consolidative hypofractionated radiation therapy (hfRT) for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Small Cell Lung Cancer+1 Moreconsolidative hypofractionated radiation therapy (hfRT) - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if adding a second cancer-fighting treatment to radiation therapy will improve outcomes for people with lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Lung Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 2 years

12 months
Overall Survival when combining hfRT with adjuvant anti-PD-L1 therapy
12-month
Evaluate progression free survival (PFS) when combining hfRT with adjuvant anti-PD-L1 therapy (durvalumab)
18 months
Progression Free survival (PFS) when combining hfRT with adjuvant anti-PD-L1 therapy
2 years
Evaluate the safety of combining hfRT and durvalumab by Adverse event assessed

Trial Safety

Trial Design

1 Treatment Group

Hypofractionated radiation therapy (hfRT) with Durvalumab
1 of 1

Experimental Treatment

43 Total Participants · 1 Treatment Group

Primary Treatment: consolidative hypofractionated radiation therapy (hfRT) · No Placebo Group · Phase 1 & 2

Hypofractionated radiation therapy (hfRT) with DurvalumabExperimental Group · 2 Interventions: consolidative hypofractionated radiation therapy (hfRT), Durvalumab 50 MG/ML · Intervention Types: Radiation, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Chi ZhangLead Sponsor
AstraZenecaIndustry Sponsor
3,996 Previous Clinical Trials
247,423,582 Total Patients Enrolled
Chi Zhang, MD, PhDPrincipal Investigator - University of Nebraska
University of Nebraska

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.
You have a hemoglobin level of 9.0 g/dL (5.59 mmol/L) or higher.
You must be at least 19 years old at the time of study entry.
You have a life expectancy of at least 12 weeks.
Platelet count ≥100 x 109/L (>100,000 per mm3).
You have serum bilirubin ≤1.5 x ULN.