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Pemetrexed

Phase 4FDA approved

Non Small Cell Lung Cancer | Small molecule | Oncology |Eli Lilly and Company|Trials Updated: Oct 20, 2009

Pemetrexed development status

FDA approval on record Aug 19, 2004
Approval holderLilly
ApplicationNDA021677
Highest phase Phase 4 (NCT00380718)
Phase scored for LLYPhase 2
Registered trials 356+ across 97 sponsors since Apr 2002

Pemetrexed target and mechanism

ModalitySmall molecule

Also known as LY231514, Alimta

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials8
Total Enrollment69

FDA Designations

No designations recorded

Pemetrexed clinical trials

Pemetrexed · 8 trials · 8 indications

Phase 2 5Phase 1 3
NCT00370292Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)Non Small Cell Lung Cancer
COMPLETED19 Analytics
NCT00051493ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.Carcinoma, Non-Small-Cell Lung
COMPLETED50 Analytics
NCT00034593A Phase 2 Trial of ALIMTA (Pemetrexed) Plus Gemcitabine in Locally Advanced or Metastatic Transitional Cell Carcinoma of the UrotheliumUrologic Neoplasms
COMPLETED- Analytics
NCT00034619A Phase 2 Trial of ALIMTA (LY231514, Pemetrexed) Plus Oxaliplatin Administered Every 21 Days for First-Line Treatment of Patients With Advanced Colorectal Cancer.Colorectal Cancer
COMPLETED- Analytics
NCT00051506ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.Lung Neoplasms
COMPLETED- Analytics
PHASE2COMPLETED
Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung CancerUnlock trial analytics
PHASE2COMPLETED
ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.
Carcinoma, Non-Small-Cell LungUnlock trial analytics
PHASE2COMPLETED
A Phase 2 Trial of ALIMTA (Pemetrexed) Plus Gemcitabine in Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
Urologic NeoplasmsUnlock trial analytics
PHASE2COMPLETED
A Phase 2 Trial of ALIMTA (LY231514, Pemetrexed) Plus Oxaliplatin Administered Every 21 Days for First-Line Treatment of Patients With Advanced Colorectal Cancer.
Colorectal CancerUnlock trial analytics
PHASE2COMPLETED
ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.
Lung NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)

dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).

Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)

dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).

Secondary Endpoints

Best Objective Tumor Response
baseline to measured response (every 14 days for 6 cycles)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pemetrexed - Before Protocol AmendmentEXPERIMENTAL -
Pemetrexed - After Protocol AmendmentEXPERIMENTAL -

Interventions

NameTypeDescription
Pemetrexed - Before Protocol AmendmentDRUG500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue
Pemetrexed - After Protocol AmendmentDRUG500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
ALIMTADRUG -
CarboplatinDRUG -
gemcitabineDRUG -
OxaliplatinDRUG -
cisplatinDRUG -
folic acidDRUG -
multi-vitaminsDRUG -
irinotecanDRUG -
ALIMTA plus EpirubicinDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria * Histologically or cytologically proven IIIB and IV NSCLC. * No symptomatic uncontrolled brain metastasis * Not suitable for platinum containing regimens if chemo-naive * Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale. * Creatin...

Countries:ItalyUnited StatesFinlandFranceGermanyArgentinaBelgiumBrazilMexicoPortugal
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Competitive Landscape -Non-Small Cell Lung Cancer 544 trials (matched to "Non Small Cell Lung Cancer")

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.ABBV12PHASE3Telisotuzumab vedotin, ABBV-1480, Livmoniplimab, Budigalimab, Telisotuzumab Adizutecan
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
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS11PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, KFA115
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
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 Pemetrexed

What is Pemetrexed- Before Protocol Amendment used for?

Pemetrexed- Before Protocol Amendment is an investigational small molecule studied in non-small cell lung cancer. It was evaluated in patients with locally advanced or metastatic NSCLC. The Phase 2 study enrolled adults aged 18 years and older in Italy. It is not described as an approved product.

Who is developing Pemetrexed- Before Protocol Amendment?

Pemetrexed- Before Protocol Amendment is developed by Eli Lilly and Company, which trades under the ticker LLY. Eli Lilly sponsored the Phase 2 dosage schedule study of pemetrexed monochemotherapy in locally advanced or metastatic non-small cell lung cancer. The company is the named developer of this asset.

What phase is Pemetrexed- Before Protocol Amendment in?

Pemetrexed- Before Protocol Amendment is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The study enrolled 19 participants and has finished. Because the program remains in clinical development, it is investigational rather than an approved therapy.

What clinical trials is Pemetrexed- Before Protocol Amendment in?

Pemetrexed- Before Protocol Amendment was studied in trial NCT00370292, titled Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). The Phase 2 trial was completed, enrolled 19 participants, and was conducted in Italy. It was controlled but not randomized or double blinded.

Is Pemetrexed- Before Protocol Amendment the same as Pemetrexed?

Yes. Pemetrexed- Before Protocol Amendment is also known as Pemetrexed - Before Protocol Amendment. The two names refer to the same asset, a small molecule studied in non-small cell lung cancer. Searches using either name point to the same Phase 2 program developed by Eli Lilly and Company.

What kind of study design did Pemetrexed- Before Protocol Amendment use?

The Phase 2 trial of Pemetrexed- Before Protocol Amendment used a controlled design without randomization or double blinding. It enrolled 19 adults aged 18 years and older with locally advanced or metastatic non-small cell lung cancer in Italy. Participants were not selected by biomarker, and healthy volunteers were not included.