Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-31 @ 1:42 AM
Study NCT ID:
NCT06206850
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2023-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neo-Bio-ADAURA: a Phase II Study to Evaluate Mechanisms of Resistance to Neoadjuvant Osimertinib
Sponsor:
Jair Bar, M.D., Ph.D.
Organization:
Study Overview
Official Title:
Neo-Bio-ADAURA: a Single Arm, Multi-Centre Phase II Study to Evaluate Mechanisms of Resistance to Neoadjuvant Osimertinib.
Status:
RECRUITING
Status Verified Date:
2024-01
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:
This study is a single-arm phase II study of neoadjuvant osimertinib as monotherapy for the treatment of patients with resectable stage II-III non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) sensitizing mutation (L858R or deletion in exon 19 \[Ex19del\]).
Detailed Description:
This study is a single-arm phase II study of neoadjuvant osimertinib as monotherapy (or in combination with chemotherapy-to be considered only if the interim analysis of the ongoing NeoADAURA study would indicate futility of single-agent osimertinib) for the treatment of patients with resectable stage II-III non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) sensitizing mutation (L858R or deletion in exon 19 \[Ex19del\]). Twenty subjects will be included in the study. Potential participants diagnosed with resectable (clinical stage II to IIIB) NSCLC will undergo pre-screening to identify if they carry an EGFR common mutation (Ex19del and/or L858R) - histologically or cytologically. Eligible subjects will receive neoadjuvant osimertinib 80 mg monotherapy once daily (QD) for 9 weeks (3 cycles) followed by surgery (Note: neoadjuvant osimertinib in combination with chemotherapy- will be considered only if the interim analysis of the ongoing NeoADAURA study would indicate futility of single-agent osimertinib). Osimertinib will be continued up to surgery. After surgery, outside of the study protocol the subjects may continue receiving osimertinib 80 mg QD for three years as adjuvant therapy (per local reimbursement), and/or other adjuvant therapy according to relevant standard of care (SoC; platinum + pemetrexed) until disease progression or death. The subjects will be followed up for safety (30 days after the surgery as part of the current protocol's assessments) and survival status (data to be collected as part of SOC, up to 5 years after the last dose of osimertinib).
Tumour specimens will be used for correlative studies to identify molecular mechanisms of tumour resistance to treatment. If available, formalin-fixed paraffin embedded (FFPE) tumour biopsies will be collected at baseline. Resected tumour specimens will be collected during surgery. When possible, recurrence FFPE tumour biopsies will also be collected.
Tumour specimens will be used for correlative studies to identify molecular mechanisms of tumour resistance to treatment. If available, formalin-fixed paraffin embedded (FFPE) tumour biopsies will be collected at baseline. Resected tumour specimens will be collected during surgery. When possible, recurrence FFPE tumour biopsies will also be collected.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: