A Study of Local Ablative Therapy (LAT) in People With Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Minimal Residual DiseaseNon Small Cell Lung Cancer MetastaticNon-small Cell Lung CancerNsclcMetastatic Non Small Cell Lung CancerNSCLC Stage IV
- Interventions
- Procedure: Local ablative therapyOther: Blood collection to assess for ctDNA
- Registration Number
- NCT05429320
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part I Local ablative therapy 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. Part I Blood collection to assess for ctDNA 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. Part II - standard of care Blood collection to assess for ctDNA 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. Part II - ablation to all sites of disease (experimental arm) Local ablative therapy 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. Part II - ablation to all sites of disease (experimental arm) Blood collection to assess for ctDNA 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival/PFS 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.
Measure the reduction in mean variant allele frequency/VAF by 6 months after Local Ablative Therapy/LAT 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
🇺🇸Harrison, New York, United States
Hartford Healthcare ALLIANCE (Data collection only)
🇺🇸Hartford, Connecticut, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
🇺🇸Commack, New York, United States
BAPTIST ALLIANCE - MCI (Data collection only)
🇺🇸Miami, Florida, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
🇺🇸Uniondale, New York, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
🇺🇸Basking Ridge, New Jersey, United States