A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Cisplatin; Gemcitabine; Pemetrexed

Criteria

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