At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 enrolled
Drug / intervention
durvalumabdrug
Likely dose
Durvalumab dose not specified in protocol excerptAI-extracted
Key inclusion· 7
- ✓Stage IIIB or IV NSCLC confirmed histologically or cytologically
- ✓Measurable disease required
- ✓No prior systemic therapy for stage IV NSCLC
- ✓ECOG performance status of 2
Key exclusion· 8
- ✕Prior PD-1 or PD-L1 inhibitor therapy
- ✕EGFR sensitizing mutations or ALK/ROS1 rearrangements
- ✕Symptomatic or uncontrolled brain metastases requiring treatment
- ✕Active or prior autoimmune disease within 2 years (except vitiligo, Grave's disease, or psoriasis not requiring systemic treatment)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Clinical Trial Evaluating the Safety and Efficacy of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
Academic Thoracic Oncology Medical Investigators Consortium·interventional·Posted Aug 25, 2016·Updated Jan 5, 2024
In Brief
A Phase 2 clinical trial evaluating durvalumab for Non-Small Cell Lung Cancer NSCLC. Completed, enrolled 47 participants across 2 sites.
Detailed Summary
This is a single-arm phase II clinical trial evaluating the safety and efficacy of the PD-L1 inhibitor durvalumab as first-line therapy in 47 patients with advanced NSCLC and ECOG Performance Status 2 (PS2).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer NSCLC
CountriesUnited States
CollaboratorsAstraZeneca
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartApr 2017
Primary CompletionJun 2022
TodayJul 2026
First PostedAug 25, 2016
Enrollment StartApr 4, 2017
Primary CompletionJun 4, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.9 years ago
Interventions
durvalumabdrug
A human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody directed against programmed cell death ligand 1 (PD-L1)