Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 2:37 AM
Study NCT ID:
NCT05267392
Status:
UNKNOWN
Last Update Posted:
2022-03-04
First Post:
2021-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEAR
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-002884-90 | EUDRACT_NUMBER | None | View |