Innate Pharma
In Cohort 1, the study was intended to assess 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). Study Design was updated following the results of interim analysis # 2 (protocol amendment, adding cohort 2). Cohort 2 includes patients with resectable Stage II to IIIB NSCLC expressing PD-L1 ≥1%, receiving (only) neoadjuvant IPH5201+ durvalumab + chemotherapy
Currently enrolling in Cohort 2: this is an open-label, single-arm multicenter study. Eligible NSCLC patients PD-L1 ≥1% will be enrolled and will receive IPH5201 + Durvalumab + standard of care chemotherapy before surgery.
Inclusion criteria Patients are eligible to be included in the study only if all of the following criteria apply: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol. 2. Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses - including collection of samples for genetic analysis, if applicable. 3. Patients must be ≥18 years at the time of screening. 4. Newly diagnosed and previously untreated patients with histol…
Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy. In Cohort 1 only, Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab.