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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)

Must not have

Serious medical co-morbidities precluding radiotherapy or ablation

Physical limitation to undergo stereotactic radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months +/- 2 weeks after enrollment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have health issues that prevent me from receiving radiation or ablation treatments.

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I cannot have stereotactic radiotherapy due to physical limitations.

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I haven't had any cancer in the last year except for skin cancer or localized cancer that hasn't spread.

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I am set to receive targeted therapy or am not eligible for systemic therapy.

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Progression Free Survival/PFS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 18Eligibility criteria met