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

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

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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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

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

David
Harpole

Protocol Number

PRO00115237

NCT ID

NCT05925530

Phase

II

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov