CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Afatinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03157089
NCT03157089Phase 2Completed

LUX-Lung IO: A Phase II, Open Label, Non-randomised Study of Afatinib in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Lung

Boehringer Ingelheim·interventional·Posted May 17, 2017·Updated Feb 23, 2021

In Brief

A Phase 2 clinical trial evaluating Afatinib and pembrolizumab for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 24 participants across 13 sites in 5 countries.

Detailed Summary

The main objective is to assess the efficacy of afatinib in combination with pembrolizumab, as measured by objective response (OR) in patients with locally advanced or metastatic squamous NSCLC who progressed during or after first line platinum-based treatment. The secondary objectives are to confirm the RP2D, assess the safety profile, and the secondary measures of clinical efficacy including disease control (DC), duration of objective response (DoR), progression-free survival (PFS), overall survival (OS), and tumour shrinkage.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, South Korea, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 17, 2017
Enrollment StartNov 2, 2017
Primary CompletionJan 13, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.1 years ago

Interventions

Afatinibdrug

Film-coated tablet

pembrolizumabdrug

Solution for infusion