Ablative Therapy for Lung Cancer

(OBLITERATE Trial)

Overseen By Selina Laqui, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must be taking: Systemic therapy

Disqualifiers: Medical comorbidities, Intracranial lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not require you to stop your current medications. You can continue your current systemic therapy, with a possible break of up to 30 days for the local ablative therapy.

What data supports the effectiveness of the treatment Locally Ablative Therapy for lung cancer?

Research shows that local ablative therapy, which includes treatments like surgery and radiotherapy, can improve outcomes for patients with certain types of lung cancer, such as oligometastatic non-small cell lung cancer. Studies have found that these treatments can help prolong the time patients live without the disease getting worse and may also increase overall survival. ^{1 2 3 4 5}

Is ablative therapy for lung cancer safe for humans?

Ablative therapy for lung cancer, including techniques like radiofrequency ablation and cryoablation, is generally considered safe for humans, especially for those who cannot undergo surgery. Common side effects include pneumothorax (collapsed lung), pleural inflammation, and pneumonia, but these are usually manageable. ^{1 4 6 7 8}

How is locally ablative therapy different from other treatments for lung cancer?

Locally ablative therapy for lung cancer is unique because it involves directly targeting the tumor with heat, cold, or electrical fields to destroy cancer cells, offering a minimally invasive option for patients who cannot undergo surgery. This approach is particularly beneficial for those with tumors in difficult-to-reach areas or who have a high surgical risk, providing an alternative to traditional surgery, radiotherapy, and chemotherapy. ^{1 8 9 10 11}

Research Team

Megan E. Daly

Principal Investigator

University of California, Davis

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I am willing and able to follow the study rules and attend all appointments.

I've had at least one treatment for my cancer that spread, and it worked for 3 months before the cancer grew.

Exclusion Criteria

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

My brain tumor is growing.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ablative Local Therapy

Participants receive stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

3 months

Visits as per standard practices

Follow-up

Participants are monitored for disease control and adverse events

5 years

Treatment Details

Interventions

• Locally Ablative Therapy

Trial Overview 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.

Participant Groups

Group I: Ablative local therapy Experimental Treatment 1 Intervention

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

Locally Ablative Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Locally Ablative Therapy for:

• Liver cancer
• Colorectal carcinoma metastases
• Hepatocellular carcinoma
• Neuroendocrine malignancies

Approved in United States as Locally Ablative Therapy for:

• Primary liver cancer
• Metastatic liver cancer
• Hepatocellular carcinoma
• Colorectal carcinoma metastases

Approved in Canada as Locally Ablative Therapy for:

• Liver cancer
• Hepatocellular carcinoma
• Colorectal carcinoma metastases

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 176 patients with oligometastatic lung adenocarcinoma, local ablative radiotherapy (LART) significantly improved progression-free survival (PFS), especially in patients treated with tyrosine kinase inhibitors (TKIs) and those receiving LART at all metastatic sites, with a 1-year PFS of 86.7%.

LART also showed potential in extending survival for patients with repeat oligoprogression by delaying changes in systemic therapy, indicating its role as an effective treatment option in managing oligometastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggressive Local Ablative Radiotherapy Mitigates Progression Risk in Oligometastatic Lung Adenocarcinoma. Yang, G., Kim, KH., Lee, CG., et al.[2023]

Local ablative treatment (LAT) significantly improves overall survival (OS) and progression-free survival (PFS) in patients with oligometastatic nonsmall cell lung cancer, with pooled odds ratios showing a 3.49 times higher chance of OS and 3.74 times higher chance of PFS compared to standard care across 20 studies involving 1750 patients.

Sensitivity analyses, including randomized controlled trials, further support LAT's efficacy, showing even greater odds ratios of 4.11 for OS and 4.96 for PFS, indicating that LAT is a beneficial treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of local ablative treatment in oligometastatic non-small cell lung cancer: a meta-analysis. Rim, CH., Cho, WK., Park, S., et al.[2023]

Transbronchial therapies, particularly microwave ablation, are becoming increasingly important for treating multifocal lung cancers and patients who cannot undergo surgery, reflecting a shift towards more localized and less invasive treatment options.

Innovative adjunct technologies, such as mobile C-arm platforms and robotic bronchoscopy, are enhancing the efficiency and accuracy of transbronchial ablation, which may lead to better outcomes in lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transbronchial Techniques for Lung Cancer Treatment: Where Are We Now? Chan, JWY., Siu, ICH., Chang, ATC., et al.[2023]

Aggressive treatment approaches, including local ablative therapy (LAT) such as radiation and surgery, have shown efficacy and safety in prolonging disease-free and overall survival in select patients with oligometastatic non-small cell lung cancer (NSCLC).

