Adds radiation therapy to alectinib in advanced ALK-positive lung cancer
Tests radiation added to alectinib in adults with advanced ALK-positive lung cancer.
Key facts
- Who runs it
- Karolinska University Hospital
- Where
- Stockholm, SwedenSee the site
- Trial code
- Registry title
- Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)
- Status
- Recruiting
- People taking part
- 70 people, planned
- Started
- 5 Oct 2023
- Expected to end
- 20 Jun 2031
- Type of study
- Interventional
- Treatments tested
- SBRT/SRS/radiation therapy
- Record updated
- 10 October 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced non-small cell lung cancer with an ALK change who responded to the first 2-3 months of alectinib. Radiation to all remaining tumours is added.
- Age
- 20 years or older
- Sex
- Men and women can join.
- Disease stage
- Stage IV, stage III that cannot be treated with surgery or chemoradiation, or cancer that came back after surgery. After alectinib the disease is stable or partly shrunk, with at most 5 active tumour lesions on a PET scan.
- Earlier treatment
- Must have had 2-3 months of alectinib first. Cannot have had earlier TKI, chemotherapy or immunotherapy for metastatic disease, or earlier radiation for lung cancer.
- Biomarker or test result
- ALK-rearrangement
Main reasons for not taking part
- Cancer spread to the membranes around the brain or spinal cord
- Cancer that grew during the first 2-3 months of alectinib
- Fluid in the lung, heart sac or belly caused by cancer that persists
- Past or current interstitial lung disease, pneumonitis or lung fibrosis
- Pregnant or breast-feeding
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- Histological or cytological confirmed NSCLC:; Stage IV NSCLC OR; Stage III NSCLC not suitable for surgery or radiochemotherapy OR; Recurrent NSCLC after previous surgery (not amendable for curative multimodal therapy)
- ALK-rearrangement
- Adequate organ function to tolerate alectinib and clinical tolerance to alectinib
- Stable disease (SD) or partial response (PR) after 2-3 months induction treatment with alectinib
- Maximum 5 tumour lesions +/- thoracic lymph nodes active on an 18F-FDG-PET scan post induction treatment with alectinib
- All active tumour lesions amendable to RT under the following conditions:; All metastases possible to treat with; Extracranial metastases: SBRT of at least 7 Gy x 5 (corresponding to 50 Gy EQD2 using alfa/beta 10Gy); Intracranial metastases: SRS or f-SRS; The primary tumour and/or lymph nodes and/or pulmonary metastases amendable to SBRT (≥ 7Gy x 5, see above) or moderately hypofractionated RT of 3 Gy x 15 (corresponding to 49 Gy EQD2 using alfa/beta 10Gy)
- Adequate organ function to tolerate SBRT/RT:; Fulfilment of dose constraints to adequate organs at risk
- ECOG performance status (PS) 0-2
- FEV1 ≥1 litre (only applicable for lung targets)
- Age ≥ 20 years
- Measurable lesions according to RECIST v 1.1
- Signed written informed consent
Who cannot take part
- PD after 2-3-month-induction treatment with alectinib
- Previous TKI, chemotherapy or immunotherapy (previous adjuvant chemotherapy for early stage NSCLC is allowed) for metastatic NSCLC
- Previous RT for NSCLC (any stage)
- Previous RT for any other cancer within the last 3 years possibly interfering with the planned RT within this study
- Persistent malignant pleural effusion, malignant pericardial effusion or malignant ascites after induction treatment
- Has evidence or a past medical history of interstitial lung disease or active, non-infectious pneumonitis or known pulmonary fibrosis
- Leptomeningeal carcinosis (on MRI or in cerebrospinal fluid (CSF))
- Life expectancy of less than 6 months
- Inability to understand given information or undergo study procedures according to protocol
- Pregnant or breast-feeding. Patients must agree to use safe contraception during and for 3 months after study treatment
Where in Sweden
- Karolinska University HospitalStockholm, SwedenContact: Katja Tobin, PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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 group in the trial
- Radiotherapy + alectinibTreatment being tested
All patients receive consolidation radiation therapy to all active tumour lesions after induction treatment with alectinib.
Treatment: SBRT/SRS/radiation therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A-SAB - Alectinib Followed by Concomitant Consolidation SBRT/Hypofractionated Radiation Therapy/SRS in Advanced NSCLC With ALK-rearrangement
- Plain-language title
- Adds radiation therapy to alectinib in advanced ALK-positive lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 10 October 2023