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

Wake Forest University (WFU)

Status and phase

Enrolling

Phase 2

Conditions

Unresectable Non-Small Cell Lung Carcinoma

Nonsmall Cell Lung Cancer Stage III

Nonsmall Cell Lung Cancer, Stage II

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05696782

IRB00092850

WFBCCC 62422 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.