RecruitingRecruiting
Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)
NCT05724004 · Karolinska University Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A-SAB - Alectinib Followed by Concomitant Consolidation SBRT/Hypofractionated Radiation Therapy/SRS in Advanced NSCLC With ALK-rearrangement
About this study
This is phase I/II study to evaluate the feasibility (phase I) and progression free survival (phase II) in patients with advanced NSCLC with ALK-rearrangement receiving consolidation radiation therapy (RT) to all known macroscopic tumour lesions present after 2-3 months of treatment with alectinib and then continuing with alectinib.
Eligible patients are those with an ALK-rearranged stage III (non-surgical/non-radiochemotherapy candidates) OR stage IV NSCLC who, after a 2-3-month-induction period of alectinib show stable disease/partial response to systemic therapy. When entering the trial, all known tumour lesions are treated with SBRT/RT/SRS with concomitant alectinib followed by continuation 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.
Study design
Enrollment target: 70 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-05
Estimated completion: 2031-06-20
Last updated: 2023-10-10
Interventions
Radiation: SBRT/SRS/radiation therapy
Primary outcomes
- • Toxicity (safety) (6 months post radiation therapy)
- • Progression free survival (PFS) (PFS rate at 12 months after initiation of alectinib)
Sponsor
Karolinska University Hospital · other
With: Sahlgrenska University Hospital
Contacts & investigators
ContactKarin Lindberg, MD, PhD · contact · karin.lindberg@ki.se · +46851770000
InvestigatorKarin Lindberg, MD, PhD · study_director, Karolinska University Hospital
All locations (1)
Karolinska University HospitalRecruiting
Stockholm, Sweden