NCT03157089

Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Afatinib	Film-coated tablet
DRUG	pembrolizumab	Solution for infusion

Timeline

• Start date: 2017-11-02
• Primary completion: 2020-01-13
• Completion: 2020-01-13
• First posted: 2017-05-17
• Last updated: 2021-02-23
• Results posted: 2021-02-23

Locations

13 sites across 5 countries: United States, France, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study