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)

AstraZeneca

Status and phase

Active, not recruiting

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Durvalumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05925530

2023-503357-35-00 (Registry Identifier)

D9106C00002

Details and patient eligibility

About

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.

Full description

This will be a multicentre, Phase II, single-arm, global study assessing the efficacy and safety of neoadjuvant durvalumab and platinum-based CT, given intravenously, followed by either surgery and adjuvant durvalumab or definitive CRT and consolidation durvalumab in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.

Neoadjuvant Period A:

All participants will initially receive 2 cycles of neoadjuvant durvalumab + CT (investigator's choice platinum-based) every three weeks. Participants will be assessed for resectability by a multidisciplinary team.

Neoadjuvant Period B:

Cohort 1: Participants who are deemed eligible for surgery will receive study intervention every three weeks for an additional one and up to two cycles, followed by surgery.

CRT:

Cohort 2: Participants with unresectable tumours (according to MDT re-assessment) will receive definitive CRT (6 one-week cycles) for approximately six weeks.

Both cohorts will then go on to receive durvalumab every four weeks until disease progression or recurrence or up to one year.

Enrollment

142 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion 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.

Exclusion criteria

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.