CI

At a glance

ClinicalIndex Comparison Record
Phase 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.

Search/NCT02879617
NCT02879617Phase 2Completed

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--
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
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)