NCT05724004 Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)
| NCT ID | NCT05724004 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska University Hospital |
| Condition | Radiotherapy Side Effect |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-10-05 |
| Primary Completion | 2024-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2023-10-05 with a primary completion date of 2024-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Karin Lindberg, MD, PhD
STUDY DIRECTOR
Karolinska University Hospital
Frequently Asked Questions
Who can join the NCT05724004 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Radiotherapy Side Effect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05724004 currently recruiting?
Yes, NCT05724004 is actively recruiting participants. Contact the research team at karin.lindberg@ki.se for enrollment information.
Where is the NCT05724004 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05724004 clinical trial?
NCT05724004 is sponsored by Karolinska University Hospital. The principal investigator is Karin Lindberg, MD, PhD at Karolinska University Hospital. The trial plans to enroll 70 participants.