NCT05724004Recruiting
Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)
A-SAB - Alectinib Followed by Concomitant Consolidation SBRT/Hypofractionated Radiation Therapy/SRS in Advanced NSCLC With ALK-rearrangement
Source: ClinicalTrials.gov · Last updated 10 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 20 Jan 2023
- Start date
- 5 Oct 2023
- Primary completion date
- 20 Jun 2024
- Lead sponsor
- Karolinska University Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05724004
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 5 Oct 2023 to the primary completion date, 20 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.