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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the good and bad effects of starting durvalumab within 14 days after finishing chemotherapy and radiation. It is for adults with stage II or III non-small cell lung cancer that cannot be removed by surgery. The study also looks at practical problems that may delay starting durvalumab.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with stage II or III non-small cell lung cancer confirmed by tissue or cell tests and a medical exam.
  • Have cancer that cannot be removed by surgery, or be unable to have surgery for medical reasons.
  • Have lung cancer radiation planned within 28 days, underway now, or finished within the past 14 days.
  • Have platinum-based chemotherapy planned within 28 days, underway now, or finished within the past 14 days. At least two treatment cycles must be given before or during radiation.
  • Plan to receive durvalumab after chemotherapy and radiation.
  • Be able to care for yourself and be up and about at least half of your waking hours. Be expected to live more than three months.
  • Use birth control during study treatment if you or your partner could become pregnant.
  • Be able to understand and agree to join by signing a consent form, either yourself or through a legally authorized representative.

Who can't join

  • Have uncontrolled symptoms such as cough, trouble breathing, fever, chest pain, or a need for more oxygen that affect daily activities.
  • Have certain EGFR gene changes in the cancer that respond to targeted medicines. EGFR testing must be tried. Unclear results may be allowed if the study doctor thinks these changes are unlikely.
  • Have previously received immune checkpoint drugs targeting CTLA-4, PD-1, or PD-L1. These drugs help the immune system attack cancer.
  • Have an active autoimmune disease, where the immune system attacks the body, that needs medicine to weaken the immune system throughout the body.
  • Have had lung swelling caused by the immune system that needed high-dose steroids: more than 20 mg of prednisone daily, or an equal dose, for over one week.
  • Have an uncontrolled illness, such as an infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat, or mental health or social problems that would make study rules hard to follow.
  • Be pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (2)

NC