Clinical Trial 21525

• Overview

  Study Title:

  A Feasibility Study of Genomically Guided Radiation Dose Personalization in the Management of Locally Advanced Non-Small Cell Lung Cancer

  Summary:

  The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) with concurrent chemotherapy in the management of stage II and III non-small cell lung cancer (NSCLC).

  Objective:

  Primary: * To evaluate the number of enrolled participants able to undergo biopsy with successful estimation of RxRSI and delivery of a clinically acceptable radiation treatment plan to deliver personalized radiotherapy among patients with unresectable locally advanced NSCLC. Secondary Objectives: * To determine safety following genomically guided dose escalation among patients with locally advanced unresectable NSCLC * To determine the two year freedom from local regional progression following genomically guided dose escalation among patients with unresectable locally advanced NSCLC. * To determine the median and 2 year OS following genomically guided dose escalation among patients with locally advanced unresectable NSCLC

• Treatments

  Therapies:

  Radiotherapy

  Medications:

  Radiotherapy ()

• Inclusion Criteria

  • Diagnosis of AJCC Stage 2 or Stage 3 unresectable NSCLC as determined by a multidisciplinary oncology team
  • Confirmation of NSCLC with availability of fresh tumor biopsy by tissue biopsy which can include adenocarcinoma, squamous cell, large cell carcinoma, or NSCLC not otherwise specified
  • Life expectancy >12 weeks
  • Adequate organ function
  • ECOG 0-1
  • Age >18 years
  • Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
  • There is no limit on prior systemic or therapies
  • Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
  • Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before any study related procedures occur.

• Exclusion Criteria

  • Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of the first dose of study treatment
  • Major surgery or significant traumatic injury that has not been recovered from 14 days before the initiation of study drug
  • Women who are pregnant or breastfeeding
  • History of allergy or hypersensitivity to any of the study drugs or study drug components
  • Concurrent brain metastases or leptomeningeal disease
  • History of prior malignancy within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of > 90%), such as but not limited to, non-melanoma skin carcinoma, ductal carcinoma in situ, or stage I endometriod uterine cancer, and others at the discretion of the PI
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
  • a. Patients with vitiligo or alopecia
  • b. Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
  • c. Any chronic skin condition that does not require systemic therapy
  • d. Patients without active disease in the last 5 years may be included but only after consultation with the Principal Investigator
  • Patients with celiac disease controlled by diet alone
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
  • a. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection)
  • b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • c. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)

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