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

NCT05696782 Phase 2 RECRUITING

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.

Details

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2
Status	RECRUITING
Enrolment	28
Start date	2023-07-26
Completion	2027-04

Conditions

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

Interventions

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

Primary outcomes

• Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days) — 48 weeks
  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.

Countries

United States