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Alimta or Taxotere

Phase 3

Non-Small Cell Lung Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Feb 23, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment424

FDA Designations

No designations recorded

Clinical trial landscape

Alimta or Taxotere · 1 trial · 1 indication

Phase 3 1
NCT00556322A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung Cancer
COMPLETED424 Analytics
PHASE3COMPLETED
A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months

Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death.

Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months

OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.

Probable Percentage of Participants Remaining Alive at 1 Year
1 Year

OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.

Secondary Endpoints

Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
Duration of OS in EGFR Positive and Negative Population
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population
1 Year
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Alimta or TaxotereDRUG500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)
erlotinib [Tarceva]DRUG150mg po daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites123

Inclusion Criteria: * adult patients \>=18 years of age; * histologically documented, locally advanced or recurrent or metastatic NSCLC; * measurable disease; * disease progression during 1-4 cycles of platinum-based chemotherapy. Exclusion Criteria: * any other malignancies within the last 5 yea...

Countries:AustraliaAustriaBelgiumCanadaChileChinaCzechiaDenmarkFranceGermanyGreeceHungaryItalyLithuaniaMalaysiaNew ZealandPolandRomaniaRussiaSlovakiaSloveniaSouth AfricaSouth KoreaSpainUkraineUnited KingdomVenezuela
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about Alimta or Taxotere

What is Alimta or Taxotere used for?

Alimta or Taxotere is used for the treatment of non-small cell lung cancer (NSCLC). It is an investigational small molecule being studied in the oncology therapeutic area. The drug is currently in Phase 3 clinical development for this indication.

Who makes Alimta or Taxotere?

Alimta or Taxotere is being developed by Roche Holding AG, a biopharmaceutical company. Roche's stock is traded under the ticker symbol RHHBY. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with non-small cell lung cancer.

What phase is Alimta or Taxotere in?

Alimta or Taxotere is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial for this drug has been completed, and it is no longer actively recruiting patients.

What clinical trials is Alimta or Taxotere in?

Alimta or Taxotere was studied in a Phase 3 clinical trial with the identifier NCT00556322. This completed trial enrolled 424 patients with advanced, recurrent, or metastatic non-small cell lung cancer. The study was conducted across multiple countries, including Australia, Canada, China, France, Germany, and the United Kingdom.

Is Alimta or Taxotere the same as Tarceva?

Alimta or Taxotere is not the same as Tarceva. The clinical trial NCT00556322 studied a combination of Tarceva (erlotinib) and standard of care chemotherapy, which included Alimta or Taxotere. These are distinct drugs with different mechanisms of action, and they were evaluated together in the trial.