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RO5490258

Phase 2

Non-Squamous Non-Small Cell Lung Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Sep 23, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment259

FDA Designations

No designations recorded

Clinical trial landscape

RO5490258 · 1 trial · 1 indication

Phase 2 1
NCT01496742A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung CancerNon-Squamous Non-Small Cell Lung Cancer
COMPLETED259 Analytics
PHASE2COMPLETED
A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer
Non-Squamous Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival (tumor assessments according to RECIST criteria)
up to approximately 23 months
Progression-free survival: Subgroup of patients with Met diagnostic positive tumors
up to approximately 23 months

Secondary Endpoints

Overall survival
up to approximately 23 months
Overall response rate (tumor assessments according to RECIST criteria)
up to approximately 23 months
Duration of response (time from first documented objective response to disease progression)
up to approximately 23 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bevacizumab+MetMAbEXPERIMENTAL -
Bevacizumab+PlaceboACTIVE_COMPARATOR -
Pemetrexed+MetMAbEXPERIMENTAL -
Pemetrexed+PlaceboACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGMatching RO5490258 (MetMAb) placebo iv, Day 1 of each 21-day cycle
RO5490258DRUG15 mg/kg iv, Day 1 of each 21-day cycle
bevacizumab [Avastin]DRUG15 mg/kg iv, Day 1 of each 21-day cycle
cisplatin/carboplatinDRUGstandard dose iv, Day 1 of each 21-day cycle, 4 cycles
paclitaxelDRUG200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
pemetrexedDRUG500 mg/m2, Day 1 of each 21-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites87

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous non-small cell lung cancer (NSCLC) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * For patients who received prior adjuvant chemotherapy...

Countries:United StatesArgentinaFranceGermanyIsraelItalyLatviaMalaysiaMexicoPhilippinesSpainTaiwanUnited Kingdom
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Frequently asked questions about RO5490258

What is RO5490258 used for in Non-Squamous Non-Small Cell Lung Cancer?

RO5490258 is an investigational small molecule being studied for the treatment of Non-Squamous Non-Small Cell Lung Cancer. It is currently in Phase 2 clinical development and is not approved for use. The drug is being evaluated in combination with other therapies to assess its safety and efficacy in this patient population.

Who is developing RO5490258?

RO5490258 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research to evaluate the drug's potential in treating Non-Squamous Non-Small Cell Lung Cancer. As an investigational agent, it is not yet available commercially.

What phase is RO5490258 in?

RO5490258 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 study is designed to evaluate the drug's efficacy and safety in patients with Non-Squamous Non-Small Cell Lung Cancer.

What clinical trials is RO5490258 in?

RO5490258 is being studied in a completed Phase 2 clinical trial with the identifier NCT01496742. The trial enrolled 259 participants and evaluated the drug in combination with bevacizumab plus platinum and paclitaxel, or with pemetrexed plus platinum, in patients with Non-Squamous Non-Small Cell Lung Cancer.

Is RO5490258 the same as onartuzumab?

RO5490258 is also known as onartuzumab, and the two names refer to the same investigational drug. In clinical trials, it is studied under the name onartuzumab, and it is being developed by Roche for the treatment of Non-Squamous Non-Small Cell Lung Cancer.

What is the mechanism of action of RO5490258?

RO5490258 is a small molecule therapeutic agent. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its potential role in treating Non-Squamous Non-Small Cell Lung Cancer, but its exact mechanism of action remains under study.