Study on Durvalumab and Chemotherapy Before and After Surgery for Treating Resectable Non-small Cell Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT03800134

This Phase III clinical trial is testing whether adding the drug durvalumab to chemotherapy before surgery can improve treatment outcomes for patients with resectable non-small cell lung cancer (NSCLC), compared to chemotherapy alone.

Patient Parameters

Program Overview

This international study is exploring the effectiveness of using durvalumab, an immunotherapy drug, along with chemotherapy before surgery in patients with resectable non-small cell lung cancer (NSCLC). The trial aims to see if this combination can lead to a better pathological complete response, meaning no signs of cancer in tissue samples after treatment, compared to using chemotherapy alone with a placebo.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a new diagnosis of non-small cell lung cancer (NSCLC) that can be surgically removed, specifically in stages IIA to certain types of stage IIIB.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have at least one measurable tumor that has not been treated with radiation.
  • Have not received any previous immune-based cancer treatments.
  • Have adequate organ and bone marrow function.
  • Have a confirmed PD-L1 status of the tumor.
  • Provide a tumor biopsy sample to check for specific genetic markers (EGFR and ALK).
  • Plan to have surgery that involves removing part of the lung (lobectomy, sleeve resection, or bilobectomy).

Exclusion Criteria

  • Have had an organ transplant from another person.
  • Have active or past autoimmune or inflammatory diseases, such as lupus or inflammatory bowel disease.
  • Have had another type of cancer in the past.
  • Have a primary immune deficiency.
  • Have an active infection like tuberculosis, hepatitis B or C, or HIV.
  • Have lung cancer that cannot be surgically removed.
  • Have received radiation therapy before surgery as part of the treatment plan.
  • Have cancer that has spread to the brain or spinal cord.
  • Have advanced stages of lung cancer (Stage IIIB N3, IIIC, IVA, or IVB).
  • Have an allergy to any of the study drugs.
  • Have more than one type of lung cancer.
  • Plan to have surgery that involves removing the entire lung or smaller parts like segments or wedges.
  • Have specific genetic changes in the tumor (EGFR mutation or ALK translocation).

Locations

FACILITYZIPCITYSTATE
Research Site85054PhoenixArizona
Research Site91010DuarteCalifornia
Research Site92868OrangeCalifornia
Research Site80012AuroraColorado
Research Site33486Boca RatonFlorida
Research Site32256JacksonvilleFlorida
Research Site60612ChicagoIllinois
Research Site67214WichitaKansas
Research Site41101AshlandKentucky
Research Site40513LexingtonKentucky

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