Using targeted radiotherapy and chemotherapy for advanced lung cancer with limited metastases

SBRT/RT to All Sites of Disease After Three Months of First-line Systemic Chemotherapy in Oligometastatic Stage IV NSCLC Before Maintenance

This study tests if combining targeted radiotherapy with ongoing chemotherapy can help people with advanced lung cancer that has spread to a few places live longer without their cancer getting worse.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University Hospital Ostrava (other)
• Drugs / interventions: erlotinib, gefitinib, crizotinib, chemotherapy
• Locations: 1 site (Ostrava, Moravian-Silesian Region)
• Trial ID: NCT05647590 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of consolidative Stereotactic Body Radiotherapy (SBRT) followed by maintenance chemotherapy in patients with non-small cell lung cancer (NSCLC) that has spread to a maximum of 10 metastatic sites. The aim is to improve progression-free survival compared to maintenance chemotherapy alone. Patients will undergo SBRT using the CyberKnife system, which allows for precise targeting of tumors while minimizing damage to surrounding tissues. The study focuses on patients who have shown stable disease or partial response after initial chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven metastatic NSCLC who have stable disease or partial response after three months of first-line chemotherapy.

Not a fit: Patients with extensive metastatic disease beyond 10 sites or those who have not responded to initial chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the duration of disease control for patients with advanced NSCLC and limited metastases.

How similar studies have performed: Previous studies have shown promising results with SBRT in similar patient populations, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Patients must have biopsy-proven metastatic NSCLC (Stage IV).
* Patients must have received three months of first-line chemotherapy and achieved stable disease or partial response.
* Age ≥ 18 years
* Patients must have measurable disease at baseline.
* Patients can have up to 10 discrete active extracranial/intracranial lesions identified by PET/CT or MRI scan within 8 weeks prior to the initiation of SBRT.
* Patients must have a Karnofsky Performance Scale (KPS) \>60
* AST, ALT \& Alkaline phosphates must be ≤ 2.5x the upper limit of normal. Total bilirubin must be within the limit of normal.
* Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
* Patients should have adequate renal function (serum creatinine ≤1.5 times the upper limit of normal (ULN).
* Females of childbearing potential should have a negative pregnancy test.
* Patients who would be receiving SBRT for lung tumors must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
* Patients must provide verbal and written informed consent to participate in the study

Exclusion Criteria:

* Patients receiving first-line erlotinib, gefitinib, or crizotinib for EGFR mutant-positive or EML4-ALK-positive NSCLC will be excluded.
* Patients who previously received radiotherapy at the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy
* Patients with serious, uncontrolled, concurrent infection(s)
* Significant weight loss (\>10%) in the prior 3 months
* Patients with cutaneous metastasis of NSCLC
* Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers
* Patients with more than 10 discrete extra/intracranial lesions
* Participation in any investigational drug study within 4 weeks preceding the start of study treatment
* Unwillingness to participate or inability to comply with the protocol for the duration of the study
* Patients who are pregnant; patients with reproductive capability will need to use adequate contraception during the time of participation in the study

Where this trial is running

Ostrava, Moravian-Silesian Region

• University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (RECRUITING)

Study contacts

• Principal investigator: Tereza Paračková, MD — University Hospital Ostrava
• Study coordinator: Jiří Hynčica

Conditions: Non Small Cell Lung Cancer, non small cell lung cancer, radiotherapy, stereotactic robotic radiotherapy, chemotherapy, CyberKnife, acceptable toxicity