A Study of the IGF-1R Inhibitor AXL1717 in Combination With Gemcitabine HCL and Carboplatin to Treat Non-small-cell Lung Cancer (NSCLC)

Inclusion Criteria:

1. At least 18 years of age.
2. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic squamous non-small-cell lung cancer (stage IIIB or IV) and scheduled for treatment with cytotoxic chemotherapy (Gemcitabine HCL/Carboplatin)
3. Preserved major organ functions, i.e:

   * B-Leukocyte count ≥ 3.0 x 109/L
   * B-Neutrophil count ≥ 1.5 x 109/L
   * B-Platelet count ≥ 75 x109/L
   * B-Haemoglobin ≥ 100 g/L (transfusions are allowed)
   * P-Total bilirubin level ≤ 1.5 times the upper institutional limit of the "normal" (i.e. reference)range
   * P-ASAT or P-ALAT ≤ 2.5 times upper institutional limit of the "normal" range, ≤5 times if liver metastases have been documented
   * P-Creatinine ≤ 1.5 times upper institutional limit of the "normal" range
   * 12-lead ECG with normal tracings; or clinically nonsignificant changes that did not require medical intervention
4. Signed written informed consent.

Exclusion Criteria:

* The presence of any of the following criteria will exclude the patient from participating in the study:

  * Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient
  * Grade 3 or higher constipation within the past 28 days or grade 2 constipation within the past 14 days before randomization. (Patients with grade 2 constipation within the past 14 days could be re-screened if constipation decreases to ≤ grade 1 with optimal management of constipation.)
  * Known malignancy in Central Nervous System (CNS)
  * Disease and dementia and neuropathy grade more than 1
  * Other active malignancy during the previous 3 years
  * Major surgical procedure within 4 weeks
  * Prior anti-tumor therapy apart from radiation therapy
  * Women Of Child Bearing Potential (WOCBP) - For purposes of this study, WOCBP include any female who has experienced menarche and who is not postmenopausal. Post menopause is defined as: Amenorrhea ≥ 12 consecutive months without another cause
  * Pregnancy or lactation
  * Current participation in any other interventional clinical trial
  * Performance status \> ECOG 2 after optimization of analgesics
  * Life expectancy less than 3 months
  * Contraindications to the investigational product, e.g. known or suspected hypersensitivity.
  * Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.