A Two-Part, Open Label Phase II Trial: Part One, Dose Escalation Safety; Part Two, Randomized/Comparing CDP791 Plus Carboplatin/Paclitaxel With Carboplatin/Paclitaxel Alone in Subjects With Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
This is a two part study to investigate the safety and anti-tumour effects of standard
chemotherapy, plus an investigational drug (CDP791), in patients with advanced non small
cell lung cancer.
In part one, patients receive carboplatin and paclitaxel chemotherapy together with one of 2
doses of CDP791. The main aim of this part is to investigate safety and tolerability of
carboplatin/paclitaxel plus CDP791.
If part one confirms that the combination of drugs is safe and well tolerated, 156 patients
will enter part 2. They will be randomized to receive either carboplatin/paclitaxel (C/P)
alone, or C/P plus one of 2 doses of CDP791. The main aim of this part of the study is to
compare the anti-tumor effects of CDP791 plus C/T with those of C/T alone. Participants
will receive up to six cycles of chemotherapy with or without CDP791. Those whose disease
stabilizes, or responds, will be eligible to continue to receive CDP791. Participants in the
C/T alone arm whose disease progresses will be eligible to receive CDP791 monotherapy.
Participants will be followed up longterm, so that survival can be measured.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumour response rate at 18 weeks.
UCB Clinical Trial Call Center
+1 877 822 9493
Hungary: National Institute of Pharmacy