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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
Pathological Complete Response (pCR)
Number of patients with pathological Complete Response (pCR)
Time frame: 16 weeks after the first dose of study intervention.
Adverse events (AEs) and serious adverse events (SAEs)
Number of patients with adverse events (AEs) and serious adverse events (SAEs).
Time frame: Until Day 90 after the last dose of study interventions.
Event-Free Survival (EFS)
Number of patients experiencing an Event-Free Survival (EFS) event.
Time frame: Up to approximately 2 years.
Disease Free Survival (DFS)
Number of patients experiencing a Disease Free Survival (DFS) event (event from surgery onwards).
Time frame: Up to approximately 2 years.
Surgical resection
Number of participants having surgical resection.
Time frame: Approximately 16 weeks after the first dose of study intervention.
Major Pathological Response (mPR)
Number of patients with a major Pathological Response (mPR).
Time frame: Approximately 16 weeks after the first dose of study intervention.
Objective Response Rate (ORR)
Number of patients with an Objective Response Rate (ORR).
Time frame: Up to approximately 4 months adjuvant.
Overall Survival (OS)
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St. Anthony's Hospital - BayCare Health System
St. Petersburg, Florida, United States
RECRUITINGH. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
RECRUITINGUniversity of Chicago Medical Center
Chicago, Illinois, United States
NOT_YET_RECRUITINGNorthwell Health Cancer Institute / Center for Novel Cancer Therapeutics
Lake Success, New York, United States
NOT_YET_RECRUITINGMillennium Research & Clinical Development
Houston, Texas, United States
RECRUITINGUW Carbone Cancer Center - Cancer Connect
Madison, Wisconsin, United States
RECRUITINGAngers University Hospital Center
Angers, France
RECRUITINGUniversity Hospital Center Caen
Caen, France
RECRUITINGHospital Calmette
Lille, France
NOT_YET_RECRUITINGCHU de Limoges
Limoges, France
RECRUITING...and 20 more locations
Overall Survival (OS).
Time frame: Up to approximately 2 years.
PK of IPH5201 in combination with durvalumab +/- chemotherapy
Serum concentration (PK) of IPH5201 in combination with durvalumab +/- chemotherapy, in patients receiving neoadjuvant and adjuvant treatment.
Time frame: Up to approximately 4 months adjuvant.
Anti-study drug antibodies (ADA)
Number of patients with anti-study drug antibodies (ADA).
Time frame: Up to approximately 4 months adjuvant.