Lung CancerPhase 1/2DURABLENCT05987644
Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements
A Phase 1/2 study testing Alectinib and Stereotactic Radiosurgery in people with Lung Cancer and NSCLC, run by Joshua Palmer at 3 sites in United States.
Trial summary
This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days. Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, NSCLC, Brain Metastases
- What is being tested?
- Alectinib and Stereotactic Radiosurgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Mar 2024to 28 Feb 2029
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Active infection requiring systemic therapy.
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
- Treatment with any investigational drug within 28 days prior to registration.
- Acute viral, autoimmune, alcoholic, or other types of acute hepatitis.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Colorado Cancer Center
Aurora, Colorado, 80045
Robyn Swing, robyn.swing@cuanschutz.edu
Brian Kavanagh, MD
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Brian Spahnie, brian.spahnie@osumc.edu
Joshua Palmer, MD
- Recruiting
Stanford University
Stanford, California, 94305
Brittany Johnson, brittan5@stanford.edu
Nathaniel Myall, MD
About this study
Official title: DURABLE: Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and rEarrangements
This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days.
Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Those in Phase 2 Arm A will receive alectinib alone. Those in Phase 2, Arm B will receive SRS + alectinib.
A maximum of 25 cycles (2 years) of alectinib may be administered on study.
- Conditions
- Lung Cancer, NSCLC, Brain Metastases
- Being tested
- Alectinib, Stereotactic Radiosurgery
- Medical subject headings
- Lung Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlectinibDrug
600mg taken orally, twice daily for 25 Cycles Cycle = 4 weeks (28 days)
Stereotactic RadiosurgeryRadiation
Also called SRS
SRS dose varies by brain met size and location
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b: Experimental | Experimental | 600mg alectinib taken orally twice daily Receives: Drug: Alectinib |
| Phase 2: Arm A | Experimental | 600mg alectinib taken orally twice daily Receives: Drug: Alectinib |
| Phase 2: Arm B | Experimental | Subjects will receive SRS prior to taking alectinib. 24 hours after, but no more than 7 days after last radiation dose, alectinib should be taken at 600mg orally twice daily Receives: Drug: Alectinib; Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2: Neurological status and control of CNS disease at 12 months compared to alectinib plus SRS in patients with ≤15 CNS metastases
Neurological status will be measured by a composite endpoint of:
-Inntracranial progression(icPD) by RANO-BM criteria or death during the first 12 months.
OR
-Symptomatic radiation necrosis during the first 12 months. Symptomatic radiation necrosis is defined as requiring initiation of or increased dose of steroids or resulting in seizures or requirement of AEDs or requirement of hospitalization or surgery.
OR
-Cognitive decline, defined as 1 standard deviation decline from baseline cognitive function during the first 12 months.
Measured: 12 months
Phase 1b: Safety and Feasibility
Safety and feasibility will be assessed by frequency of Dose Limiting Toxicities.
Measured: 6 months
Secondary outcomes (9)
Intracranial progression-free survival at 12 months (icPFS12)
icPFS12 is the percentage of patients with icPD at 12 months defined by RANO-BM from randomization or death.
Measured: 12 months
Intracranial disease control rate (icDCR)
icDCR defined as the percentage of patients with a complete response (CR), partial response (PR), or stable disease (SD), per RANO-BM.
Measured: 31 months
Intracranial response rate (icRR)
icRR defined as the percentage of patients with a complete response (CR) and partial response (PR), per RANO-BM.
Measured: 31 months
Intracranial duration of response (icDOR)
icDOR defined as the time when the criteria for CR or PR per RANO-BM were first met to the occurrence of an icPFS event
Measured: 31 months
Extracranial PFS
Extracranial PFS will be defined as time from randomization to progression per RECIST v1.1
Measured: 31 months
Assess Overall survival (OS)
OS defined as the time from randomization to death from any cause.
Measured: 31 months
Safety and Tolerability
Safety and tolerability will be assessed by measuring the frequency and severity of adverse events based on CTCAE v5.0
Measured: 6 months
Cognitive decline at 12 and 24 months
Rate of cognitive decline, defined as 1 standard deviation decline from baseline cognitive function in at least 1 cognitive test.
