Non-small Cell Lung CancerPhase 2NCT05429320
A Study of Local Ablative Therapy (LAT) in People With Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Local ablative therapy and Blood collection to assess for ctDNA in people with Non-small Cell Lung Cancer and Metastatic Non Small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial summary
The purpose of this study is to see whether receiving local ablative therapy (LAT) when minimal residual disease/MRD levels are rising can reduce MRD levels and control metastatic non-small cell lung cancer/NSCLC longer compared to systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer, Nsclc
- What is being tested?
- Local ablative therapy and Blood collection to assess for ctDNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 9 sitesUnited States
- Study dates
- 15 Jun 2022to 28 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- At the time of therapeutic phase enrollment, complete response radiographically (no lesions to target)
- Patients with CNS-only disease (due to limited capacity of peripheral blood ctDNA to detect CNS lesions)
- Planned treatment by targeted agents (e.g. tyrosine kinase inhibitors) or patient not a candidate for systemic therapy
- Serious medical co-morbidities precluding radiotherapy or ablation, determined at the discretion of the treating investigator.
- At the time of therapeutic phase enrollment, pregnant or lactating women.
- Physical limitation to undergo stereotactic radiotherapy.
- Other active malignancy within the last year except for basal cell carcinoma of the skin and in situ malignancy even if without evidence of disease.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Hartford Healthcare ALLIANCE (Data collection only)
Hartford, Connecticut, 06102
BAPTIST ALLIANCE - MCI (Data collection only)
Miami, Florida, 33143
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: A Phase II Adaptive Study of Local Ablative Therapy (LAT) for Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Using Minimal Residual Disease (MRD) as an Integral Biomarker
The purpose of this study is to see whether receiving local ablative therapy (LAT) when minimal residual disease/MRD levels are rising can reduce MRD levels and control metastatic non-small cell lung cancer/NSCLC longer compared to systemic therapy.
- Conditions
- Non-small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer, Nsclc, NSCLC Stage IV, Minimal Residual Disease, Non Small Cell Lung Cancer Metastatic
- Being tested
- Local ablative therapy, Blood collection to assess for ctDNA
- Keywords
- Non-small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Metastatic Non Small Cell Lung Cancer, NSCLC, NSCLC Stage IV, Minimal Residual Disease, MRD, 21-465, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local ablative therapyProcedure or surgery
Also called LAT
In part I, 33 patients with metastatic NSCLC with: a) NR-VAF but b) without radiographic progression of disease, will be treated with LAT. In Part II of the study, patients will be randomized to standard of care (continuation of systemic therapy) vs. LAT to all sites of disease
Blood collection to assess for ctDNAOther
Participants will undergo ctDNA collection in conjunction with their standard of care therapy.
| Study group | Role | What they receive |
|---|---|---|
| Part I | Experimental | In part I, 33 patients with metastatic NSCLC with: a) NR-VAF but b) without radiographic progression of disease, will be treated with LAT to determine if ablation to all sites of disease leads to acceptable rates of mean VAF reduction, thus indicating a discernible molecular/clinical response in this subgroup of patients with metastatic disease. Receives: Procedure: Local ablative therapy; Other: Blood collection to assess for ctDNA |
| Part II - standard of care | Active comparator | If the appropriate criteria are met in part I,, in part II 60 patients with NR-VAF but without radiographic progression of disease will be randomized to one of two arms: continuation of systemic therapy (standard of care) vs. ablation to all sites of disease (experimental arm), with a primary endpoint of progression free survival. Receives: Other: Blood collection to assess for ctDNA |
| Part II - ablation to all sites of disease (experimental arm) | Experimental | If the appropriate criteria are met in part I,, in part II 60 patients with NR-VAF but without radiographic progression of disease will be randomized to one of two arms: continuation of systemic therapy (standard of care) vs. ablation to all sites of disease (experimental arm), with a primary endpoint of progression free survival. Receives: Procedure: Local ablative therapy; Other: Blood collection to assess for ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the reduction in mean variant allele frequency/VAF by 6 months after Local Ablative Therapy/LAT
To determine whether Local Ablative Therapy/LAT (ablation to all sites of disease) causes a reduction in mean variant allele frequency/VAF by 6 months after LAT in patients with metastatic NSCLC who have non-responding variant allele frequency/NR-VAF (<50% reduction in mean VAF) but no radiographic progression of disease. Mean VAF: Mean VAF will be defined by the VAF of each relevant mutation divided by the total number of mutations
Measured: 6 months
Progression Free Survival/PFS
PFS will be evaluated through imaging obtained Q3 months +/-2 weeks after enrollment. Progression will be evaluated by RECIST 1.1 guidelines. To determine whether LAT improves PFS in patients with metastatic NSCLC who have NR-VAF but no radiographic progression of disease compared to patients who continue systemic therapy.
