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
Overview
- Phase
- Phase 1
- Intervention
- Durvalumab
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Incidence of Dose-Limiting Toxicity (DLT)
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Durvalumab
All subjects enrolled in the study will receive open-label neoadjuvant durvalumab 1500 mg followed by standard of care RT/RCT
Intervention: Durvalumab
Durvalumab
All subjects enrolled in the study will receive open-label neoadjuvant durvalumab 1500 mg followed by standard of care RT/RCT
Intervention: standard of care RT/RCT
Outcomes
Primary Outcomes
Incidence of Dose-Limiting Toxicity (DLT)
Time Frame: Through study development up to 5 - 6 weeks after the last session of RT/CRT for each enrolled patient
Rate of patients without Dose-Limiting Toxicity (DLT) evaluated from durvalumab administration until 5 - 6 weeks after the last session of RT/CRT.
Secondary Outcomes
- Safety of durvalumab followed by RT/CRT(Through study development up to 17 weeks for each enrolled patient)
- objective response rate(Through study development up to 17 weeks for each enrolled patient)
- Pathologic response rate(Through study development up to 17 weeks for each enrolled patient)
- feasibility of durvalumab followed by RT/CRT(Through study development up to 3 years)