What is the mechanism of action of this treatment?

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include locally ablative therapies, chemotherapy, targeted therapy, and immunotherapy. Locally ablative therapies, such as stereotactic body radiation therapy (SBRT) and radiofrequency ablation (RFA), work by directly destroying tumor cells at specific sites, which can help control localized disease and potentially prolong survival. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while targeted therapies inhibit specific molecular pathways essential for tumor growth and survival. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. These treatments are crucial for NSCLC patients as they offer multiple strategies to manage the disease, improve survival rates, and maintain quality of life.

What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) that involve locally ablative therapies, such as stereotactic body radiation therapy (SBRT) and surgical resection, have specific side effects. SBRT is generally well-tolerated but can cause mild to moderate side effects such as fatigue, skin irritation, and cough. More severe side effects, though less common, include radiation pneumonitis and rib fractures. Surgical resection can lead to complications such as pain, infection, and reduced lung function. Both treatments aim to control the disease locally with a relatively favorable toxicity profile.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC) that involve direct tumor cell destruction or complement such approaches. Stereotactic body radiation therapy (SBRT) and other forms of radiotherapy are commonly used locally ablative therapies. Additionally, systemic therapies such as immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab) and targeted therapies (e.g., tyrosine kinase inhibitors like osimertinib for EGFR mutations) have been approved and are often used in conjunction with local treatments to enhance efficacy. These therapies aim to control both primary and metastatic sites of NSCLC, improving overall survival and progression-free survival in patients.

What other types of research exist?

Promising novel alternatives to Locally Ablative Therapies for NSCLC patients include: 1) Combined modality therapy, which integrates systemic treatments with local therapies to enhance effectiveness and reduce toxicity. 2) Immune checkpoint inhibitors, such as anti-PD-1 or anti-PD-L1 therapies, which have shown efficacy in improving survival rates. 3) Advanced chemotherapeutic compounds that are more active and have fewer side effects. 4) Early detection and prevention strategies based on genetic mutation knowledge and pharmacologic approaches to overcome them. These alternatives are supported by ongoing clinical trials and emerging evidence in the field.

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Procedure

Ablative Therapy for Lung Cancer (OBLITERATE Trial)

N/A

Recruiting

Led By Megan Daly, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

Age ≥18 years at time of consent

Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies: Cohort A: Non-small cell cancer, Cohort B: Small cell cancer

Must not have

History of treatment related toxicities that limit or prohibit application of locally ablative therapies

Progressing intracranial lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months from the first day of ablative local therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if adding specific treatments to current cancer medications helps patients with a few growing cancer spots. The goal is to see if this combined approach can better control the cancer by treating the whole body and directly attacking specific areas.

Who is the study for?

This trial is for adults over 18 with certain lung cancers (non-small or small cell) who've seen benefits from their current cancer treatment but have a few new or worsening spots of cancer. They must be able to undergo local therapies like radiation and continue their systemic therapy with a short break.

What is being tested?

The study tests if adding local treatments, such as targeted radiation, to ongoing systemic therapy helps control cancer when only a few areas are getting worse. The main goal is to see how long patients can stay on their current treatment without needing to change it due to the cancer progressing.

What are the potential side effects?

While specific side effects aren't listed here, locally ablative therapies like radiation may cause skin irritation, fatigue, mild pain at the treatment site, and sometimes more serious issues depending on the area treated.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have a confirmed diagnosis of either non-small cell or small cell genitourinary cancer.

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I have 5 or fewer new or worsening cancer spots.

Exclusion Criteria

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

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I have side effects from past treatments that prevent me from undergoing certain cancer therapies.

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My brain tumor is growing.

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I have health conditions that prevent me from undergoing targeted cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months from the first day of ablative local therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months from the first day of ablative local therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months from the first day of ablative local therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with controlled disease

Secondary study objectives

Median overall survival

Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy

Time to treatment failure

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ablative local therapyExperimental Treatment1 Intervention

Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include locally ablative therapies, chemotherapy, targeted therapy, and immunotherapy. Locally ablative therapies, such as stereotactic body radiation therapy (SBRT) and radiofrequency ablation (RFA), work by directly destroying tumor cells at specific sites, which can help control localized disease and potentially prolong survival. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while targeted therapies inhibit specific molecular pathways essential for tumor growth and survival. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. These treatments are crucial for NSCLC patients as they offer multiple strategies to manage the disease, improve survival rates, and maintain quality of life.

Optimize Local Therapy for Oligometastatic and Oligoprogressive Non-Small Cell Lung Cancer to Enhance Survival.