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

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC Read More

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.