Local Ablative Therapy for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Platinum-doublet chemotherapy, ICI
Must not be taking: Targeted agents
Disqualifiers: CNS-only disease, Serious comorbidities, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have received at least two cycles of first-line systemic therapy and remain on it, suggesting that you may continue your current treatment.
What data supports the effectiveness of this treatment for non-small cell lung cancer?
Research shows that stereotactic body radiation therapy (SBRT), also known as stereotactic ablative radiotherapy (SABR), is a safe and effective treatment for early-stage non-small cell lung cancer (NSCLC), especially for patients who cannot undergo surgery. It offers good local control and outcomes similar to surgery, with low toxicity for tumors located away from sensitive structures.
12345Is local ablative therapy for non-small cell lung cancer safe?
Local ablative therapy, also known as stereotactic ablative radiotherapy (SABR), is generally safe for treating lung tumors, especially when they are small and not near critical structures. However, there is a risk of serious complications if the tumors are close to important areas like the bronchial tree or mediastinum (the area between the lungs).
46789How is the treatment for non-small cell lung cancer different from other treatments?
Local ablative therapy, also known as stereotactic ablative radiotherapy (SABR) or stereotactic body radiation therapy (SBRT), is unique because it delivers high doses of radiation with precision over a few sessions, making it a noninvasive option for patients who cannot undergo surgery. It is particularly effective for early-stage non-small cell lung cancer and offers similar local control to surgery with relatively low toxicity.
34101112Eligibility Criteria
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.Inclusion Criteria
I've had up to 4 rounds of initial cancer treatment.
I don't have serious health issues that would prevent me from getting radiotherapy or ablation.
I had imaging tests done within 4 weeks of my blood test for cancer DNA.
+17 more
Exclusion Criteria
I have health issues that prevent me from receiving radiation or ablation treatments.
I cannot have stereotactic radiotherapy due to physical limitations.
I haven't had any cancer, except for skin cancer, in the last 5 years.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Part I
Participants with metastatic NSCLC receive Local Ablative Therapy (LAT) to determine if ablation to all sites of disease leads to acceptable rates of mean VAF reduction.
6 months
Treatment Part II
Participants are randomized to either continuation of systemic therapy or ablation to all sites of disease, with a primary endpoint of progression-free survival.
3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, with imaging obtained every 3 months.
6 months
Participant Groups
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.
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
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.
Local ablative therapy is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Local ablative therapy for:
- Non-small cell lung cancer (NSCLC)
- Oligometastatic NSCLC
🇺🇸 Approved in United States as Local ablative therapy for:
- Non-small cell lung cancer (NSCLC)
- Oligometastatic NSCLC
🇨🇦 Approved in Canada as Local ablative therapy for:
- Non-small cell lung cancer (NSCLC)
- Oligometastatic NSCLC
🇯🇵 Approved in Japan as Local ablative therapy for:
- Non-small cell lung cancer (NSCLC)
- Oligometastatic NSCLC
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hartford Healthcare ALLIANCE (Data collection only)Hartford, CT
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, NJ
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)Commack, NY
Baptist Alliance - McIMiami, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Stereotactic body radiation therapy for early-stage primary lung cancer, is an active breath coordinator necessary? An audit from a tertiary cancer care center. [2018]The hypofractionated stereotactic body radiation therapy (SBRT) has emerged as a safe and effective treatment modality for early-stage nonsmall cell lung carcinoma.
Comparison of accelerated hypofractionation and stereotactic body radiotherapy for Stage 1 and node negative Stage 2 non-small cell lung cancer (NSCLC). [2022]Stereotactic body radiation therapy (SBRT) and accelerated hypofractionated radiation therapy (AHRT) have favorable local control (LC) relative to conventional fractionation in the treatment of stage I non-small cell lung cancer (NSCLC). We report the results of our single institution experience with the treatment of early stage NSCLC with SBRT or AHRT in cases where SBRT was felt to be suboptimal.
Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]Stereotactic ablative radiotherapy (SABR), otherwise known as stereotactic body radiation therapy (SBRT), is an external beam treatment modality that offers the ability to deliver with high precision large doses of radiation over a limited number of fractions. SABR is currently a standard of care in the treatment of early-stage primary non-small cell lung cancers (NSCLCs) that are medically inoperable and for metastases in many anatomical locations. To date, local control and toxicity parameters with SABR for early-stage NSCLCs are comparable to those found in reports of experiences with surgical resection. It is increasingly apparent that some patients with borderline resectable lung primaries are also looking to SABR as a noninvasive means of therapy. However, randomized comparisons have not been completed to assess survival in operable patients. This review summarizes the advanced technology and radiation concepts that have helped clinicians optimize the use of stereotactic ablative therapies for lung cancer, with an emphasis on the rationale for future continued use of this advanced treatment modality.
An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. [2023]Stereotactic body radiotherapy (SBRT), also known as stereotactic ablative radiotherapy (SABR), is commonly used in inoperable patients with early-stage non-small lung cancer (NSCLC). This treatment has good outcomes and low toxicity in peripherally located tumors. However, in lesions which are located close to structures such as the bronchial tree or mediastinum the risk of severe toxicity increases. This review summarizes the evidence of dose-fractionation in SBRT of NSCLC patients in various locations.
Measuring the Integration of Stereotactic Ablative Radiotherapy Plus Surgery for Early-Stage Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial. [2022]Stereotactic ablative radiotherapy (SABR) is a standard treatment option in patients with medically inoperable early-stage non-small cell lung cancer (NSCLC), yet the pathologic complete response (pCR) rate after SABR is unknown. Neoadjuvant SABR in patients with cancer who are fit for resection has been hypothesized to improve local control and induce antitumor immune activity, potentially leading to better outcomes.
Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. [2023]Stereotactic ablative radiotherapy (SABR) is used for treating lung tumors but can cause toxic effects, including life-threatening damage to central structures. Retrospective data suggested that small tumors up to 10 cm3 in volume can be well controlled with a biologically effective dose less than 100 Gy.
Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. [2023]Stereotactic ablative radiation therapy (SABR) is the standard of care for inoperable early-stage non-small-cell lung cancer. Although the probability of grade ≥ II toxicities is low, many patients present radiological subclinical toxicities usually associated with long-term patient management challenges. We evaluated radiological changes and correlated them with the received Biological Equivalent Dose (BED).
A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). [2022]Stereotactic ablative body radiotherapy (SABR) is emerging as a non-invasive method for precision irradiation of lung tumours. However, the ideal dose/fractionation schedule is not yet known. The primary purpose of this study is to assess safety and efficacy profile of single and multi-fraction SABR in the context of pulmonary oligometastases.
Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]The clinical applications of stereotactic body radiotherapy or stereotactic ablative radiotherapy (SABR) for the treatment of primary and metastatic tumours of different organ sites have been expanding rapidly in the recent decade. SABR requires advanced technology in radiotherapy planning and image guidance to deliver a highly conformal ablative dose precisely to targets (or tumours) in the body. Although this treatment modality has shown promising results with regard to tumour control, some serious complications have been observed and reported. In order to achieve a favourable therapeutic ratio, strategies to mitigate the risk of complications must be in place. This overview will summarise the reported serious complications caused by SABR and strategies to mitigate the risk will be discussed.
Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. [2022]Stereotactic ablative body radiotherapy (SBRT, SABR) is being increasingly applied because of its high local efficacy, e.g., for small lung tumors. However, the optimum dosage is still under discussion. Here, we report data on 45 lung lesions [non-small cell lung cancer (NSCLC) or metastases] in 39 patients treated between 2009 and 2010 by SABR.
Stereotactic ablative radiotherapy in T1-2N0M0 small cell lung cancer: A systematic review and meta-analysis. [2022]Stereotactic ablative radiotherapy (SABR) is used to treat inoperable early-stage, node-negative small cell lung cancer (SCLC). We performed a systematic review and meta-analysis of the literature on SABR for T1-2N0M0 SCLC to summarize outcomes including local control (LC), overall survival (OS), recurrence rates, and toxicity.
Stereotactic body radiation therapy for treatment of primary and metastatic pulmonary malignancies. [2022]Stereotactic body radiation therapy (SBRT) has become the preferred treatment approach for patients with stage I non-small cell lung cancer who are medically inoperable or refuse surgery. SBRT consists of 3 to 5 radiation treatments delivered over a 10- to 14-day period. Local control is achieved in approximately 90% of patients, and the risk of toxicity is relatively low. Ongoing studies are examining whether SBRT can replace surgery for certain patients, the optimal dose-fractionation scheme, and how best to treat patients having central tumors near the primary tracheobronchial tree.