Official Title: A Phase II Multicenter, Open Label, Non-randomized Study of Neoadjuvant and Adjuvant Treatment With IPH5201 and Durvalumab in Patients With Resectable, Early-stage (II to IIIA) Non-Small Cell Lung Cancer (MATISSE)
Innate Pharma
Summary
The study is intended to assess the safety and efficacy of neoadjuvant combination of IPH5201 and durvalumab in addition to standard chemotherapy and adjuvant combination of IPH5201 and durvalumab in untreated patients with resectable, early-stage (stage II to IIIA) non-small cell lung cancer (NSCLC).
Description
This is an open-label, single-arm multicenter study. Eligible patients will be enrolled and will receive IPH5201 + Durvalumab + standard of care chemotherapy before surgery followed by IPH5201 + Durvalumab post-surgery.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC resectable (Stage IIA to Stage IIIA) disease (according to Version 8 of IASLC Staging Manual in Thoracic Oncology 2016. 2. WHO Performance Status or Eastern Cooperative Oncology Group of 0 or 1. 3. Adequate organ and marrow function. 4. Must have a life expectancy of at least 12 weeks. 5. Body weight \> 35 kg. 6. Females of childbearing potential should use an acceptable method of contraception from the time of screening throughout the total duration of the study. 7.…
Interventions
- DrugIPH5201 + durvalumab + standard chemotherapy
Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy. Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab.
Locations (30)
- St. Anthony's Hospital - BayCare Health SystemSt. Petersburg, Florida
- H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida
- University of Chicago Medical CenterChicago, Illinois
- Northwell Health Cancer Institute / Center for Novel Cancer TherapeuticsLake Success, New York
- Millennium Research & Clinical DevelopmentHouston, Texas
- UW Carbone Cancer Center - Cancer ConnectMadison, Wisconsin