Measured: 12, 24 months
Symptomatic radiation necrosis at 12 and 24 months
Incidence of symptomatic radiation necrosis, defined as requiring initiation of or increased dose of steroids or resulting in seizures or requirement of AEDs or requirement of hospitalization or surgery.
Measured: 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start7 Mar 2024
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua Palmer
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Joshua Palmer, Hoosier Cancer Research Network
- Investigators
- Joshua D Palmer, MD, Principal investigator, The Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987644
- Sponsor's protocol ID
- HCRN-LUN21-534
- Acronym
- DURABLE
- Status last verified
- Apr 2026
- First submitted
- 26 Jul 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DURABLE: Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and rEarrangements
- ClinicalTrials.gov ID
- NCT05987644
- Acronym / sponsor ID
- DURABLE / HCRN-LUN21-534
- Conditions
- Lung Cancer, NSCLC, Brain Metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Joshua PalmerUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 14 Aug 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.
This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days.
Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Those in Phase 2 Arm A will receive alectinib alone. Those in Phase 2, Arm B will receive SRS + alectinib.
A maximum of 25 cycles (2 years) of alectinib may be administered on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1b: Experimental | Experimental | Drug: Alectinib600mg alectinib taken orally twice daily |
| Phase 2: Arm A | Experimental | Drug: Alectinib600mg alectinib taken orally twice daily |
| Phase 2: Arm B | Experimental | Drug: Alectinib, Radiation: Stereotactic RadiosurgerySubjects will receive SRS prior to taking alectinib. 24 hours after, but no more than 7 days after last radiation dose, alectinib should be taken at 600mg orally twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Active infection requiring systemic therapy.
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
- Treatment with any investigational drug within 28 days prior to registration.
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 |
|---|---|---|
| Alectinib600mg taken orally, twice daily for 25 Cycles Cycle = 4 weeks (28 days) | Drug | Phase 1b: Experimental, Phase 2: Arm A, Phase 2: Arm B |
| Stereotactic RadiosurgeryAlso: SRSSRS dose varies by brain met size and location | Radiation | Phase 2: Arm B |
Primary outcome
Phase 2: Neurological status and control of CNS disease at 12 months compared to alectinib plus SRS in patients with ≤15 CNS metastases
Time frame: 12 months
Neurological status will be measured by a composite endpoint of: -Inntracranial progression(icPD) by RANO-BM criteria or death during the first 12 months. OR -Symptomatic radiation necrosis during the first 12 months. Symptomatic radiation necrosis is defined as requiring initiation of or increased dose of steroids or resulting in seizures or requirement of AEDs or requirement of hospitalization or surgery. OR -Cognitive decline, defined as 1 standard deviation decline from baseline cognitive function during the first 12 months.
Phase 1b: Safety and Feasibility
Time frame: 6 months
Safety and feasibility will be assessed by frequency of Dose Limiting Toxicities.
9 secondary outcomes
Intracranial progression-free survival at 12 months (icPFS12)
Time frame: 12 months
Intracranial disease control rate (icDCR)
Time frame: 31 months
Intracranial response rate (icRR)
Time frame: 31 months
Intracranial duration of response (icDOR)
Time frame: 31 months
Extracranial PFS
Time frame: 31 months
Assess Overall survival (OS)
Time frame: 31 months
Safety and Tolerability
Time frame: 6 months
Cognitive decline at 12 and 24 months
Time frame: 12, 24 months
Symptomatic radiation necrosis at 12 and 24 months
Time frame: 12, 24 months
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 8 Apr 2026.
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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.
Joshua D Palmer, MD principal investigator
The Ohio State University Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Alectinib and Stereotactic Radiosurgery in people with Lung Cancer and NSCLC, run by Joshua Palmer at 3 sites in United States.
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 0 inclusion and 7 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Joshua D Palmer, MD (614-293-0871, joshua.palmer@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2: Neurological status and control of CNS disease at 12 months compared to alectinib plus SRS in patients with ≤15 CNS metastases (time frame: 12 months). 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 8 Apr 2026.