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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 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 • NCT02000531
29%
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 3
~1020

Find a Location

Who is running the clinical trial?

Rachel SanbornLead Sponsor
AstraZenecaIndustry Sponsor
4,267 Previous Clinical Trials
288,611,971 Total Patients Enrolled
Providence Cancer Center, Earle A. Chiles Research InstituteOTHER
18 Previous Clinical Trials
468 Total Patients Enrolled

Media Library

Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04364048 — Phase 2
Lung Cancer Research Study Groups: Induction durvalumab, chemoradiation, consolidation durvalumab
Lung Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT04364048 — Phase 2
Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04364048 — Phase 2
Lung Cancer Patient Testimony for trial: Trial Name: NCT04364048 — Phase 2

Frequently Asked Questions

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

What are some of the side effects that come with Chemotherapy?

"Chemotherapy is still being tested for efficacy in Phase 2 trials, but there is enough evidence of safety to give it a score of 2."

Answered by AI

What is the patient population for this research?

"In order to carry out the study, 54 patients that meet the criteria will need to be recruited. The trial is set to be conducted by AstraZeneca from multiple locations, such as HealthPartners Institute in Minneapolis, Minnesota and Cancer Center of Kansas in Wichita, Kansas."

Answered by AI

Are we still receiving applications for this clinical trial?

"That is correct, the online information specifies that the trial is currently looking for test subjects. The posting went up on 6/18/2020 and was last edited 7/18/2022. They are trying to find 54 individuals total from 5 different locations."

Answered by AI

Are there any other similar drugs to this one in terms of treatment?

"City of Hope Comprehensive Cancer Center first began studying chemotherapy in 1997 and, to date, there have been 2250 completed clinical trials. At the moment, there are 1615 live trials underway with many of these studies based out of Minneapolis, Minnesota."

Answered by AI

Could you tell me how many different test facilities are currently conducting this research?

"The primary locations for this study are at HealthPartners Institute in Minneapolis, Minnesota, Cancer Center of Kansas in Wichita, Kansas, and Rush University Medical Center in Chicago, Illinois. There are 5 additional research sites."

Answered by AI

What are some of the most common reasons why a doctor might recommend Chemotherapy?

"Chemotherapy is often used as an initial treatment for a variety of cancers, including prostate cancer, small cell lung cancer (sclc), and advanced testicular cancer."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

i've tried many times but failed.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Durvalumab Followed by Chemoradiation and Consolidation Durvalumab for Stage III Non-small Cell Lung Cancer
Rachel Sanborn 2020. "Durvalumab Followed by Chemoradiation and Consolidation Durvalumab for Stage III Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04364048.
All > Lung Cancer Chicago
~2 spots leftby Apr 2025
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