Non Small Cell Lung Cancer StagePhase 2NCT04992780
Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
A Phase 2 study testing Hypo-Fractionation and Standard-Fractionation in people with Non Small Cell Lung Cancer Stage, run by University of Kansas Medical Center at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer Stage
- What is being tested?
- Hypo-Fractionation and Standard-Fractionation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Feb 2022to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu
- Recruiting
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, 64154
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Recruiting
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, 64064
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Recruiting
University of Kansas Cancer Center, North Kansas City Hospital
North Kansas City, Missouri, 64116
Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Recruiting
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, 66210
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Not yet recruiting
KUCC MCA- TUKHS, Saint Francis Hospital
Topeka, Kansas, 66606
KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu
About this study
Official title: 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
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
- Conditions
- Non Small Cell Lung Cancer Stage
- Being tested
- Hypo-Fractionation, Standard-Fractionation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypo-FractionationRadiation
62.5 Gy in 25 fractions of 2.5 Gy/fraction
Standard-FractionationRadiation
60 Gy in 30 fractions of 2 Gy/fraction
| Study group | Role | What they receive |
|---|---|---|
| Hypo-Fractionation | Experimental | Participants will receive one fraction of radiation therapy a day for 5 days each week for 5 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin area under the curve (AUC) 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months. Receives: Radiation: Hypo-Fractionation |
| Standard-Fractionation | Active comparator | Participants will receive one fraction of radiation therapy a day for 5 days each week for 6 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin AUC 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months. Receives: Radiation: Standard-Fractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control (LRC)
RECIST 1.1
Measured: From enrollment for up to 7.5 years
Secondary outcomes (6)
Acute toxicities
CTCAE v. 5.0
Measured: From enrollment for up to 7.5 years
Late toxicities
CTCAE v. 5.0
Measured: From enrollment for up to 7.5 years
Progression free survival (PFS)
RECIST 1.1
Measured: From enrollment for up to 7.5 years
Overall survival (OS)
Kaplan-Meier
Measured: From enrollment for up to 7.5 years
Measuring the Impact of Treatment on the Quality of life (QOL)
EORTC Quality of Life Questionnaire (QLQ)-C30
Measured: From enrollment for up to 7.5 years
Measuring the Impact of Treatment on the Quality of life (QOL)
QLQ-Lung Cancer (LC)29
Measured: From enrollment for up to 7.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start25 Feb 2022
- Primary completionOct 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer StageStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krishna Reddy, MD, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992780
- Sponsor's protocol ID
- IIT-2021-LU-HypoIMRT
- Status last verified
- Dec 2023
- First submitted
- 28 Jul 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04992780
- Acronym / sponsor ID
- IIT-2021-LU-HypoIMRT
- Conditions
- Non Small Cell Lung Cancer Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypo-Fractionation | Experimental | Radiation: Hypo-FractionationParticipants will receive one fraction of radiation therapy a day for 5 days each week for 5 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin area under the curve (AUC) 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months. |
| Standard-Fractionation | Active comparator | Radiation: Standard-FractionationParticipants will receive one fraction of radiation therapy a day for 5 days each week for 6 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin AUC 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypo-Fractionation62.5 Gy in 25 fractions of 2.5 Gy/fraction | Radiation | Hypo-Fractionation |
| Standard-Fractionation60 Gy in 30 fractions of 2 Gy/fraction | Radiation | Standard-Fractionation |
Primary outcome
Locoregional control (LRC)
Time frame: From enrollment for up to 7.5 years
RECIST 1.1
6 secondary outcomes
Acute toxicities
Time frame: From enrollment for up to 7.5 years
Late toxicities
Time frame: From enrollment for up to 7.5 years
Progression free survival (PFS)
Time frame: From enrollment for up to 7.5 years
Overall survival (OS)
Time frame: From enrollment for up to 7.5 years
Measuring the Impact of Treatment on the Quality of life (QOL)
Time frame: From enrollment for up to 7.5 years
Measuring the Impact of Treatment on the Quality of life (QOL)
Time frame: From enrollment for up to 7.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krishna Reddy, MD, PhD principal investigator
University of Kansas Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypo-Fractionation and Standard-Fractionation in people with Non Small Cell Lung Cancer Stage, run by University of Kansas Medical Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KUCC Navigation (913-588-3671, kucc_navigation@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control (LRC) (time frame: From enrollment for up to 7.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.