Measured: 3 months +/- 2 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start15 Jun 2022
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Gomez, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429320
- Sponsor's protocol ID
- 21-465
- Status last verified
- Jan 2026
- First submitted
- 15 Jun 2022
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Adaptive Study of Local Ablative Therapy (LAT) for Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Using Minimal Residual Disease (MRD) as an Integral Biomarker
- ClinicalTrials.gov ID
- NCT05429320
- Acronym / sponsor ID
- 21-465
- Conditions
- Non-small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer, Nsclc, NSCLC Stage IV, Minimal Residual Disease, Non Small Cell Lung Cancer Metastatic
- Keywords
- Non-small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Metastatic Non Small Cell Lung Cancer, NSCLC, NSCLC Stage IV, Minimal Residual Disease, MRD, 21-465
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 23 Jun 2022 (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 purpose of this study is to see whether receiving local ablative therapy (LAT) when minimal residual disease/MRD levels are rising can reduce MRD levels and control metastatic non-small cell lung cancer/NSCLC longer compared to systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I | Experimental | Procedure: Local ablative therapy, Other: Blood collection to assess for ctDNAIn part I, 33 patients with metastatic NSCLC with: a) NR-VAF but b) without radiographic progression of disease, will be treated with LAT to determine if ablation to all sites of disease leads to acceptable rates of mean VAF reduction, thus indicating a discernible molecular/clinical response in this subgroup of patients with metastatic disease. |
| Part II - standard of care | Active comparator | Other: Blood collection to assess for ctDNAIf the appropriate criteria are met in part I,, in part II 60 patients with NR-VAF but without radiographic progression of disease will be randomized to one of two arms: continuation of systemic therapy (standard of care) vs. ablation to all sites of disease (experimental arm), with a primary endpoint of progression free survival. |
| Part II - ablation to all sites of disease (experimental arm) | Experimental | Procedure: Local ablative therapy, Other: Blood collection to assess for ctDNAIf the appropriate criteria are met in part I,, in part II 60 patients with NR-VAF but without radiographic progression of disease will be randomized to one of two arms: continuation of systemic therapy (standard of care) vs. ablation to all sites of disease (experimental arm), with a primary endpoint of progression free survival. |
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)
- At the time of therapeutic phase enrollment, complete response radiographically (no lesions to target)
- Patients with CNS-only disease (due to limited capacity of peripheral blood ctDNA to detect CNS lesions)
- Planned treatment by targeted agents (e.g. tyrosine kinase inhibitors) or patient not a candidate for systemic therapy
- Serious medical co-morbidities precluding radiotherapy or ablation, determined at the discretion of the treating investigator.
- At the time of therapeutic phase enrollment, pregnant or lactating women.
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 |
|---|---|---|
| Local ablative therapyAlso: LATIn part I, 33 patients with metastatic NSCLC with: a) NR-VAF but b) without radiographic progression of disease, will be treated with LAT. In Part II of the study, patients will be randomized to standard of care (continuation of systemic therapy) vs. LAT to all sites of disease | Procedure or surgery | Part I, Part II - ablation to all sites of disease (experimental arm) |
| Blood collection to assess for ctDNAParticipants will undergo ctDNA collection in conjunction with their standard of care therapy. | Other | Part I, Part II - ablation to all sites of disease (experimental arm), Part II - standard of care |
Primary outcome
Measure the reduction in mean variant allele frequency/VAF by 6 months after Local Ablative Therapy/LAT
Time frame: 6 months
To determine whether Local Ablative Therapy/LAT (ablation to all sites of disease) causes a reduction in mean variant allele frequency/VAF by 6 months after LAT in patients with metastatic NSCLC who have non-responding variant allele frequency/NR-VAF (<50% reduction in mean VAF) but no radiographic progression of disease. Mean VAF: Mean VAF will be defined by the VAF of each relevant mutation divided by the total number of mutations
Progression Free Survival/PFS
Time frame: 3 months +/- 2 weeks after enrollment
PFS will be evaluated through imaging obtained Q3 months +/-2 weeks after enrollment. Progression will be evaluated by RECIST 1.1 guidelines. To determine whether LAT improves PFS in patients with metastatic NSCLC who have NR-VAF but no radiographic progression of disease compared to patients who continue systemic therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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. This study is not recruiting at the moment.
Daniel Gomez, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Local ablative therapy and Blood collection to assess for ctDNA in people with Non-small Cell Lung Cancer and Metastatic Non Small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 9 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: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the reduction in mean variant allele frequency/VAF by 6 months after Local Ablative Therapy/LAT (time frame: 6 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 2 Feb 2026.