NCT04992780RecruitingPhase 2
Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 7 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The hypothesis for this study is that hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with concurrent carboplatin and paclitaxel, followed by maintenance durvalumab will improve locoregional control at 18 months by 10% compared to standard-fractionated chemo-IMRT/durvalumab. A modest improvement in locoregional control (LRC) was selected as a target which could merit further study of this hypofractionated IMRT regimen in a Phase III trial
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 28 Jul 2021
- Start date
- 25 Feb 2022
- Primary completion date
- Oct 2025
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- Lung cancer
- NCT number
- NCT04992780
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 25 Feb 2022 to the primary completion date, Oct 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
- 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
Other illness
- 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
- 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
Other
- Is pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Kansas Cancer Center, North Clinic Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| The University of Kansas Cancer Center, Westwood Campus Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| The University of Kansas Cancer Center, Lee's Summit Clinic Coordinator of this site? Confirm its status | Lee's Summit | United States | Recruiting |
| University of Kansas Cancer Center, North Kansas City Hospital Coordinator of this site? Confirm its status | North Kansas City | United States | Recruiting |
| The University of Kansas Cancer Center, Overland Park Clinic Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| KUCC MCA- TUKHS, Saint Francis Hospital Coordinator of this site? Confirm its status | Topeka | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.