Actively Recruiting
Alectinib Followed by Concomitant Consolidation SBRT/Hypofractionated Radiation Therapy/SRS in Advanced NSCLC With ALK-rearrangement
Led by Karolinska University Hospital · Updated on 2023-10-10
70
Participants Needed
1
Research Sites
365 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
Researchers are evaluating the safety and effectiveness of adding radiation therapy to all tumor lesions alongside first-line treatment with alectinib in patients with advanced non-small cell lung cancer (NSCLC) that has ALK gene rearrangements. This phase I/II trial aims to determine if this combination is safe and whether it can delay disease progression in patients who have responded to initial alectinib treatment. Participants first receive 2-3 months of alectinib treatment. Those showing stable disease or partial response then undergo consolidation radiation therapy to all known active tumor lesions using stereotactic body radiation therapy (SBRT), stereotactic radiosurgery (SRS), or moderately hypofractionated radiation therapy while continuing alectinib. Treatment continues until disease progression, unacceptable side effects, or other criteria require stopping. During the study, participants are closely monitored for safety and treatment effects. Researchers assess toxicity up to 6 months after radiation and track progression-free survival at 12 months after starting alectinib. Other outcomes include overall survival, time to treatment failure, and time to next therapy over several years. Patients undergo imaging scans, laboratory tests, and clinical evaluations throughout their participation, which may last several years depending on outcomes.
CONDITIONS
Brief 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 non-small cell lung cancer (NSCLC)
- Stage IV NSCLC OR Stage III NSCLC not suitable for surgery or radiochemotherapy OR recurrent NSCLC not amenable to curative multimodal therapy
- Presence of ALK gene rearrangement
- Adequate organ function and clinical tolerance to alectinib
- Stable disease or partial response after 2-3 months of alectinib induction treatment
- Maximum of 5 active tumor lesions with or without thoracic lymph nodes on PET scan after induction
- All active tumor lesions must be treatable with radiation therapy as specified
- Adequate organ function to tolerate radiation therapy and adherence to dose constraints
- ECOG performance status between 0 and 2
- Forced expiratory volume in 1 second (FEV1) of at least 1 litre if lung lesions are targeted
- Age 20 years or older
- Measurable lesions according to RECIST version 1.1
- Signed informed consent
You will not qualify if you...
- Presence of leptomeningeal carcinomatosis
- Persistent malignant pleural, pericardial effusion, or malignant ascites after induction treatment
- Progressive disease after 2-3 months of alectinib induction
- Prior treatment with TKI, chemotherapy, or immunotherapy for metastatic NSCLC (except adjuvant chemotherapy for early stage NSCLC)
- Previous radiation therapy for NSCLC or any other cancer within the last 3 years that could interfere with planned radiation
- Life expectancy less than 6 months
- Inability to understand study information or 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 required
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 3 months
Participants receive alectinib treatment for 2 to 3 months to assess response before radiation therapy.
Visits as per standard clinical care during induction
Duration - Short-term period following induction treatment
Participants receive consolidation radiation therapy (SBRT/SRS/hypofractionated radiation therapy) to all active tumor lesions while continuing alectinib treatment.
Approximately 1 to 2 visits for radiation therapy sessions
Duration - Up to disease progression or discontinuation
Participants continue alectinib treatment until disease progression, unacceptable toxicity, or another discontinuation criterion is met.
Regular visits for ongoing clinical assessments as per routine care
Duration - Up to 5 years post treatment initiation
Participants are monitored for safety and progression-free survival after radiation therapy and during continued alectinib treatment.
Periodic follow-up visits for up to 5 years
Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Stockholm, Sweden, 171 76
Actively Recruiting
Research Team
K
Karin Lindberg, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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