Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-03 @ 11:05 PM
Study NCT ID:
NCT03620669
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2018-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1st Line Durvalumab in PS 2 NSCLC Patients
Sponsor:
Swiss Cancer Institute
Organization:
Study Overview
Official Title:
First Line Durvalumab in Patients With PD-L1 Positive, Advanced NSCLC With Performance Status 2 Unsuitable for Combination Chemotherapy. A Multicenter, Single-arm Phase II Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
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:
None
Brief Summary:
The aim of the trial is to assess efficacy and safety of the treatment with durvalumab in PS 2 patients with treatment-naïve, locally advanced or metastatic, PD-L1 positive NSCLC who are considered unsuitable for combination platinum-containing therapy.
Detailed Description:
Lung cancer is the leading cause of cancer deaths. An estimated 30 to 40% of patients diagnosed with NSCLC have a poor Performance status (PS) defined as a score of 2 or higher on the ECOG scale. PS 2 patients are often underrepresented in clinical trials despite representing a very frequent and important subgroup.
Platinum-based (preferably carboplatin) doublets should be considered as standard of care in eligible PS 2 patients. However the toxicity profile of platinum-based doublets remains a concern. Single-agent chemotherapy represents an alternative treatment option for the PS 2 patients considered unsuitable for platinum doublet chemotherapy but its efficacy is limited and the outcome poor.
Given the superiority of the anti-PD-1 antibody pembrolizumab versus standard chemotherapy as first line therapy in a PD-L1 positive NSCLC population, it now became the standard treatment. The PS of patients enrolled in these trials were PS 0 or 1, making the benefit of PD-L1 antibodies in PS 2 patients unclear. A retrospective real-life data analysis of nivolumab in metastatic NSCLC revealed similar treatment-related AE between patients with a PS of 0 or 1 with those having a PS of 2, confirming good treatment tolerability in poor PS patients.
The overall favorable toxicity profile of durvalumab and the absence of robust efficacy data of checkpoint inhibitors in first line treatment of patients with PD-L1 positive NSCLC with a PS of 2, encourage to investigate its activity in this cohort of patients when considered unsuitable for platinum doublet chemotherapy.
Finally, this trial aims to prolong overall survival by treating this cohort of frail patients with durvalumab, compared to historical controls, treated with single agent chemotherapy.
Platinum-based (preferably carboplatin) doublets should be considered as standard of care in eligible PS 2 patients. However the toxicity profile of platinum-based doublets remains a concern. Single-agent chemotherapy represents an alternative treatment option for the PS 2 patients considered unsuitable for platinum doublet chemotherapy but its efficacy is limited and the outcome poor.
Given the superiority of the anti-PD-1 antibody pembrolizumab versus standard chemotherapy as first line therapy in a PD-L1 positive NSCLC population, it now became the standard treatment. The PS of patients enrolled in these trials were PS 0 or 1, making the benefit of PD-L1 antibodies in PS 2 patients unclear. A retrospective real-life data analysis of nivolumab in metastatic NSCLC revealed similar treatment-related AE between patients with a PS of 0 or 1 with those having a PS of 2, confirming good treatment tolerability in poor PS patients.
The overall favorable toxicity profile of durvalumab and the absence of robust efficacy data of checkpoint inhibitors in first line treatment of patients with PD-L1 positive NSCLC with a PS of 2, encourage to investigate its activity in this cohort of patients when considered unsuitable for platinum doublet chemotherapy.
Finally, this trial aims to prolong overall survival by treating this cohort of frail patients with durvalumab, compared to historical controls, treated with single agent chemotherapy.
Study Oversight
Has Oversight DMC:
True
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?: