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

Phase 2

Recruiting

• Conditions: Minimal Residual Disease; Non Small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer; Nsclc; Metastatic Non Small Cell Lung Cancer; NSCLC Stage IV

• 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

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-23
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-06
• Primary Completion: 2026-06-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

• 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

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

Trial Locations

Locations (9)

Hartford Healthcare ALLIANCE (Data collection only); 🇺🇸 Hartford, Connecticut, United States

BAPTIST ALLIANCE - MCI (Data collection only); 🇺🇸 Miami, Florida, United States

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States