Despite promising results from recent randomized trials, there is still a need for more robust clinical evidence and validated biomarkers to guide treatment decisions for patients with oligometastatic NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Ablative Therapy in Oligometastatic NSCLC. Li, X., Gomez, D., Iyengar, P.[2022]

Local ablative therapy, such as surgery, stereotactic radiotherapy, and radiofrequency ablation, has been shown to improve outcomes for patients with oligometastatic and oligoprogressive non-small cell lung cancer (NSCLC).

Historically, treatment for metastatic NSCLC was mainly palliative, but recent evidence over the past 30 years suggests that targeted local treatments can lead to better survival rates and overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Ablative Therapies for Oligometastatic and Oligoprogressive Non-Small Cell Lung Cancer. Jairam, V., Park, HS., Decker, RH.[2021]

Lung cancer is the leading cause of death in adults, and while surgical resection is the preferred treatment, many patients cannot undergo surgery due to health issues or limited lung function.

Image ablation techniques, specifically radiofrequency ablation and cryoablation, offer safe alternative treatments for localized lung cancer in selected patients, providing options for those who are not surgical candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How I do it: radiofrequency ablation and cryoablation of lung tumors. Sharma, A., Moore, WH., Lanuti, M., et al.[2011]

Image-guided ablative therapies, particularly radiofrequency ablation, are safe and effective for controlling localized lung tumors in patients who cannot undergo surgery due to the extent of their disease or other health issues.

These therapies can slow disease progression and extend disease-free survival, with manageable complications such as pneumothorax and pneumonia, making them a valuable option in lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided percutaneous ablation of lung malignancies: A minimally invasive alternative for nonsurgical patients or unresectable tumors. Chamarthy, MR., Gupta, M., Hughes, TW., et al.[2014]

Lobar resection remains the standard treatment for early-stage non-small cell lung cancer (NSCLC), but sublobar resection (SLR) is being compared as a less invasive alternative for patients with T1N0 NSCLC.

For patients who cannot undergo surgery, options like stereotactic body radiotherapy (SBRT) and various ablation techniques are available, with ongoing research into bronchoscopic methods that leverage existing percutaneous techniques for effective tumor treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Bronchoscopy for Lung Nodules: Where Are We Now? Folch, E., Guo, Y., Senitko, M.[2022]

Irreversible electroporation is a promising new ablation technique for treating localized non-small cell lung carcinoma (NSCLC), especially in challenging tumor locations where traditional methods may be less effective.

The review discusses various established and novel ablation methods, highlighting their mechanisms, indications, potential complications, and clinical outcomes, which can guide treatment decisions for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal ablation of stage I non-small cell lung carcinoma. Ridge, CA., Solomon, SB., Thornton, RH.[2021]

About 80% of lung cancers are not operable, leading to a need for alternative treatments like local ablation therapy, which offers a promising option for patients with unresectable tumors.

Guidelines have been developed by a multidisciplinary team to standardize thermal ablation procedures, ensuring proper candidate selection, outcome assessment, and complication prevention, which enhances the safety and efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors (2018 edition). Ye, X., Fan, W., Wang, H., et al.[2018]

Percutaneous ablation is an effective non-invasive technique for treating metastatic lung tumors, particularly in patients with slowly evolving disease, allowing for multiple local treatments with minimal impact on lung function.

This method has low morbidity and is generally safe, although its effectiveness can be limited by the size and location of the tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Is there a curative treatment for oligometastases? Lung radiofrequency ablation]. Palussière, J., Descat, E., Cornélis, F.[2012]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Aggressive Local Ablative Radiotherapy Mitigates Progression Risk in Oligometastatic Lung Adenocarcinoma. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Role of local ablative treatment in oligometastatic non-small cell lung cancer: a meta-analysis. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transbronchial Techniques for Lung Cancer Treatment: Where Are We Now? [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Local Ablative Therapy in Oligometastatic NSCLC. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Local Ablative Therapies for Oligometastatic and Oligoprogressive Non-Small Cell Lung Cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

How I do it: radiofrequency ablation and cryoablation of lung tumors. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

Image-guided percutaneous ablation of lung malignancies: A minimally invasive alternative for nonsurgical patients or unresectable tumors. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Therapeutic Bronchoscopy for Lung Nodules: Where Are We Now? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Thermal ablation of stage I non-small cell lung carcinoma. [2021]

10. India pubmed.ncbi.nlm.nih.gov

Expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors (2018 edition). [2018]

11. France pubmed.ncbi.nlm.nih.gov

[Is there a curative treatment for oligometastases? Lung radiofrequency ablation]. [2012]