CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
Pembrolizumabbiological
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Chinese race (Chinese descent born in China) with Chinese home address
  • ✓Life expectancy of at least 3 months
  • ✓Histologically- or cytologically-confirmed advanced unresectable NSCLC with measurable disease by RECIST 1.1
  • ✓Failed standard anti-cancer therapies or intolerant to them, or deemed ineligible for standard therapy on medical grounds
Key exclusion· 13
  • ✕Chemotherapy, radioactive, or biological cancer therapy within 4 weeks prior to first dose, unless recovered to CTCAE Grade 1 or better
  • ✕Concurrent participation in another investigational drug/device study within 4 weeks prior to first dose
  • ✕Requirement for other antineoplastic therapy while on study, including maintenance therapy
  • ✕Chronic systemic steroid therapy or other immunosuppressive medication

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

Search/NCT02835690
NCT02835690Phase 1Completed
CompareCT.gov

An Open-label, Randomized Phase I Study Investigating Safety, Tolerability, Pharmacokinetics, and Efficacy of Pembrolizumab (MK-3475) in Chinese Subjects With Non-Small-Cell Lung Cancer

Merck Sharp & Dohme LLC·interventional·Posted Jul 18, 2016·Updated Oct 26, 2022

In Brief

A Phase 1 clinical trial evaluating Pembrolizumab for Non-Small-Cell Lung Cancer. Completed, enrolled 44 participants.

Detailed Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of three doses of pembrolizumab (MK-3475) in adult Chinese participants with locally advanced or metastatic non-small-cell lung cancer (NSCLC). Cycle 1 is 28 days long; subsequent cycles are 21 days long.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small-Cell Lung Cancer
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 18, 2016
Enrollment StartAug 4, 2016
Primary CompletionSep 19, 2017
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.0 years ago

Interventions

Pembrolizumabbiological

IV infusion