Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorKarolinska University Hospital

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

70 Participants
are divided into 1 treatment group

Sponsors and collaborators

Karolinska University Hospital

Lead sponsor

Sahlgrenska University Hospital

Collaborator