Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE)

Description

The purpose of this study is to assess efficacy and safety of neoadjuvant durvalumab in combination with platinum-based chemotherapy (CT) given as initial therapy after cancer diagnosis followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab given alone as further therapy in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.

Conditions

Non-small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

The purpose of this study is to assess efficacy and safety of neoadjuvant durvalumab in combination with platinum-based chemotherapy (CT) given as initial therapy after cancer diagnosis followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab given alone as further therapy in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.

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)

Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE)

Condition
Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Duarte

Research Site, Duarte, California, United States, 91010

Stuart

Research Site, Stuart, Florida, United States, 34994

Chicago

Research Site, Chicago, Illinois, United States, 60611

Bronx

Research Site, Bronx, New York, United States, 10467

Durham

Research Site, Durham, North Carolina, United States, 27710

Houston

Research Site, Houston, Texas, United States, 77030

Charlottesville

Research Site, Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Deemed resectable or borderline resectable at baseline, confirmed by MDT evaluation at diagnosis.
  • * Previously untreated and pathologically confirmed Stage IIB to select \[i.e.N2\] Stage IIIB by AJCC v8.
  • * Nodal status confirmed with whole body FDG-PET and biopsy via endobronchial ultrasound, mediastinoscopy, or thoracoscopy.
  • * Mandatory brain MRI.
  • * EGFR and ALK wild-type.
  • * Medically operable: adequate cardiac and lung function to undergo resection.
  • * Participant must be ≥ 18 years, at the time of screening.
  • * Histologically or cytologically documented NSCLC.
  • * Minimum life expectancy of 12 weeks.
  • * Minimum body weight of 30 kg.
  • * Male and female participants must be willing to use acceptable methods of contraception.
  • * Female participants of childbearing potential must have negative pregnancy test.
  • * Unresectable NSCLC confirmed by MDT evaluation at baseline
  • * Stage IIIC patients
  • * Participants whose planned surgery at enrollment is a wedge resection
  • * Known EGFR mutation or ALK translocation
  • * Participants contraindicated for surgical intervention due to comorbid conditions
  • * Participants who are allergic to study intervention.
  • * Participants with more than one primary tumour.
  • * Known active hepatitis infection, positive HCV antibody, HBsAg or HBV core antibody (anti-HBc), at screening.
  • * Female participants who are pregnant or breastfeeding.
  • * Judgement by the investigator that the participant should not participate in the study.
  • * Previously infected or tested positive for human immunodeficiency virus.

Ages Eligible for Study

18 Years to 130 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2027-08-27