Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGRO5083945
intravenously, until disease progression
DRUGcisplatin
standard treatment, up to 6 cycles
DRUGgemcitabine
standard treatment, up to 6 cycles
DRUGpemetrexed
standard treatment, up to 6 cycles
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/=18 years of age * Advanced (IIIb), metastatic (IV) or recurrent non-small cell lung cancer * At least 1 measurable disease lesion as per RECIST criteria * Confirmed presence of EGFR in tumor tissue * ECOG performance status 0-1 * Adequate hematological, renal and liver function
Exclusion criteria
* Prior chemotherapy or treatment with another systemic anti-cancer agent * Radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief * Symptomatic or active CNS metastases * Recent history of poorly controlled hypertension (systolic \>180mmHg or diastolic \>100mmHg) * Requirement for steroids \> 40 mg prednisolone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 2: Progression-free survival, according to RECIST criteria by CT/MRI | 23 months |
| Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response, according to RECIST criteria by CT/MRI | from response to disease progression |
| Overall response rate (ORR), according to RECIST criteria by CT/MRI | 23 months |
| Overall survival | 23 months |
| Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI | 23 months |
| Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed | multiple sampling cycles 1-6 (18 weeks) |
Countries
Belgium, France, Germany, Italy, Poland, Spain, United Kingdom
Outcome results
None listed