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)

Part of paid clinical trials in The Bronx, New York.

Sponsor
AstraZeneca
Study ID
NCT05925530
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Participants that go on to receive surgery, will receive durvalumab for up to four cycles prior to surgery. Participants that go on to receive CRT will receive durvalumab for up to two cycles prior to CRT. All participants will receive durvalumab every four weeks until disease progression or recurrence or up to 12 months following surgery/CRT, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Study Details

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.

Key Dates

First listed
Jun 29, 2023
Start date
Feb 22, 2024
Status verified
Jun 2026
Primary completion
Jan 12, 2026
Completion
Aug 27, 2027

Study Design

Enrollment
142 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab
    Durvalumab will be administered to the participants via intravenous infusion (IV)

Primary Outcome Measure

Resection rate [ Time Frame: At day of surgery (Within 40 days of the last dose of neoadjuvant treatment) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteThe BronxNew York10467-
Research SiteHoustonTexas77030-
Research SiteCharlottesvilleVirginia22908-

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