Clinical Trials /

Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer

NCT04992780

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: IIT-2021-LU-HypoIMRT
  • NCT ID: NCT04992780

Conditions

  • Non Small Cell Lung Cancer Stage

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Hypo-FractionationExperimentalParticipants 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-FractionationActive ComparatorParticipants 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.

      Eligibility 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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Locoregional control (LRC)
      Time Frame:From enrollment for up to 7.5 years
      Safety Issue:
      Description:RECIST 1.1

      Secondary Outcome Measures

      Measure:Acute toxicities
      Time Frame:From enrollment for up to 7.5 years
      Safety Issue:
      Description:CTCAE v. 5.0
      Measure:Late toxicities
      Time Frame:From enrollment for up to 7.5 years
      Safety Issue:
      Description:CTCAE v. 5.0
      Measure:Progression free survival (PFS)
      Time Frame:From enrollment for up to 7.5 years
      Safety Issue:
      Description:RECIST 1.1
      Measure:Overall survival (OS)
      Time Frame:From enrollment for up to 7.5 years
      Safety Issue:
      Description:Kaplan-Meier
      Measure:Measuring the Impact of Treatment on the Quality of life (QOL)
      Time Frame:From enrollment for up to 7.5 years
      Safety Issue:
      Description:EORTC Quality of Life Questionnaire (QLQ)-C30
      Measure:Measuring the Impact of Treatment on the Quality of life (QOL)
      Time Frame:From enrollment for up to 7.5 years
      Safety Issue:
      Description:QLQ-Lung Cancer (LC)29

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:University of Kansas Medical Center

      Last Updated

      August 12, 2021