This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
intravenously, until disease progression
standard treatment, up to 6 cycles
standard treatment, up to 6 cycles
standard treatment, up to 6 cycles
Unnamed facility
Charleroi, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Liège, Belgium
Unnamed facility
Caen, France
Unnamed facility
Marseille, France
Unnamed facility
Saint-Herblain, France
Unnamed facility
Toulouse, France
Unnamed facility
Bad Berka, Germany
Unnamed facility
Cologne, Germany
Unnamed facility
Gauting, Germany
...and 22 more locations
Part 2: Progression-free survival, according to RECIST criteria by CT/MRI
Time frame: 23 months
Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)
Time frame: 6 months
Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed
Time frame: multiple sampling cycles 1-6 (18 weeks)
Duration of response, according to RECIST criteria by CT/MRI
Time frame: from response to disease progression
Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI
Time frame: 23 months
Overall survival
Time frame: 23 months
Overall response rate (ORR), according to RECIST criteria by CT/MRI
Time frame: 23 months
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