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RECRUITING

NCT05724004

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

Sponsor: Karolinska University Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-10-05

Completion Date

2031-06-20

Last Updated

2023-10-10

Healthy Volunteers

Conditions

Radiotherapy Side Effect Non-small Cell Lung Cancer ALK Gene Mutation

Interventions

RADIATION

SBRT/SRS/radiation therapy

Consolidation radiation therapy (SBRT/SRS/moderately hypofractionated radiation therapy)

Inclusion Criteria: 1. 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) 2. ALK-rearrangement 3. Adequate organ function to tolerate alectinib and clinical tolerance to alectinib 4. Stable disease (SD) or partial response (PR) after 2-3 months induction treatment with alectinib 5. Maximum 5 tumour lesions +/- thoracic lymph nodes active on an 18F-FDG-PET scan post induction treatment with alectinib 6. 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) 7. Adequate organ function to tolerate SBRT/RT: * Fulfilment of dose constraints to adequate organs at risk 8. ECOG performance status (PS) 0-2 9. FEV1 ≥1 litre (only applicable for lung targets) 10. Age ≥ 20 years 11. Measurable lesions according to RECIST v 1.1 12. Signed written informed consent Exclusion Criteria: 1. Leptomeningeal carcinosis (on MRI or in cerebrospinal fluid (CSF)) 2. Persistent malignant pleural effusion, malignant pericardial effusion or malignant ascites after induction treatment 3. PD after 2-3-month-induction treatment with alectinib 4. Previous TKI, chemotherapy or immunotherapy (previous adjuvant chemotherapy for early stage NSCLC is allowed) for metastatic NSCLC 5. Previous RT for NSCLC (any stage) 6. Previous RT for any other cancer within the last 3 years possibly interfering with the planned RT within this study 7. Life expectancy of less than 6 months 8. Inability to understand given information or undergo study procedures according to protocol. 9. Has evidence or a past medical history of interstitial lung disease or active, non-infectious pneumonitis or known pulmonary fibrosis. 10. Pregnant or breast-feeding. Patients must agree to use safe contraception during and for 3 months after study treatment.

Locations (1)

Karolinska University Hospital

Stockholm, Sweden