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AMG 951

Phase 2

Non-Small Cell Lung Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Jun 14, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment213

FDA Designations

No designations recorded

Clinical trial landscape

AMG 951 · 1 trial · 1 indication

Phase 2 1
NCT00508625A Study of AMG 951 [rhApo2L/TRAIL] in Subjects With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) Treated With Chemotherapy +/- BevacizumabNon-Small Cell Lung Cancer
COMPLETED213 Analytics
PHASE2COMPLETED
A Study of AMG 951 [rhApo2L/TRAIL] in Subjects With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) Treated With Chemotherapy +/- Bevacizumab
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective response rate (CR and PR) by modified RECIST
Until disease progression, drug intolerability or withdrawal of consent

Secondary Endpoints

Progression free survival
Until disease progression, drug intolerability or withdrawal of consent
Time to response
Until disease progression, drug intolerability or withdrawal of consent
Duration of response
Until disease progression, drug intolerability or withdrawal of consent
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
COTHER40 subjects will receive up to 6 cycles of carboplatin (AUC=6.0mg/ml.min) and paclitaxel (200mg/m2) on day 1 of each 21 day cycle plus Bevacizumab (15mg/kg) on day 1 of each 21 day cycle until disease progression, study drug intolerability or withdrawal of consent.
EEXPERIMENTAL40 subjects will receive up to 6 cycles of carboplatin (AUC=6.0mg/ml.min) and paclitaxel (200mg/m2) on day 1 of each 21 day cycle plus Bevacizumab (15mg/kg) on day 1 and AMG 951 (rhApo2L/TRAIL) (20mg/kg) on days 1-2 per 21 day cycle until disease progression, study drug intolerability or withdrawal of consent.
BEXPERIMENTAL40 subjects will receive up to 6 cycles of carboplatin (AUC=6.0mg/ml.min) and paclitaxel (200mg/m2) on day 1 of each 21 day cycle plus AMG 951 (rhApo2L/TRAIL) (8mg/kg) for 5 days per 21 days cycle until disease progression, study drug intolerability or withdrawal of consent.
AOTHER40 subjects will receive up to 6 cycles of Carboplatin (AUC = 6.0mg/ml.min) and Paclitaxel (200mg/m2) only
DEXPERIMENTAL40 subjects will receive up to 6 cycles of carboplatin (AUC=6.0mg/ml.min) and paclitaxel (200mg/m2) on day 1 of each 21 day cycle plus Bevacizumab (15mg/kg) on day 1 and AMG 951 (rhApo2L/TRAIL) (8mg/kg) on days 1-5 per 21 day cycle until disease progression, study drug intolerability or withdrawal of consent.

Interventions

NameTypeDescription
AMG 951 (rhApo2L/TRAIL)DRUGAMG 951 is recombinant human Apo2Ligand/Tumor necrosis factor related apoptosis inducing ligand (rhApo2L/TRAIL) that triggers apoptosis through activation of death receptor 4 (DR4) and death receptor 5 (DR5).
BevacizumabDRUGBevacizumab is a recombinant humanized version of a murine antibody to vascular endothelial growth factor (VEGF).
CarboplatinDRUGStandard platinum based chemotherapy
PaclitaxelDRUGStandard taxane chemotherapy
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC). Mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible. Cytologic or histologic elements can be established on me...

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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about AMG 951

What is AMG 951 used for?

AMG 951 is an investigational small molecule being studied for the treatment of non-small cell lung cancer (NSCLC). It is being developed by Amgen Inc. and is currently in Phase 2 clinical development. The drug is not approved and remains under investigation for this indication.

Who makes AMG 951?

AMG 951 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AMGN. The drug is an investigational small molecule in Phase 2 clinical development for non-small cell lung cancer.

What phase is AMG 951 in?

AMG 951 is in Phase 2 clinical development. It is an investigational small molecule being studied for non-small cell lung cancer. The drug is not approved and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is AMG 951 in?

AMG 951 has one completed Phase 2 clinical trial, NCT00508625, which enrolled 213 participants with previously untreated non-small cell lung cancer. The study evaluated AMG 951 in combination with chemotherapy, with or without bevacizumab. The trial was controlled and randomized but not double-blind.

Is AMG 951 the same as rhApo2L/TRAIL?

AMG 951 is also known as rhApo2L/TRAIL. In clinical trial NCT00508625, the drug is referred to as AMG 951 [rhApo2L/TRAIL]. This alternative name may appear in scientific literature and trial registries.