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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Multicenter, Open-label Phase Ib/II Study of RO5083945 in Combination With Cisplatin and Gemcitabine/Pemetrexed Versus Cisplatin and Gemcitabine/Pemetrexed in Patients With Advanced or Recurrent Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185847
• Other study ID #: BP22349
• Secondary ID: 2010-018945-72
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2010
• Last updated: December 31, 2015
• Start date: November 2010
• Est. completion date: September 2012

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• RO5083945
intravenously, until disease progression
• cisplatin
standard treatment, up to 6 cycles
• gemcitabine
standard treatment, up to 6 cycles
• pemetrexed
standard treatment, up to 6 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 2: Progression-free survival, according to RECIST criteria by CT/MRI		23 months	No
Primary	Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)		6 months	No
Secondary	Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed		multiple sampling cycles 1-6 (18 weeks)	No
Secondary	Duration of response, according to RECIST criteria by CT/MRI		from response to disease progression	No
Secondary	Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI		23 months	No
Secondary	Overall survival		23 months	No
Secondary	Overall response rate (ORR), according to RECIST criteria by CT/MRI		23 months	No