LUX-Lung 8: A randomized, open-label Phase III trial of afatinib versus erlotinib in patients with advanced squamous cell carcinoma of the lung as second-line therapy following first-line platinum-based chemotherapy

Study Status

Closed to Enrollment

Study Description

This clinical trial is for men and women with advanced squamous cell lung cancer whose initial first-line treatment did not work, stopped working or had side effects that were not tolerated.

The purpose of the study to test the effectiveness of an experimental drug called afatinib, compared to erlotinib (an approved lung cancer drug), as the second-line treatment for people with advanced non-small cell squamous cell lung cancer (NSCLC)—squamous cell type.

The results of two clinical trials in lung cancer have shown that afatinib can decrease the size of the tumor and delay the cancer from getting worse. However, it has not been shown that afatinib can result in patients living longer compared to standard treatment.\

Erlotinib (also called Tarceva) is FDA-approved in second and third line settings for locally advanced and/or metastatic NSCLC.

Study participants will be randomly assigned to receive either afatinib or erlotinib. The study is “open label,” which means participants will know which drug they are receiving.

Afatinib and erlotinib are both tablets taken by mouth. Participants will take afatinib or erlotinib daily as long as they are responding to treatment and not experiencing unacceptable side effects.

Disease Status and/or Stage

Previously Treated Advanced Squamous Cell Lung Cancer

Sponsor

Boehringer Ingelheim Pharmaceuticals

Key Eligibility

  • Men and women age 18 and older
  • Advanced stage NSCLC squamous cell lung cancer
  • Completion of at least 4 cycles of platinum-based chemotherapy
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Bryan Schneider, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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