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

Phase 2

Completed

• Conditions: Non-Squamous Non-Small Cell Lung Cancer
• Interventions: Drug: RO5083945; Drug: cisplatin; Drug: pemetrexed; Drug: gemcitabine

• Registration Number: NCT01185847
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-20
• Study Start: 2010-11
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-31
• Last Update Posted: 2016-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A squamous	RO5083945	-
A non-squamous	RO5083945	-
A squamous	cisplatin	-
A non-squamous	pemetrexed	-
A non-squamous	cisplatin	-
A squamous	gemcitabine	-
B non-squamous	cisplatin	-
B squamous	cisplatin	-
B non-squamous	pemetrexed	-
B squamous	gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)	6 months
Part 2: Progression-free survival, according to RECIST criteria by CT/MRI	23 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed	multiple sampling cycles 1-6 (18 weeks)
Duration of response, according to RECIST criteria by CT/MRI	from response to disease progression
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
Overall response rate (ORR), according to RECIST criteria by CT/MRI	23 months