CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Pembrolizumab +1 morebiological
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically or cytologically confirmed NSCLC with at least one measurable lesion per modified RECIST 1.1
  • ✓EGFR mutation (sensitizing or non-sensitizing)
  • ✓PD-L1 positive tumor (IHC 22C3 pharmDx) from newly obtained biopsy
  • ✓Life expectancy of at least 3 months
Key exclusion· 7
  • ✕Prior therapy with EGFR tyrosine kinase inhibitor (erlotinib, gefitinib, afatinib, rociletinib, AZD9291)
  • ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 therapy
  • ✕Active or untreated CNS metastases
  • ✕Active autoimmune disease or history requiring systemic steroids/immunosuppressants

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02879994
NCT02879994Phase 2Completed
CompareCT.gov

A Phase II Study of Pembrolizumab in EGFR Mutant, Tyrosine Kinase Inhibitor Naïve Treatment Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Jonsson Comprehensive Cancer Center·interventional·Posted Aug 26, 2016·Updated Jul 14, 2021

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis and Pembrolizumab for Stage IIIA Non-Small Cell Lung Cancer and 2 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed Summary

This phase II trial studies how well pembrolizumab works in treating patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer that have not received prior tyrosine kinase inhibitor therapy and has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may block growth in different ways by targeting certain cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 26, 2016
Enrollment StartSep 15, 2016
Primary CompletionNov 30, 2017
Study CompletionJan 3, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.8 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Pembrolizumabbiological

Given IV