About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- SBRT/SRS/radiation therapy
Treatment groups
Sponsors and collaborators
Karolinska University Hospital
Lead sponsor
Sahlgrenska University Hospital
Collaborator