Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments afatinib, erlotinib
Phase phase 3
Targets EGFR, HER2, HER4
Sponsor Boehringer Ingelheim
Start date March 2012
End date October 2013
Trial size 795 participants
Trial identifier NCT01523587, 1200.125, 2011-002380-24

Summary

This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive afatinib tablets once daily
afatinib
Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.
(Active Comparator)
Patients receive erlotinib tablets once daily
erlotinib
erlotinib taken once daily

Primary Outcomes

Measure
Progression-free Survival, Based on Central Independent Review as Determined by RECIST 1.1
time frame: First treatment administration up until cut off date of 7th October 2013 (up to 78 weeks).

Secondary Outcomes

Measure
Overall Survival
time frame: From randomisation until 632 deaths
Objective Response According to RECIST 1.1
time frame: First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).
Disease Control According to RECIST 1.1
time frame: First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).
Tumour Shrinkage
time frame: First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).
Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire
time frame: First treatment administration up to 28 days after the last intake of study medication.
Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.
time frame: First treatment administration up to 28 days after the last intake of study medication.
Change in Score Over Time in Coughing,Dyspnoea and Pain
time frame: First treatment administration up to 28 days after last intake of study medication

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: 1. Diagnosis of advanced stage NSCLC squamous histology. 2. Platinum-based doublet chemotherapy as 1st line treatment of Stage IIIB/IV NSCLC. 3. Eligible to receive 2nd line therapy in the opinion of the investigator. 4. Measurable disease according to RECIST 1.1. 5. Adequate Performance Status. 6. Availability of tumour tissue material for correlative studies. Archived tumour tissue is acceptable. 7. Adequate organ function. 8. Age = 18 years and above. 9. Written informed consent that is consistent with ICH-GCP guidelines. Exclusion criteria: 1. Prior treatment with EGFR directed small molecules or antibodies. 2. Radiotherapy within 4 weeks prior to randomization. 3. Active brain metastases . 4. Any other current malignancy or malignancy diagnosed within the past three (3) years (other than basal-cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer). 5. Known pre-existing interstitial lung disease. 6. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom 7. Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug. 8. Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended. 9. Female patients of childbearing potential (see Section 4.2.3.3) who: 1. are nursing or 2. are pregnant or 3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and/or do not agree to submit to pregnancy testing required by this protocol. 10. Active hepatitis B infection (defined as presence of Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier. 11. Known or suspected active drug or alcohol abuse in the opinion of the investigator. 12. Any contraindications for therapy with afatinib or erlotinib. 13. Known hypersensitivity to erlotinib, afatinib or the excipients of any of the trial drugs. 14. Major surgery within 4 weeks of starting study treatment. 15. Prior participation in an afatinib clinical study, even if not assigned to afatinib. 16. Use of any investigational drug within 4 weeks of randomisation (unless a longer time period is required by local regulations or by the guidelines for the investigational product). 17. Patients without Progression of their lung cancer.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.