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Radiation Therapy + Durvalumab for Lung Cancer

Phase 1 & 2
Recruiting
Led By Chi Zhang, MD, PhD
Research Sponsored by Chi Zhang
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate normal organ and marrow function as defined below: Hemoglobin ≥9.0 g/dL (5.59 mmol/L) (patients can be transfused to meet this criterion), Absolute neutrophil count (ANC) > 1500 per mm3, Platelet count ≥100 x 109/L (>100,000 per mm3), Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN), AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal, Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula, 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, Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

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

Who is the study for?
Adults over 19 with stage III non-small cell lung cancer (NSCLC) who've had or are candidates for chemoradiation therapy. They must have good organ function, an ECOG performance status of 0-1, and a life expectancy over 12 weeks. Women must not be pregnant and participants should agree to birth control measures.Check my eligibility
What is being tested?
The trial tests if combining hypofractionated radiation therapy (hfRT) to target remaining lung cancer with Durvalumab, an anti-PD-L1 drug, is safe and improves tumor control better than either treatment alone.See study design
What are the potential side effects?
Potential side effects include immune system reactions that may affect organs, fatigue, skin conditions like rash or itching, digestive issues such as diarrhea or nausea, hormonal imbalances and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 20 years old or older.
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My lung cancer is at stage III and has been confirmed by a doctor.
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I am eligible for or have completed a specific cancer treatment involving chemotherapy and radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate progression free survival (PFS) when combining hfRT with adjuvant anti-PD-L1 therapy (durvalumab)
Evaluate the safety of combining hfRT and durvalumab by Adverse event assessed
Secondary outcome measures
Overall Survival hfRT and adjuvant anti-PD-L1 therapy
Progression Free survival (PFS) when combining hfRT with adjuvant anti-PD-L1 therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hypofractionated radiation therapy (hfRT) with DurvalumabExperimental Treatment2 Interventions
Combining consolidative radiation therapy (RT) using a hypofractionated regimen (hfRT) of 10Gy x 2 fractions for boosting the residual primary lung cancer with adjuvant anti-PD-L1 therapy (durvalumab), dose of 10 mg/kg infusion every two weeks concurrently for up to 12 months or disease progression.

Find a Location

Who is running the clinical trial?

Chi ZhangLead Sponsor
University of NebraskaLead Sponsor
535 Previous Clinical Trials
1,143,863 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,528,164 Total Patients Enrolled

Media Library

Consolidative Hypofractionated Radiation Therapy (hfRT) Clinical Trial Eligibility Overview. Trial Name: NCT04748419 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Hypofractionated radiation therapy (hfRT) with Durvalumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Consolidative Hypofractionated Radiation Therapy (hfRT) Highlights & Side Effects. Trial Name: NCT04748419 — Phase 1 & 2
Consolidative Hypofractionated Radiation Therapy (hfRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04748419 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current quota of participants for this medical trial?

"Affirmative. Clinicaltrials.gov divulges that this medical trial, which was initially posted on July 15th 2021, is actively enrolling patients. 43 participants are needed across 1 clinical site."

Answered by AI

Are there any common ailments which employ consolidative hypofractionated radiation therapy (hfRT) as a treatment?

"Consolidative hypofractionated radiation therapy (hfRT) is most commonly employed to treat stage III non-small cell lung cancer. It can also be used for cases such as metastatic ureter urothelial carcinoma and advanced directives when other treatments are not possible."

Answered by AI

Are there still openings in this investigation for participants?

"This clinical trial is actively recruiting as attested to on the clinicaltrials.gov website, having first been made available for public access in July 2021 and with its most recent update occurring November 2022."

Answered by AI

What other investigations have been completed concerning the effects of consolidative hypofractionated radiation therapy (hfRT)?

"At present, 333 clinical investigations are underway exploring the use of consolidative hypofractionated radiation therapy (hfRT), with 52 trials in Phase 3. Most studies based on this treatment can be found in Cordoba and Texas; however, there exist over 12 thousand other locations running hfRT trials."

Answered by AI
~18 spots leftby Mar 2026