Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)
NCT05724004 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2023-10-10
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.
Conditions
- Radiotherapy Side Effect
- Non-small Cell Lung Cancer
- ALK Gene Mutation
Interventions
- RADIATION
-
SBRT/SRS/radiation therapy
Consolidation radiation therapy (SBRT/SRS/moderately hypofractionated radiation therapy)
Sponsors & Collaborators
-
Sahlgrenska University Hospital
collaborator OTHER -
Karolinska University Hospital
lead OTHER
Principal Investigators
-
Karin Lindberg, MD, PhD · Karolinska University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-05
- Primary Completion
- 2024-06-20
- Completion
- 2031-06-20
Countries
- Sweden
Study Locations
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