Clinical trial NCT05696782: Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
Official title: Phase II Pilot Study of Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nonsmall Cell Lung Cancer Stage III
Unresectable Non-Small Cell Lung Carcinoma
Nonsmall Cell Lung Cancer, Stage II
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Primary Objective: Assess the treatment fidelity for early Durvalumab initiation (i.e., within 14 days after the last day of radiation therapy) following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.

Secondary Objectives:

* Assess the treatment fidelity for very early Durvalumab initiation (i.e., within seven days after the last day of radiation therapy) following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
* Assess barriers to earlier Durvalumab initiation following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
* Describe the toxicity of Durvalumab when initiated quickly after chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer as compared to historical controls.
* Describe the efficacy of Durvalumab when initiated quickly after chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer as compared to historical controls.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)
timeFrame: 48 weeks
Secondary outcomes:
measure: Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Very Early (1-7 days)
timeFrame: Up to 13 months
measure: Number of Barriers to Initiation of Durvalumab - Very Early (Days 1-7)
timeFrame: Up to 13 months
measure: Number of Barriers to Initiation of Durvalumab - Early (Days 8-14)
timeFrame: Up to 13 months
measure: Number of Participants with All Adverse Events
timeFrame: Up to 13 months after intervention
measure: Number of Participants Who Have Immune-Mediated Pneumonitis - Early Fidelity (1-14 days)
timeFrame: Within 85 days of intervention (Cycles 1-3)
measure: Number of Participants Who Have All-Cause Any Grade Pneumonitis - Early Fidelity (1-14 days)
timeFrame: Within 85 days of intervention (Cycles 1-3)
measure: Number of Participants to Discontinue Durvalumab Due to Adverse Events
timeFrame: One year
measure: Overall Survival
timeFrame: One year
measure: Progression-Free Survival
timeFrame: One year
measure: Response Rate
timeFrame: One year
Other outcomes:
measure: 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
timeFrame: Baseline to 12 weeks after start of intervention
measure: Change in Patient-Reported Outcomes Scores (PROs) - Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Questionnaire
timeFrame: Baseline to 12 weeks after start of intervention
measure: Change in Respiratory Patient Reported Outcomes (PROs) - COPD Assessment Test (CAT)
timeFrame: Baseline to 12 weeks after start of intervention
measure: Change in Respiratory Patient Reported Outcomes (PROs) - Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: Baseline to 12 weeks after start of intervention
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Thomas Lycan, MD
role: PRINCIPAL_INVESTIGATOR
References: