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Official title Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)
ClinicalTrials.gov ID: NCT05724004
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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
You likely can't join if
- Leptomeningeal carcinosis (on MRI or in cerebrospinal fluid (CSF))
- Persistent malignant pleural effusion, malignant pericardial effusion or malignant ascites after induction 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
See the full eligibility criteria
- 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
- Leptomeningeal carcinosis (on MRI or in cerebrospinal fluid (CSF))
- Persistent malignant pleural effusion, malignant pericardial effusion or malignant ascites after induction 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
- Life expectancy of less than 6 months
- Inability to understand given information or undergo study procedures according to protocol.
- Has evidence or a past medical history of interstitial lung disease or active, non-infectious pneumonitis or known pulmonary fibrosis.
- Pregnant or breast-feeding. Patients must agree to use safe contraception during and for 3 months after study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.