Quick start of Durvalumab after chemotherapy and radiation for advanced lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Atrium Health Levine Cancer
  Charlotte, North Carolina, United States Recruiting
• 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: Jada Kluttz
• Email: Jada.Kluttz@Advocatehealth.org
• Phone: 336-713-0901

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.