LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung
Intervention: afatinib; erlotinib
Intervention description: Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.; erlotinib taken once daily
Intervention MeSH terms: Erlotinib Hydrochloride; Afatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 795.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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 International Conference on
             Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines.

        Exclusion criteria:

          1. Prior treatment with Epidermal Growth Factor Receptor (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.