This open-label, multicenter, non-randomized, dose-escalating phase Ib study with an expansion cohort will determine the recommended Phase II dose and schedule to investigate safety, tolerability, and activity of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel in patients with advanced or recurrent non-small cell lung cancer of squamous histology who have not received prior chemotherapy for the metastatic disease. Cohorts of patients will receive escalating doses of RO5083945 in combination with up to 6 cycles of cisplatin and gemcitabine or carboplatin and paclitaxel. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
multiple ascending doses
up to 6 cycles
up to 6 cycles
up to 6 cycles
up to 6 cycles
Maximum tolerated dose in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Time frame: approximately 1.5 years
Recommended phase II dose (RP2D) of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Time frame: approximately 1.5 years
Safety: Incidence of adverse events
Time frame: approximately 1.5 years
Pharmacokinetics: Serum concentrations of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Time frame: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of cisplatin
Time frame: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of gemcitabine
Time frame: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of carboplatin
Time frame: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of paclitaxel
Time frame: up to 18 weeks
Preliminary evidence of antitumor activity: Objective response rate (complete response, partial response and stable disease)
Time frame: approximately 1.5 years
Duration of response
Time frame: approximately 1.5 years
Biomarker assessments : Immune effector cells/EGFR markers
Time frame: up to 18 weeks
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