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Local Ablative Therapy for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Daniel Gomez, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No serious medical co-morbidities precluding radiotherapy or ablation

Ten or less metastatic lesions amenable to local ablative therapy (LAT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months +/- 2 weeks after enrollment

Awards & highlights

Study Summary

This trial will test whether a treatment that ablates (destroys) cancer cells when MRD levels are rising can control metastatic NSCLC better than systemic therapy.

Who is the study for?

This trial is for adults over 18 with Stage IV NSCLC who've had up to four cycles of standard therapy, have measurable disease but not more than ten lesions, and no active cancers in the last year. They must be able to undergo radiotherapy, not be pregnant or breastfeeding, and have adequate organ function.Check my eligibility

What is being tested?

The study tests if local ablative therapy (LAT) can lower minimal residual disease levels and control metastatic NSCLC better than systemic therapy when MRD levels are rising. Blood will also be collected to check for circulating tumor DNA.See study design

What are the potential side effects?

Local ablative therapy may cause side effects such as pain at the treatment site, fatigue, skin reactions like redness or blistering, shortness of breath, and other tissue-specific complications depending on where it's applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I don't have serious health issues that would prevent me from getting radiotherapy or ablation.

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I have 10 or fewer cancer spots that can be targeted with local treatment.

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I am 18 years old or older.

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I have at least one tumor that can be measured.

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I can safely undergo focused radiation treatment.

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My stage IV lung cancer shows signs in my blood tests.

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My cancer has not spread to the brain only.

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I am not scheduled for targeted therapy or considered for systemic treatment.

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I am not able to become pregnant or I have a negative pregnancy test.

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I am able to get out of my bed or chair and move around.

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My organs are healthy enough for targeted radiation therapy.

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I have completed at least 2 cycles of my first cancer treatment and am still on it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months +/- 2 weeks after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months +/- 2 weeks after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months +/- 2 weeks after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure the reduction in mean variant allele frequency/VAF by 6 months after Local Ablative Therapy/LAT

Progression Free Survival/PFS

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Part II - ablation to all sites of disease (experimental arm)Experimental Treatment2 Interventions

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.

Group II: Part IExperimental Treatment2 Interventions

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.

Group III: Part II - standard of careActive Control1 Intervention

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,744 Total Patients Enrolled

Daniel Gomez, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

90 Total Patients Enrolled

Media Library

Local ablative therapy Clinical Trial Eligibility Overview. Trial Name: NCT05429320 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Part I, Part II - standard of care, Part II - ablation to all sites of disease (experimental arm)

Non-Small Cell Lung Cancer Clinical Trial 2023: Local ablative therapy Highlights & Side Effects. Trial Name: NCT05429320 — Phase 2

Local ablative therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05429320 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned local ablative therapy?

"Local ablative therapy has been given a safety rating of 2 due to the limited data available from Phase 2 trials, which only support its safety rather than its efficacy."

Answered by AI

How many participants are being included in this research program?

"Affirmative. According to clinicaltrials.gov, this research study is actively searching for volunteers and was posted on June 15th 2022 with its last update made November 17th 2022. A total of 117 subjects need to be enrolled from 7 different medical centres."

Answered by AI

How many health centers are currently participating in this experiment?

"Patients can now enroll in this clinical trial at Memorial Sloan Kettering Westchester (Limited Protocol Activities) located in Harrison, as well as the New york and Basking Ridge branches of Memorial Sloan Kettering Cancer Center. Additionally, there are 7 other recruiting locations throughout the United States."

Answered by AI

Are there any current opportunities to join this clinical trial?

"Affirmative. According to the details available on clinicaltrials.gov, this medical trial which was initially posted on June 15th 2022 is actively searching for 117 participants spread across 7 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Local Ablative Therapy (LAT) in People With Non-Small Cell Lung Cancer (NSCLC)

2022. "A Study of Local Ablative Therapy (LAT) in People With Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429320.

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