IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)
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).
| Condition(s) | Non Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | 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. Negative pregnancy test (serum or urine) for women of childbearing potential. 8. Provision of tumor samples (newly acquired \[preferred\] or archival tumor tissue \[≤ 6 months old\]) to confirm Program |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Innate Pharma |
| Locations | St. Petersburg, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Lake Success, New York, United States; Houston, Texas, United States; Madison, Wisconsin, United States (+24 more sites) |
| Start date | 2023-06-23 |
| NCT ID | NCT05742607 |
| Official listing | https://clinicaltrials.gov/study/NCT05742607 |