Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05724004
Status:
RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-01-20
Brief Title:
Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement A-SAB
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
A-SAB - Alectinib Followed by Concomitant Consolidation SBRTHypofractionated Radiation TherapySRS in Advanced NSCLC With ALK-rearrangement
Status:
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:
A-SAB
Brief Summary:
The goal of this clinical trial is to learn evaluate the safety and efficacy of the addition of radiation therapy to all tumour lesions to first line medical treatment with alectinib in non-small cell lung cancer harbouring ALK-rearrangements
The main aims of the trial are to evaluate
if the treatment combination is safe
if the treatment combination can inhibit progression
Participants who have responded to 1st line alectinib will be treated with consolidation radiation therapy to all remaining tumour lesions while continuing on alectinib until disease progression unacceptable toxicity or another discontinuation criterion is met
The main aims of the trial are to evaluate
if the treatment combination is safe
if the treatment combination can inhibit progression
Participants who have responded to 1st line alectinib will be treated with consolidation radiation therapy to all remaining tumour lesions while continuing on alectinib until disease progression unacceptable toxicity or another discontinuation criterion is met
Detailed Description:
This is phase III study to evaluate the feasibility phase I and progression free survival phase II in patients with advanced NSCLC with ALK-rearrangement receiving consolidation radiation therapy RT to all known macroscopic tumour lesions present after 2-3 months of treatment with alectinib and then continuing with alectinib
Eligible patients are those with an ALK-rearranged stage III non-surgicalnon-radiochemotherapy candidates OR stage IV NSCLC who after a 2-3-month-induction period of alectinib show stable diseasepartial response to systemic therapy When entering the trial all known tumour lesions are treated with SBRTRTSRS with concomitant alectinib followed by continuation alectinib until disease progression unacceptable toxicity or another discontinuation criterion is met
Eligible patients are those with an ALK-rearranged stage III non-surgicalnon-radiochemotherapy candidates OR stage IV NSCLC who after a 2-3-month-induction period of alectinib show stable diseasepartial response to systemic therapy When entering the trial all known tumour lesions are treated with SBRTRTSRS with concomitant alectinib followed by continuation alectinib until disease progression unacceptable toxicity or another discontinuation criterion is met
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