Comparing two radiation therapy methods for lung cancer treatment
A Randomized Phase II Trial of Hypo-fractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction Versus (VS) Standard-Fractionated IMRT, Concurrent With Carboplatin/Paclitaxel and Followed by Consolidation Durvalumab, for Subjects With Stage 2A/B Non-Small Cell Lung Cancer
This study is testing whether a new type of radiation therapy combined with chemotherapy and immunotherapy can help people with advanced non-small cell lung cancer do better than the standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | durvalumab |
| Locations | 6 sites (Kansas City, Kansas and 5 other locations) |
| Trial ID | NCT04992780 on ClinicalTrials.gov |
What this trial studies
This study aims to compare hypofractionated intensity-modulated radiation therapy (IMRT) with standard-fractionated IMRT, both combined with chemotherapy and immunotherapy, for patients with non-small cell lung cancer (NSCLC) at stages IIIA or IIIB. The hypothesis is that the hypofractionated approach will improve locoregional control at 18 months by 10% compared to the standard method. Participants will receive either treatment regimen and will be monitored for disease progression and response to therapy. The study is designed as a Phase 2 interventional trial to assess the efficacy of the new treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed Stage IIIA or IIIB non-small cell lung cancer and no evidence of metastatic disease.
Not a fit: Patients with metastatic non-small cell lung cancer or those with an ECOG performance status greater than 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced non-small cell lung cancer.
How similar studies have performed: Other studies have shown promising results with hypofractionated radiation therapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent * Males and females age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2 * Measurable disease by RECIST 1.1 * Women of childbearing potential must have a negative serum pregnancy test within one month prior to initiating treatment * Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC) * No Positron Emission Tomography (PET)/CT evidence of metastatic disease * An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons * If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible * Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 90 days following completion of therapy * Adequate organ function per laboratory results Exclusion Criteria: * Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study * Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements * Evidence of severe or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator * Is pregnant or breastfeeding * Active connective tissue disorders, such as active lupus or scleroderma * Known Acquired Immune Deficiency (HIV (+)/AIDS) * Has a known allergic reaction to any excipient contained in the study drug formulations * Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment * Prior thoracic radiotherapy
Where this trial is running
Kansas City, Kansas and 5 other locations
- The University of Kansas Cancer Center, Westwood Campus — Kansas City, Kansas, United States (Recruiting)
- The University of Kansas Cancer Center, Overland Park Clinic — Overland Park, Kansas, United States (Recruiting)
- KUCC MCA- TUKHS, Saint Francis Hospital — Topeka, Kansas, United States (Not_yet_recruiting)
- The University of Kansas Cancer Center, North Clinic — Kansas City, Missouri, United States (Recruiting)
- The University of Kansas Cancer Center, Lee's Summit Clinic — Lee's Summit, Missouri, United States (Recruiting)
- University of Kansas Cancer Center, North Kansas City Hospital — North Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Krishna Reddy, MD, PhD — University of Kansas Medical Center
- Study coordinator: KUCC Navigation
- Email: kucc_navigation@kumc.edu
- Phone: 913-588-3671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.