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Chemotherapy
Chemotherapy 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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the frequency and severity of adverse events
Progression Free Survival (PFS)
Secondary outcome measures
Objective Response Rate (ORR)
Side effects data
From 2014 Phase 4 trial • 45 Patients • NCT0200053129%
Nausea
19%
Leukopenia
14%
White blood cell count decreased
14%
Vomiting
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Anaemia
14%
Neutropenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Dizziness
5%
Back pain
5%
Diarrhea
5%
Musculoskeletal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib
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
4,287 Previous Clinical Trials
288,620,126 Total Patients Enrolled
Providence Cancer Center, Earle A. Chiles Research InstituteOTHER
18 Previous Clinical Trials
468 Total Patients Enrolled
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.
Lung Cancer Patient Testimony for trial: Trial Name: NCT04364048 — Phase 2
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