacizumab- carboplatin and pemetrexed
Patient accrual is expected to be completed within 2 years excluding a run-in-period of 3-6 months Treatment and follow-up are expected to extend the study duration to a total of 6 years Patients will be followed 3 years after adjuvant treatment The study will end once survival follow-up has concluded This will be followed by a close out period of 4 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000642-33 | EUDRACT_NUMBER | None | None |