NCT05267392

Neoadjuvant Immunotherapy With Durvalumab (MEDI4736) in Non-Surgical Early Stage or Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Followed by Radical Radiotherapy or Chemoradiotherapy

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study proposes to evaluate the safety and efficacy of an anti-PD-L1 (durvalumab) agent as neoadjuvant therapy in patients diagnosed with localized NSCLC who are planned to undergo radical RT or CRT. The hypothesis to be tested for the primary objective is that the treatment of durvalumab followed by RT/CRT will be safe and well tolerated in subjects with NSCLC.

Detailed description

Targeting the PD1/PD-L1 pathway has demonstrated activity in patients with several advanced malignancies. Treatment with anti-PD1/PD-L1 blockade in advanced and, more recently, locally advanced NSCLC, is already standard of care. The positive outcomes of durvalumab following CRT emphasized the potential of immunotherapy integration in multimodality treatment strategies and in earlier phases of the disease, leading to the first immune checkpoint inhibitor approval in non-metastatic setting in NSCLC. Furthermore, growing evidence is pointing to the efficacy of neoadjuvant treatments in NSCLC. This study proposes to evaluate the safety and efficacy of an anti-PD-L1 (durvalumab) agent as neoadjuvant therapy in patients diagnosed with localized NSCLC who are planned to undergo radical RT or CRT. The hypothesis to be tested for: * Primary objective: To evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of durvalumab followed by RT/CRT in patients with early stage or locally advanced, unresectable NSCLC who are planned to undergo radical RT or CRT. * Secondary Objectives: To evaluate the safety, the efficacy and the feasibility of durvalumab followed by RT/CRT. * Exploratory Objectives: To assess the Quality of Life (QoL) using SF-36v2 and EQ-5D-5L and to assess blood and tumor tissue for potential biomarkers which predict and/or correlate with clinical outcomes.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Patients will receive 1500 mg of durvalumab (MEDI4736) via IV infusion
OTHER	standard of care RT/RCT	standard of care RT/RCT

Timeline

• Start date: 2021-02-16
• Primary completion: 2023-07-01
• Completion: 2024-01-01
• First posted: 2022-03-04
• Last updated: 2022-03-04

Locations

1 site across 1 country: Portugal