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NCT Number: NCT04992780

Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for 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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Kansas Cancer Center, Westwood Campus, Kansas City, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypo-Fractionation

Radiation

62.5 Gy in 25 fractions of 2.5 Gy/fraction

Standard-Fractionation

Radiation

60 Gy in 30 fractions of 2 Gy/fraction

Primary outcomes

  1. Locoregional control (LRC)

    Time frame: From enrollment for up to 7.5 years

    RECIST 1.1

Secondary outcomes

  1. Acute toxicities

    Time frame: From enrollment for up to 7.5 years

    CTCAE v. 5.0

  2. Late toxicities

    Time frame: From enrollment for up to 7.5 years

    CTCAE v. 5.0

  3. Progression free survival (PFS)

    Time frame: From enrollment for up to 7.5 years

    RECIST 1.1

  4. Overall survival (OS)

    Time frame: From enrollment for up to 7.5 years

    Kaplan-Meier

  5. Measuring the Impact of Treatment on the Quality of life (QOL)

    Time frame: From enrollment for up to 7.5 years

    EORTC Quality of Life Questionnaire (QLQ)-C30

  6. Measuring the Impact of Treatment on the Quality of life (QOL)

    Time frame: From enrollment for up to 7.5 years

    QLQ-Lung Cancer (LC)29

Study contacts

Contact information is provided by the study sponsor or research team.

KUCC Navigation

CONTACT

[email protected]

913-588-3671

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2021
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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