Radiotherapy Side EffectA-SABNCT05724004
Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)
A study testing SBRT/SRS/radiation therapy in people with Radiotherapy Side Effect and Non-small Cell Lung Cancer, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Radiotherapy Side Effect, Non-small Cell Lung Cancer, ALK Gene Mutation
- What is being tested?
- SBRT/SRS/radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 5 Oct 2023to 20 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- Previous RT for NSCLC (any stage)
- Previous RT for any other cancer within the last 3 years possibly interfering with the planned RT within this study
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- Life expectancy of less than 6 months
- Inability to understand given information or undergo study procedures according to protocol.
- Has evidence or a past medical history of interstitial lung disease or active, non-infectious pneumonitis or known pulmonary fibrosis.
- Pregnant or breast-feeding. Patients must agree to use safe contraception during and for 3 months after study treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 171 76
Katja Tobin, PhD, +46851770000, katja.tobin@regionstockholm.se
Karin Lindberg, MD, PhD
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- SBRT/SRS/radiation therapy
- Keywords
- Stereotactic body radiation therapy, SBRT, Radiotherapy, Non-small Cell Lung Cancer, ALK-rearrangement
- Medical subject headings
- Radiation Injuries, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT/SRS/radiation therapyRadiation
Consolidation radiation therapy (SBRT/SRS/moderately hypofractionated radiation therapy)
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy + alectinib | Experimental | All patients receive consolidation radiation therapy to all active tumour lesions after induction treatment with alectinib. Receives: Radiation: SBRT/SRS/radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity (safety)
No and percentage of patients suffering grade 3-5 toxicity attributed to RT and within 6 months post RT).
Measured: 6 months post radiation therapy
Progression free survival (PFS)
PFS-rate at 12 months (KM-estimated method). Successrate is 12-month-PFS-rate of 85%. Median PFS will also be measured
Measured: PFS rate at 12 months after initiation of alectinib
Secondary outcomes (4)
Overall survival
OS-rate at 1-, 2-, 3- and 5 years post initiation of alectinib using the KM-method. Median OS will also be measured.
Measured: 5 years
Progression free survival II
(Time between the date of initiation of alectinib and the date of documented 2nd tumour progression or death, from whatever reason.) PFS II rate at 1-, 2-, 3- and 5 years (KM-method) will be measured.
Measured: 5 years
Time to treatment failure
Time between the date of initiation of alectinib and the date of documented progressive disease, unacceptable toxicity related to SBRT, toxicity attributed to alectinib leading to interruption of the treatment or death. (Time between the date of initiation of alectinib and the date of documented 2nd tumour progression or death, from whatever reason.) TTF-rate at 1-, 2-, 3- and 5 years (KM-method).
Measured: 3 years
Time to next therapy
Time between the date of initiation of alectinib and the date of next therapy. (Time between the date of initiation of alectinib and the date of documented 2nd tumour progression or death, from whatever reason.) Rate at 1-, 2-, 3- and 5 years (KM-method).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start5 Oct 2023
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, multicenter, phase I/II study
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Karin Lindberg, Karolinska University Hospital
- Investigators
- Karin Lindberg, MD, PhD, Study director, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724004
- Sponsor's protocol ID
- A-SAB
- Acronym
- A-SAB
- Status last verified
- Oct 2023
- First submitted
- 20 Jan 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A-SAB - Alectinib Followed by Concomitant Consolidation SBRT/Hypofractionated Radiation Therapy/SRS in Advanced NSCLC With ALK-rearrangement
- ClinicalTrials.gov ID
- NCT05724004
- Acronym / sponsor ID
- A-SAB / A-SAB
- Keywords
- Stereotactic body radiation therapy, SBRT, Radiotherapy, Non-small Cell Lung Cancer, ALK-rearrangement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2031 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, multicenter, phase I/II study
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy + alectinib | Experimental | Radiation: SBRT/SRS/radiation therapyAll patients receive consolidation radiation therapy to all active tumour lesions after induction treatment with alectinib. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histological or cytological confirmed NSCLC:
- 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
Key exclusion criteria (10 listed)
- 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
- Previous RT for NSCLC (any stage)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT/SRS/radiation therapyConsolidation radiation therapy (SBRT/SRS/moderately hypofractionated radiation therapy) | Radiation | Radiotherapy + alectinib |
Primary outcome
Toxicity (safety)
Time frame: 6 months post radiation therapy
No and percentage of patients suffering grade 3-5 toxicity attributed to RT and within 6 months post RT).
Progression free survival (PFS)
Time frame: PFS rate at 12 months after initiation of alectinib
PFS-rate at 12 months (KM-estimated method). Successrate is 12-month-PFS-rate of 85%. Median PFS will also be measured
4 secondary outcomes
Overall survival
Time frame: 5 years
Progression free survival II
Time frame: 5 years
Time to treatment failure
Time frame: 3 years
Time to next therapy
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karin Lindberg, MD, PhD study director
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT/SRS/radiation therapy in people with Radiotherapy Side Effect and Non-small Cell Lung Cancer, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karin Lindberg, MD, PhD (+46851770000, karin.lindberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity (safety) (time frame: 6 months post radiation therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.