Actively Recruiting
Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)
Led by Karolinska University Hospital · Updated on 2023-10-10
70
Participants Needed
1
Research Sites
402 weeks
Total Duration
On this page
Sponsors
K
Karolinska University Hospital
Lead Sponsor
S
Sahlgrenska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed NSCLC with either stage IV, stage III not suitable for surgery or radiochemotherapy, or recurrent NSCLC after surgery not amenable to curative therapy
- ALK gene rearrangement present
- Adequate organ function and clinical tolerance for alectinib
- Stable disease or partial response after 2-3 months induction treatment with alectinib
- Maximum of 5 tumor lesions plus or minus thoracic lymph nodes active on 18F-FDG-PET scan after induction treatment
- All active tumor lesions suitable for radiation therapy as defined, including SBRT or SRS protocols
- Fulfillment of dose constraints to protect organs at risk for radiation therapy
- ECOG performance status of 0 to 2
- Forced expiratory volume in 1 second (FEV1) of at least 1 liter for lung targets
- Age 20 years or older
- Measurable lesions according to RECIST version 1.1
- Signed written informed consent
You will not qualify if you...
- Presence of leptomeningeal carcinomatosis by MRI or cerebrospinal fluid analysis
- Persistent malignant pleural, pericardial effusion, or malignant ascites after induction treatment
- Progressive disease after 2-3 months induction treatment with alectinib
- Previous treatment with tyrosine kinase inhibitors, chemotherapy, or immunotherapy for metastatic NSCLC (except adjuvant chemotherapy for early stage)
- Previous radiation therapy for NSCLC of any stage
- Radiation therapy for any other cancer within the last 3 years that may interfere with planned study radiation
- Life expectancy less than 6 months
- Inability to understand study information or comply with protocol procedures
- History or evidence of interstitial lung disease, active non-infectious pneumonitis, or known pulmonary fibrosis
- Pregnant or breastfeeding; agreement to use safe contraception during and for 3 months after study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Stockholm, Sweden, 171 76
Actively Recruiting
Research Team
K
Karin Lindberg, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here