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AZ Bridge-neoadjuvant treatment for NSCLC (Non-Small Cell Lung Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if a drug called durvalumab (the study drug) is a safe and effective option for patients with resectable or borderline resectable (Stage IIB to IIIB) NSCLC. We will compare how well the study drug works versus the usual treatment for this type of cancer. Durvalumab is approved for the treatment of advanced NSCLC after chemotherapy and radiation, but it is still considered experimental for less advanced forms of NSCLC.

What is the Condition Being Studied?

Stage IIB-IIIB Non-Small Cell Lung Cancer (NSCLC)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with Stage IIB-IIIB NSCLC
  • Weigh at least 66 pounds

For more information about who can join this study, contact the study team at annmarie.peters@duke.edu.

Age Group
Adults

What is Involved?

If you join this study, you will get 2 cycles of whatever chemotherapy your doctor believes is most appropriate. During these cycles, you will also take the study drug every 3 weeks. Both the study drug and chemotherapy are given as infusions into one of your veins (IV).

After you finish these first 2 cycles of chemotherapy + the study drug, the study doctor will determine whether or not you are able to have surgery to remove your tumor(s). If you are eligible to have surgery, you will be part of Cohort 1 of this study. If you are not eligible for surgery, you will be in Cohort 2.

If you are in Cohort 1, you will:

  • Get an additional 1-2 cycles of the study drug regimen before your surgery
  • Have surgery
  • Continue takng the study drug for up to 12 cycles following surgery

If you are in Cohort 2, you will:

  • Get chemotherapy + radiation for about 6 weeks
  • Continue the study drug for up to 12 cycles following chemotherapy + radiation

Study Details

Full Title
AstraZeneca AB/A multicentre, Phase II, single-arm, interventional study of neoadjuvant durvalumab and platinum-based chemotherapy (CT), followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, in participants with resectable or borderline resectable stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC)
Principal Investigator
Protocol Number
IRB: PRO00115237
NCT: NCT05925530
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
More Information