Clinical trial NCT01561456 (phase 2, status: completed)
Conditions: non-small-cell lung cancer, squamous cell carcinoma, adenocarcinoma of the lung
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C44.520, C44.92, C44.02, C44.321, C44.521, C44.82, C44.42, D02.20, D02.21, D02.22
Drugs: axl1717, docetaxel
SMILES: COC1=CC(=CC(OC)=C1OC)[C@H]1[C@H]2[C@H](COC2=O)[C@@H](O)C2=CC3=C(OCO3)C=C12, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        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