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.
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
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
Single group
SBRT/SRS/radiation therapy
RadiationConsolidation radiation therapy (SBRT/SRS/moderately hypofractionated radiation therapy)
Toxicity (safety)
No and percentage of patients suffering grade 3-5 toxicity attributed to RT and within 6 months post RT).
Progression free survival (PFS)
PFS-rate at 12 months (KM-estimated method). Successrate is 12-month-PFS-rate of 85%. Median PFS will also be measured
Overall survival
OS-rate at 1-, 2-, 3- and 5 years post initiation of alectinib using the KM-method. Median OS will also be measured.
Progression free survival II
(Time between the date of initiation of alectinib and the date of documented 2nd tumour progression or death, from whatever reason.) PFS II rate at 1-, 2-, 3- and 5 years (KM-method) will be measured.
Time to treatment failure
Time between the date of initiation of alectinib and the date of documented progressive disease, unacceptable toxicity related to SBRT, toxicity attributed to alectinib leading to interruption of the treatment or death. (Time between the date of initiation of alectinib and the date of documented 2nd tumour progression or death, from whatever reason.) TTF-rate at 1-, 2-, 3- and 5 years (KM-method).
Time to next therapy
Time between the date of initiation of alectinib and the date of next therapy. (Time between the date of initiation of alectinib and the date of documented 2nd tumour progression or death, from whatever reason.) Rate at 1-, 2-, 3- and 5 years (KM-method).
Translational biomarker studies
For plasma samples: extracellular vesicles isolated from plasma are profiled for protein and RNA expression with linkage to clinical response and tumor marker expression.
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Karolinska University Hospital
Lead sponsor
Sahlgrenska University Hospital
Collaborator
