Safety & Efficacy of Consolidative Hypofractionated Radiation Therapy for Boosting Residual Lung … (NCT04748419) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety & Efficacy of Consolidative Hypofractionated Radiation Therapy for Boosting Residual Lung Cancer With Durvalumab
United States6 participantsStarted 2021-07-15
Plain-language summary
This study is designed to determine if combining consolidative radiation therapy (RT) using a hypofractionated regimen (hfRT) (2 fractions) for boosting the residual primary lung cancer with adjuvant anti-PD-L1 therapy concurrently is safe and will provide better tumor control locoregionally and distantly than either modality alone.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Pathologically diagnosed NSCLC (squamous cell carcinoma, adenocarcinoma, large- cell carcinoma, or non-small-cell lung cancer not otherwise specified), clinical stage III (AJCC 8th Ed.))
✓. At time of consent, potential subjects must be a candidate for dCRT OR Must have received dCRT with at least 2 cycles of platinum-based chemotherapy concurrent with conventional fractionated radiation therapy with a total dose of 5700 - 6300 cGy
✓. Patients must be aware of the nature of his/her disease and willingly provide written, informed consent. Including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
✓. Age \> 19 years at time of study entry
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at time of enrollment.
✓. Life expectancy of \> 12 weeks
✓. Adequate normal organ and marrow function as defined below:
✓. Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
Exclusion criteria
✕. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
What they're measuring
1
Evaluate the safety of combining hfRT and durvalumab by Adverse event assessed
Timeframe: 2 years
2
Evaluate progression free survival (PFS) when combining hfRT with adjuvant anti-PD-L1 therapy (durvalumab)
✕. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4
✕. Participation in another clinical study with an investigational product during the last 4 weeks
✕. Concurrent enrolment in another clinical study, unless it is an observational (non- interventional) clinical study or during the follow-up period of an interventional study
✕. Mixed small cell and non-small cell lung cancer histology
✕. Patients who receive sequential chemoradiation therapy for locally advanced NSCLC
✕. Patients with locally advanced NSCLC who have progressed during definitive platinum based, concurrent chemoradiation therapy
✕. Any unresolved toxicity NCI CTCAE Grade \>2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria