Your session is about to expire
← Back to Search
Chemotherapy
Durvalumab + Chemoradiation for Lung Cancer
Phase 2
Waitlist Available
Led By Rachel Sanborn, MD
Research Sponsored by Rachel Sanborn
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer treatment that includes a drug called durvalumab, given before and after radiation therapy.
Who is the study for?
Adults over 18 with stage III non-small cell lung cancer eligible for chemoradiation, not previously treated for it. Must have an ECOG Performance Status of 0 or 1, no progression post-chemoradiation, and recovered from prior treatments' toxicities. No history of certain diseases or recent immunosuppressive meds; willing to use contraception if applicable.
What is being tested?
The trial tests Durvalumab given intravenously at the start (induction), before chemoradiation therapy, followed by additional cycles (consolidation) after chemoradiotherapy. The study includes a safety run-in phase to monitor patients closely before full enrollment.
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation in various organs, infusion reactions similar to allergic responses, fatigue, potential lung issues such as pneumonitis and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
12-Month Progression Free Survival (PFS)
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Secondary study objectives
Objective Response Rate (ORR)
Side effects data
From 2014 Phase 4 trial • 45 Patients • NCT0200053129%
Nausea
19%
Leukopenia
14%
Anaemia
14%
White blood cell count decreased
14%
Vomiting
14%
Neutropenia
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Dizziness
5%
Musculoskeletal pain
5%
Diarrhea
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Induction durvalumab, chemoradiation, consolidation durvalumabExperimental Treatment4 Interventions
Induction durvalumab at 1500 mg intravenously (IV) on Day 1 of a four week cycle for 1 cycle, followed by concurrent definitive chemoradiation, followed by consolidation durvalumab at 1500 mg IV Day 1 of every 4 week cycle for up to 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Radiation
2003
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Rachel SanbornLead Sponsor
AstraZenecaIndustry Sponsor
4,427 Previous Clinical Trials
289,164,442 Total Patients Enrolled
Providence Cancer Center, Earle A. Chiles Research InstituteOTHER
20 Previous Clinical Trials
493 Total Patients Enrolled
Rachel Sanborn, MD3.911 ReviewsPrincipal Investigator - Providence Cancer Institute
Hoosier Cancer Research Network
3 Previous Clinical Trials
119 Total Patients Enrolled
1Patient Review
My wife and I were both incredibly disappointed by Dr. Sanborn's behaviour. He was unprofessional and rude to my wife, and he didn't take the time to explain things to us. We had a terrible experience and my wife is too afraid of retribution to allow me to speak to RS about it.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Induction durvalumab, chemoradiation, consolidation durvalumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-Small Cell Carcinoma Patient Testimony for trial: Trial Name: NCT04364048 — Phase 2