Quick start of Durvalumab after chemotherapy and radiation for advanced lung cancer
Phase II Pilot Study of Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
PHASE2 · Wake Forest University Health Sciences · NCT05696782
This study is testing if starting Durvalumab treatment right after chemotherapy and radiation can help people with advanced lung cancer feel better and improve their outcomes.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Drugs / interventions | durvalumab, chemotherapy, radiation, prednisone |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05696782 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of initiating Durvalumab treatment within 14 days after completing chemotherapy and radiation therapy in patients with unresectable Stage II or III nonsmall cell lung cancer. The primary objective is to assess the fidelity of early Durvalumab initiation, while secondary objectives include evaluating the feasibility of starting treatment even earlier, identifying logistical barriers, and comparing the toxicity and efficacy of this approach to historical controls. Participants will be monitored for both positive and negative effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with unresectable Stage II or III nonsmall cell lung cancer who have recently completed chemotherapy and radiation.
Not a fit: Patients with resectable lung cancer or those who have not undergone recent chemotherapy and radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced lung cancer by enabling quicker access to Durvalumab therapy.
How similar studies have performed: While there have been studies on Durvalumab, this specific approach of quick initiation post-chemoradiation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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.
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.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Thomas Lycan, MD — Wake Forest Baptist Comprehensive Cancer Center
- Study coordinator: Study Coordinator
- Email: Jada.Kluttz@wakehealth.edu
- Phone: 336-713-0901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nonsmall Cell Lung Cancer Stage III, Unresectable Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Stage II