A-SAB - Alectinib Followed by Concomitant Consolidation SBRT/Hypofractionated Radiation Therapy/SRS in Advanced NSCLC With ALK-rearrangement
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.
• 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