Combining systemic therapy with local ablative treatments for certain lung cancers

LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)

This study is testing if adding local treatments to ongoing therapy can help people with certain lung cancers live longer without their disease getting worse.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Davis (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Sacramento, California)
• Trial ID: NCT06103682 on ClinicalTrials.gov

What this trial studies

This phase 2 pragmatic study evaluates the clinical benefit of continuing systemic therapy while adding locally ablative therapies for patients with oligoprogressive solid tumors. The primary objective is to measure the time to treatment failure after the addition of ablative therapy. Participants will receive either stereotactic ablative radiotherapy or interventional radiology ablation therapy, depending on the treating physician's discretion. The study will follow participants for up to 5 years to assess disease control and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed non-small cell or small cell lung cancer who are currently on systemic therapy and have a limited number of new metastatic lesions.

Not a fit: Patients with extensive metastatic disease or those not currently receiving systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and prolong the effectiveness of systemic therapies for patients with oligoprogressive lung cancer.

How similar studies have performed: Other studies have shown promise in combining systemic and local therapies for cancer treatment, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:

   1. Cohort A: Non-small cell cancer
   2. Cohort B: Small cell cancer
2. Provision of signed and dated informed consent form.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Age ≥18 years at time of consent.
5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
7. ≤ 5 progressing or new metastatic lesions.
8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.

Exclusion Criteria:

1. Medical comorbidities precluding locally ablative therapies.
2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
3. Progressing intracranial lesions.

Where this trial is running

Sacramento, California

• University of California, Davis — Sacramento, California, United States (Recruiting)

Study contacts

• Principal investigator: Megan Daly, MD — University of California, Davis
• Study coordinator: Selina Laqui

Conditions Non-small Cell Lung Cancer; Oligoprogressive; Small-cell Lung Cancer