NCT01121393

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)

LUX-Lung 6: A Randomized, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 364 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of BIBW 2992 compared to standard first-line chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation

Conditions

• Carcinoma, Non-Small-Cell Lung
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine+Cisplatin	Gemcitabine d1,8, Cisplatin d1, 21 days as a course, up to 6 courses.
DRUG	BIBW 2992	starting dose is 40 mg, in the event of no or minimal drug-related adverse events after one course, the dose will be increased to 50mg. in the event of certain drug related Adverse Event (AE), dose reduction will be increments of 10 mg, with the lowest dose being 20mg.

Timeline

• Start date: 2010-04-19
• Primary completion: 2017-11-23
• Completion: 2017-11-26
• First posted: 2010-05-12
• Last updated: 2018-12-14
• Results posted: 2015-01-26

Locations

36 sites across 3 countries: China, South Korea, Thailand