A Study to Determine the Most Effective Sequence of Treatment with Pembrolizumab abd Standard of Care Chemotherapy in Patients with Non-Small Cell Lung Cancer

What we are studying

Stage IV Non Small Cell Lung Cancer has been treated with chemotherapy, chemotherapy with antibodies, or a combination of chemotherapy historically. Depending on the stage and other characteristics of your lung cancer, this treatment plan may include surgery, chemotherapy, radiation, or a combination of these therapies. The purpose of this study is to determine if the administration of standard platinum-based chemotherapy before pembrolizumab, in patients with stage IV non – small cell lung cancer (NSCLC) who have not previously been treated with chemotherapy (chemotherapy naïve), will improve the overall response rate (ORR) compared to pembrolizumab administered before or concurrently with chemotherapy. Pembrolizumab is an antibody designed to block receptors that inhibit the antitumor immune response. By blocking the inhibitory pathway, pembrolizumab allows the immune system to target cancer cells. We are still learning about methods of treatment that are less harmful to individuals. We hope to learn more about safe and effective treatment in this study.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Have a lifespan of at least 3 months
  • Have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC)
  • Have provided tissue from a previous biopsy or will provide tissue
  • Must have tissue with PD-L1 positive status
  • If you are a female of childbearing years
  • Must use 2 adequate forms of birth control
  • And males must agree to use an adequate form of birth control. You cannot participate in this study if you:
    • Are pregnant or breastfeeding
  • Have received prior treatment with chemotherapy or biologic therapy for NSCLC
  • Are currently participating in another clinical trial with investigational product or have been within 4 weeks of treatment
  • Have another known malignancy that requires active treatment
  • Have a central nervous system metastases and/or carinomatous meningitis
  • Have an autoimmune disease
  • Have active infection
  • Have other lung disease
  • Have psychiatric or substance abuse disorders
  • Have known HIV
  • Hepatitis B or Hepatitis C
  • Have received a vaccine within 30 days of first treatment
  • Have a known history of TB (baccillus Tuberculosis)

What is involved

  • Physical exams
  • Vital signs and weight
  • Pregnancy tests
  • Blood draws
  • CT scans
  • Potential newly obtained tissue collection (if archived one is not available)

Compensation

None

Contact Information

Study Coordinator
Sharon Averill, RN, CCRP
Email
[email protected]
Phone
(336)-713-7748
Principal Investigator
William Jeffrey Petty, MD

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Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.