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Checkpoint Inhibitor

Chemotherapy + Durvalumab for Lung Cancer

Phase 2
Waitlist Available
Led By Evanthia Galanis, MD
Research Sponsored by Alliance Foundation Trials, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Operability is defined as having adequate pulmonary, cardiac, renal, nutritional, musculoskeletal, neurologic, and cognitive capacity to undergo major pulmonary resection with acceptable morbidity and mortality
Organ and marrow function within specified limits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat NSCLC. The goal is to increase the N2 nodal clearance (N2NC) to 50% or greater.

Who is the study for?
Adults with stage IIIA/B Non-Small Cell Lung Cancer that can be removed by surgery. They must have good overall health, no prior lung cancer treatments or thoracic radiation, and not have certain autoimmune diseases or a history of other cancers within the last 2 years. Women who can bear children and men must agree to use contraception.Check my eligibility
What is being tested?
The trial tests if adding Durvalumab (an immune checkpoint inhibitor) to standard chemotherapy before and after surgery can improve outcomes for patients with operable lung cancer. It aims to clear cancer from lymph nodes better than chemotherapy alone.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation in various organs, infusion reactions, fatigue, possible worsening of pre-existing autoimmune conditions, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am healthy enough for major lung surgery.
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My organ and bone marrow functions are within normal ranges.
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I agree to use birth control during and for 12 weeks after the study.
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My N2 lymph nodes are separate from surrounding tissues and smaller than 3 cm.
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I am using two birth control methods or am not having sex to join this study.
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I am fully active or can carry out light work.
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I have seen a lung surgeon within the last month.
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I have had a biopsy of the lymph nodes in my chest before surgery.
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I have never had radiation therapy to my chest.
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I am 18 years old or older.
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I can make my own medical decisions or have someone who can.
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My cancer was confirmed to be in the lymph nodes within the last month.
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My lung cancer is at a stage where surgery could remove it completely.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
N2 nodal clearance (N2NC)
Secondary outcome measures
Evaluate event free survival (EFS)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall survival rate
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment3 Interventions
Combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610
Durvalumab
2017
Completed Phase 2
~3870
Surgery
2000
Completed Phase 3
~2550

Find a Location

Who is running the clinical trial?

Alliance Foundation Trials, LLC.Lead Sponsor
23 Previous Clinical Trials
24,994 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,238 Previous Clinical Trials
288,471,383 Total Patients Enrolled
Evanthia Galanis, MDPrincipal InvestigatorAlliance Foundation Trials, LLC.
10 Previous Clinical Trials
6,454 Total Patients Enrolled

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04062708 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Treatment
Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04062708 — Phase 2
Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04062708 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned Radiotherapy as a viable medical treatment?

"As a Phase 2 trial, there is some data suggesting safety but none to back up its efficacy. Therefore we have assigned Radiotherapy a score of 2 on our 1-3 scale."

Answered by AI

Are there currently open enrollments for this research endeavor?

"According to clinicaltrials.gov, this experiment is still enrolling participants since it was originally published on March 10th 2021 and last modified on December 7h 2021."

Answered by AI

What types of illnesses have seen successful treatment through radiotherapy?

"Radiotherapy is a common approach to treating unresectable stage iii non-small cell lung cancer. Additionally, this technique has been used in the treatment of metastatic urothelial carcinoma and advanced directives."

Answered by AI

What other investigations have been conducted involving Radiotherapy?

"Radiotherapy was initially researched in 2010 at City of Hope and has since been subject to 343 trials. Currently, 333 active studies are taking place around the world; notably, a large concentration is based out of Houston, Texas."

Answered by AI

How many facilities are presently administering this clinical investigation?

"This trial has 18 sites across the United States, including in Houston, Durham and Oklahoma City. As such, it is paramount for potential participants to pick a medical centre nearby to reduce any necessary travel expenses."

Answered by AI

What is the aggregate number of people participating in this investigation?

"Indeed. According to the clinicaltrials.gov portal, this medical trial is currently open for recruitment and was initially posted on March 10th 2021 with a recent update of December 7th 2021. The study seeks 55 participants from 18 different sites."

Answered by AI
Recent research and studies
~14 spots leftby Dec 2025