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Monoclonal Antibodies

Durvalumab + Chemoradiation for Non-Small Cell Lung Cancer

Phase 3
Waitlist Available
Led By Nathan A Pennell
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with nodal recurrence after surgery for early-stage NSCLC are eligible if specific criteria are met
Patients with any > grade 2 non-hematologic or > grade 3 hematologic toxicities must recover to grade 2 (or less) within 45 days after the end of Step 1 concurrent chemo/radiation, with the exception of alopecia and vitiligo
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years
Awards & highlights

Study Summary

This trial is testing whether adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.

Who is the study for?
Adults with stage IIIA/B/C non-small cell lung cancer that can't be surgically removed, or those with nodal recurrence after early-stage surgery. Participants must not have lost more than 10% of their weight unintentionally in the last month, should use effective contraception, and have no severe allergies to antibodies or history of certain infections.Check my eligibility
What is being tested?
The trial is testing if adding durvalumab (an antibody) to standard chemoradiation therapy and continuing it for a year improves outcomes compared to just chemoradiation followed by durvalumab. It's a phase III study aiming to see if this combination extends life or prevents cancer return.See study design
What are the potential side effects?
Durvalumab may cause immune-related reactions affecting organs, infusion-related symptoms, fatigue, possible harm to unborn babies (hence contraception requirement), and increased risk of infection due to its action on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My early-stage lung cancer returned in the lymph nodes after surgery.
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My side effects from previous cancer treatments have mostly improved within 45 days, except for hair loss or skin color changes.
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I have not lost more than 10% of my weight unintentionally in the last month.
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I have been diagnosed with stage IIIA/B/C non-small cell lung cancer that cannot be surgically removed.
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My cancer returned in the lymph nodes after early-stage lung cancer surgery.
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I have stage IIIA/B/C non-small cell lung cancer or it has come back in the nodes after surgery.
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I have not lost more than 10% of my weight unintentionally in the last month.
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I weigh more than 30 kilograms.
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I have another cancer, but it won't affect this trial's treatment.
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I am fully active or can carry out light work.
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I am HIV positive and meet all the study's requirements.
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I am 18 years old or older.
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I am using effective birth control methods as required.
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My lung function tests are within the required range.
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I have stage IIIA/B/C non-small cell lung cancer that cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 10 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
Overall survival (OS)
Secondary outcome measures
Best objective response
Incidence of adverse events
Local progression
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (durvalumab, chemotherapy, durvalumab)Experimental Treatment6 Interventions
STEP 1 (CONCURRENT THERAPY): Patients receive durvalumab IV over 60 minutes on days 1 and 15 of cycle 1 and day 1 of cycle 2. Patients also receive 1 of 3 treatment regimens per investigator choice: 1) etoposide IV over 60 minutes on days 1-5 and cisplatin IV over 60 minutes on days 1 and 8 every 28 days for 2 cycles; 2) pemetrexed disodium IV over 60 minutes and cisplatin IV over 60-120 minutes on day 1 every 21 days for 2 cycles; or 3) paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1 every 7 days for 6 cycles. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of chemotherapy, patients receive radiation therapy 5 days a week for 6 weeks. STEP 2 (CONSOLIDATION THERAPY): Within 14 days after the last dose of radiation (from Step 1), all patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (chemotherapy, durvalumab)Active Control6 Interventions
STEP 1 (CONCURRENT THERAPY): Patients receive 1 of 3 investigator's choice treatment regimens and radiation therapy as in Arm A. STEP 2 (CONSOLIDATION THERAPY): Within 14 days after the last dose of radiation (from Step 1), all patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Durvalumab
2017
Completed Phase 2
~3870
Etoposide
2010
Completed Phase 3
~2440
Paclitaxel
2011
Completed Phase 4
~5380
Pemetrexed Disodium
2015
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,493 Total Patients Enrolled
Nathan A PennellPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04092283 — Phase 3
Lung Cancer Research Study Groups: Arm A (durvalumab, chemotherapy, durvalumab), Arm B (chemotherapy, durvalumab)
Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04092283 — Phase 3
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04092283 — Phase 3

Frequently Asked Questions

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

Is there still room for volunteers in this research project?

"The trial is currently ongoing, according to the information provided on clinicaltrials.gov. This study was originally posted on April 9th, 2020, and the most recent update was on November 8th, 2020."

Answered by AI

Could you please summarize the evidence for Cisplatin's safety?

"Cisplatin's safety is based on both its efficacy in prior clinical trials and its multiple rounds of data supporting safety, giving it a score of 3."

Answered by AI

Is this study taking place at many different locations across America?

"There are 100 total sites for this study, which are located in Morgantown, Las Vegas, Elk Grove Village, and many other places. It would be most convenient for you to choose a location near you to minimize travel time and requirements."

Answered by AI

What is the primary function of Cisplatin?

"Metastatic ureter urothelial carcinoma is most commonly treated with Cisplatin. However, Cisplatin is also useful for treating other conditions, such as lymphoma, non-hodgkin, merkel cell cancer, and locally advanced non-small cell lung cancer."

Answered by AI

Could you tell us if Cisplatin has been used in other research projects?

"First researched in 1997, cisplatin has undergone 2799 completed clinical trials. As of now, 2047 trials are actively recruiting patients with a large portion of these taking place in Morgantown, West virginia."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Florida
California
Other
How old are they?
18 - 65
What site did they apply to?
Eden Hospital Medical Center
Palo Alto Medical Foundation-Sunnyvale
California Pacific Medical Center-Pacific Campus
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Alegent Health Mercy Hospital: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
2020. "Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04092283.
All > Alaska
~355 spots leftby Dec 2028
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