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 — DRUGParticipants 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
- Start date
- Feb 22, 2024
- Status verified
- Apr 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: DurvalumabDurvalumab 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | The Bronx | New York | 10467 | - |
| Research Site | Houston | Texas | 77030 | - |
| Research Site | Charlottesville | Virginia | 22908 | - |
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