Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung

This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring non-small-cell lung cancer, squamous cell carcinoma, adenocarcinoma of the lung, IGF-1 inhibitor, docetaxel, AXL1717, NSCLC, SCC, AC Read More

Inclusion Criteria:

• informed of the study and have provided written informed consent
• At least 18 years of age
• Histologically confirmed diagnosis of locally advanced, or metastatic squamous cell carcinoma or adenocarcinoma histological subtypes of non-small-cell lung cancer (stage IIIB or IV)
• For patients with squamous cell histology: previously treated with first-line chemotherapy and has had disease progression during or after first-line therapy.
• For patients with adenocarcinoma histology: previously treated with one or two lines of chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy ≥ 3 months
• Measurable disease by RECIST 1.1 criteria
• Hematology values: blood leukocyte count ≥ 3.0 x 109/L, blood absolute neutrophil count ≥ 1.5 x 109/L, blood platelet count ≥ 100 x109/L, hemoglobin ≥ 100 g/L (transfusions are allowed)
• Clinical chemistry values: plasma total bilirubin level ≤ upper limit of the "normal" range (ULN; i.e. reference), plasma AST or ALT ≤ 1.5 x ULN (≤ 5 times if liver metastases have been documented) and plasma creatinine ≤ 2.0 x ULN
• 12-lead ECG with normal tracings

Exclusion Criteria:

• Mixed histology of squamous and non-squamous NSCLC
• Ongoing infection or other major recent or ongoing disease that, according to the Investigator, poses an unacceptable risk to the patient
• Known primary or secondary central nervous system malignancy.
• Active or previously treated carcinomatous meningitis

• Truly non-measurable disease by RECIST 1.1 criteria, such as patients with one or more of the following without any RECIST measurable disease:

  • Bone lesions
  • Ascites
  • Pleural or pericardial effusion
  • Lymphangitis cutis or pulmonis
  • Cystic lesions
• Grade 3 or higher constipation within the past 28 days or grade 2 constipation within the past 14 days before randomization.
• Active hepatitis B, active hepatitis C, or known HIV infection
• Coexisting uncontrolled medical condition, including active cardiac disease (such as unstable angina, myocardial infarction within 6 months, or New York Heart Association Class III/IV congestive heart failure), and significant dementia
• Hepatic impairment as indicated by abnormalities of transaminases (AST and/or ALT > 1.5 × ULN or AST and/or ALT > 5 times ULN if liver metastases have been documented) and/or increased alkaline phosphatase (> 2.5 × ULN) considered as a result of hepatic impairment (and not from bone disease)
• History of cancer that has required treatment or been active within the past 5 years, other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ
• Major surgical procedure within 4 weeks prior to randomization
• More than one prior anti-tumor systemic therapy for advanced squamous cell NSCLC, and more than two prior lines of chemotherapy for advanced adenocarcinoma NSCLC
• Previous use of docetaxel in any line of therapy
• Women of child bearing potential (WOCBP) who do not consent to using acceptable methods of contraception
• Women who are breast-feeding or have a positive pregnancy test at screening
• Current participation in any other investigational clinical trial or any administration of an investigational agent within 4 weeks of study drug administration
• ECOG performance status > 2
• Life expectancy < 3 months
• Known or suspected hypersensitivity to AXL1717 or docetaxel or to drugs formulated with polysorbate 80
• Lack of suitability for participation in the trial, for any reason, as judged by the Investigator