RECRUITING

Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer

Conditions

Nonsmall Cell Lung Cancer Stage III Unresectable Non-Small Cell Lung Carcinoma Nonsmall Cell Lung Cancer, Stage II

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study aims to determine what effects (good and bad) Durvalumab has on participants and their cancer with a "quick start" of Durvalumab within 14 days of finishing chemotherapy and radiation. The study will also determine the logistic barriers to the quick start of Durvalumab.

Official Title

Phase II Pilot Study of Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer

Quick Facts

Study Start:2023-07-26

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05696782

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must have Stage II or Stage III nonsmall cell lung cancer confirmed by histologic or cytologic documentation and by clinical assessment. Staging is defined according to the American Joint Committee on Cancer Staging Manual, 8th Edition (2017). * Unresectable or medically inoperable as determined by the investigator. * The participant has definitive radiation therapy (e.g., 54 Gy to 66 Gy in 30 to 35 fractions) for lung cancer that is either (a) planned to start within the next 28 days, or (b) currently being administered, or (c) has been completed within the last 14 days. * Platinum-based chemotherapy for lung cancer that is either (a) planned to start within the next 28 days, (b) currently being administered, or (c) has been completed within the last 14 days. Chemotherapy must be for at least two cycles and be administered either before radiation therapy ("induction" or "sequential") or during radiation therapy ("concurrent"). * Consolidation Durvalumab is planned for nonsmall cell lung cancer after radiation and chemotherapy. * Eighteen years old or greater. * ECOG performance status of 0-2. * Life expectancy of greater than three months. * Patients with sexual relationships in which either they or their partner may become pregnant must use contraception during the study treatment period. * Ability to understand and be willing to sign an IRB-approved informed consent document directly or via a legally authorized representative.	* Uncontrolled respiratory symptoms (i.e., cough, dyspnea, fevers, chest pain, or an increase from baseline oxygen requirements) that are interfering with activities of daily living. * Nonsmall cell lung cancer is known to have a tumor with a mutation in EGFR associated with sensitivity to first-line therapy with a tyrosine kinase inhibitor (i.e., Ex19del or L858R). Testing for EGFR mutation must have been attempted for study enrollment. If EGFR testing is inconclusive (e.g., the biopsy's quantity or quality is not sufficient for testing to be performed) and there is low clinical suspicion for the presence of an EGFR mutation as determined by the investigator, then the patient is eligible. * Prior exposure to an immune checkpoint inhibitor targeting CTLA-4, PD-1, or PD-L1. * Active autoimmune disease requiring systemic immunosuppression at the time of enrollment. * History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone \>20 mg/day for more than one week). * Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients who are pregnant or breastfeeding.

Inclusion Criteria

Exclusion Criteria

* Patients must have Stage II or Stage III nonsmall cell lung cancer confirmed by histologic or cytologic documentation and by clinical assessment. Staging is defined according to the American Joint Committee on Cancer Staging Manual, 8th Edition (2017).
* Unresectable or medically inoperable as determined by the investigator.
* The participant has definitive radiation therapy (e.g., 54 Gy to 66 Gy in 30 to 35 fractions) for lung cancer that is either (a) planned to start within the next 28 days, or (b) currently being administered, or (c) has been completed within the last 14 days.
* Platinum-based chemotherapy for lung cancer that is either (a) planned to start within the next 28 days, (b) currently being administered, or (c) has been completed within the last 14 days. Chemotherapy must be for at least two cycles and be administered either before radiation therapy ("induction" or "sequential") or during radiation therapy ("concurrent").
* Consolidation Durvalumab is planned for nonsmall cell lung cancer after radiation and chemotherapy.
* Eighteen years old or greater.
* ECOG performance status of 0-2.
* Life expectancy of greater than three months.
* Patients with sexual relationships in which either they or their partner may become pregnant must use contraception during the study treatment period.
* Ability to understand and be willing to sign an IRB-approved informed consent document directly or via a legally authorized representative.

* Uncontrolled respiratory symptoms (i.e., cough, dyspnea, fevers, chest pain, or an increase from baseline oxygen requirements) that are interfering with activities of daily living.
* Nonsmall cell lung cancer is known to have a tumor with a mutation in EGFR associated with sensitivity to first-line therapy with a tyrosine kinase inhibitor (i.e., Ex19del or L858R). Testing for EGFR mutation must have been attempted for study enrollment. If EGFR testing is inconclusive (e.g., the biopsy's quantity or quality is not sufficient for testing to be performed) and there is low clinical suspicion for the presence of an EGFR mutation as determined by the investigator, then the patient is eligible.
* Prior exposure to an immune checkpoint inhibitor targeting CTLA-4, PD-1, or PD-L1.
* Active autoimmune disease requiring systemic immunosuppression at the time of enrollment.
* History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone \>20 mg/day for more than one week).
* Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients who are pregnant or breastfeeding.

Contacts and Locations

Study Contact

Study Nurse

CONTACT

3367137748

saverill@wakehealth.edu

Principal Investigator

Thomas Lycan, MD

PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Study Locations (Sites)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Thomas Lycan, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Baptist Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-26

Study Completion Date2026-07

Study Record Updates

Study Start Date2023-07-26

Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

Nonsmall Cell Lung Cancer Stage III
Unresectable Non-Small Cell Lung Carcinoma
Nonsmall Cell Lung Cancer, Stage II