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

NCT05696782 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB00092850WFBCCC 62422P30CA012197
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)

  Fidelity is defined as a dichotomous composite indicator (yes/no) that describes whether the patient received very early (1-7 days) or early (days 8-14 days) initiation of Durvalumab as per protocol with all four of the following criteria having been met: (i) CT chest obtained after the last day of radiation therapy and before the first infusion of Durvalumab, (ii) first infusion within 14 days of completing radiation therapy, (iii) second and third doses received within 63 days of the first dose, and (iv) all infusions at least 28 days apart.

  48 weeks

Secondary Outcomes (10)

• Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Very Early (1-7 days)

  Up to 13 months

• Number of Barriers to Initiation of Durvalumab - Very Early (Days 1-7)

  Up to 13 months

• Number of Barriers to Initiation of Durvalumab - Early (Days 8-14)

  Up to 13 months

• Number of Participants with All Adverse Events

  Within 85 days of intervention (Cycles 1-3)

• Number of Participants Who Have Immune-Mediated Pneumonitis

  Within 85 days of intervention (Cycles 1-3)

Other Outcomes (5)

• Change in Patient-Reported Outcomes Scores (PROs) - European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Version 3

  Baseline to cycle 4 (85 days) after start of intervention

• Change in Patient-Reported Outcomes Scores (PROs) - Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Questionnaire

  Baseline to cycles 4 (day 85), cycle 7 (day 169), cycle 10 (day 253) and cycle 13 (day 337) after start of intervention

• Change in Respiratory Patient Reported Outcomes (PROs) - COPD Assessment Test (CAT)

  Baseline to cycles 4 (day 85), cycle 7 (day 169), cycle 10 (day 253) and cycle 13 (day 337) after start of intervention

Study Arms (1)

Quick Start Durvalumab

EXPERIMENTAL

Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion

Drug: Durvalumab; Other: the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30); Diagnostic Test: COPD Assessment Test (CAT); Diagnostic Test: Modified Medical Research Council (mMRC) dyspnea scale

Interventions

Durvalumab DRUG

Participants will receive Durvalumab 1500 mg intravenously every two weeks for 60 minutes. Each treatment is called a cycle and lasts for four weeks (or 28 days).

Quick Start Durvalumab

COPD Assessment Test (CAT) DIAGNOSTIC_TEST

Participants will be asked to answer all items on the COPD assessment test (8 items) and the patient-reported outcome measures designed to measure respiratory function. The measures can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is less than 5 minutes.

Quick Start Durvalumab

Modified Medical Research Council (mMRC) dyspnea scale DIAGNOSTIC_TEST

Participants will be asked to answer the modified medical research council dyspnea scale (1 item), and the patient-reported outcome measures designed to measure respiratory function. The measures can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is less than 5 minutes.

Quick Start Durvalumab

the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) OTHER

Participants will be asked to answer all 30 items on the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). This patient-reported outcome measure is designed to measure cancer patients' physical, psychological and social functions. The measure can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is approximately 11 minutes (

Quick Start Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have stage II or stage III NSCLC confirmed by histologic or cytologic documentation and by clinical assessment. Staging is defined according to the AJCC Cancer Staging Manual, 8th Edition (2017).
• Unresectable or medically inoperable as determined by the investigator.
• The patient 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 NSCLC 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thomas Lycan, MD

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

336-713-0901; Jada.Kluttz@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 25, 2023
• Study Start: July 26, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)