NCT03030131

Immune Neoadjuvant Therapy Study of Durvalumab in Early Stage Non-small Cell Lung Cancer

A Phase II Prospective Immune Neoadjuvant Therapy Study od Durvalumab (MEDI4736) in Early Stage Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA) NSCLC is curative surgery. Although patients treated with curative surgery have a better prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative chemotherapy versus no chemotherapy have shown a significant overall survival benefit from postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA. Likewise other randomized trials have demonstrated preoperative chemotherapy improves survival and recently the analyses also based on individual patients data of 15 randomized trials showed a significant benefit of preoperative chemotherapy on survival with the same survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become accepted in many countries. Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an attractive therapeutic option in the early stage NSCLC, which may reactivate host immune responses and enable longterm tumor control.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Durvalumab	durvalumab 750 mg IV Day1, 15, 29

Timeline

• Start date: 2017-01-12
• Primary completion: 2019-08-28
• Completion: 2019-08-28
• First posted: 2017-01-24
• Last updated: 2023-03-14

Locations

31 sites across 1 country: France