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AMG 951

Phase 2

Non-Small Cell Lung Cancer | Small molecule | Oncology |Amgen Inc.|Trials 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

AMG 951 clinical trials

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 541 trials

Top 20 of 90 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK37PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
Revolution Medicines, Inc.RVMD9PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV12PHASE3ABBV-1480, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab, Budigalimab
AstraZeneca PLCAZN68PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Gilead Sciences, Inc.GILD7PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant, TUB-040- Dose escalation
Bristol-Myers Squibb CompanyBMY24PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
Johnson & JohnsonJNJ19PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Pfizer Inc.PFE20PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS12PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, trametinib
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN7PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
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Frequently asked questions about AMG 951

What is AMG 951 used for?

AMG 951 was studied for the treatment of non-small cell lung cancer (NSCLC). Specifically, it was evaluated in previously untreated patients receiving chemotherapy with or without bevacizumab. AMG 951 is an investigational agent and is not approved for any indication.

Who is developing AMG 951?

AMG 951 is being developed by Amgen Inc. (ticker: AMGN). Amgen sponsored the clinical trial evaluating AMG 951 in non-small cell lung cancer.

What phase is AMG 951 in?

AMG 951 is in Phase 2 clinical development. It has completed one Phase 2 trial in non-small cell lung cancer. No Phase 3 trials have been initiated.

What clinical trials is AMG 951 in?

AMG 951 has been studied in one completed Phase 2 trial, NCT00508625, titled "A Study of AMG 951 [rhApo2L/TRAIL] in Subjects With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) Treated With Chemotherapy +/- Bevacizumab." The trial enrolled 213 patients and was randomized and controlled.