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Platinum+ Gemcitabine

Phase 2

Non-Small-Cell Lung Carcinoma | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Oct 28, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Platinum+ Gemcitabine · 1 trial · 1 indication

Phase 2 1
NCT00112346Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung CancerNon-Small-Cell Lung Carcinoma
COMPLETED120 Analytics
PHASE2COMPLETED
Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Non-Small-Cell Lung CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

tumor response per treatment arm

Secondary Endpoints

disease control, symptom response, symptomatic progression, & progression free survival.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Cetuximab + platinum + gemcitabineDRUGSolution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 \& Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance.
Platinum + GemcitabineDRUGSolution, IV, Gemcitabine given at 1250mg/m2 (Day 1 \& Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy. * Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva). * Must not have had hypersensiti...

Countries:United StatesCanada
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Frequently asked questions about Platinum+ Gemcitabine

What is Platinum+ Gemcitabine used for in Non-Small-Cell Lung Carcinoma?

Platinum+ Gemcitabine is a combination chemotherapy regimen being studied for the first-line treatment of patients with advanced or metastatic Non-Small-Cell Lung Carcinoma. It is an investigational small molecule therapy in Phase 2 clinical development, evaluated in a completed clinical trial.

Who makes Platinum+ Gemcitabine?

Platinum+ Gemcitabine is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The company sponsored the clinical trial evaluating this combination regimen for Non-Small-Cell Lung Carcinoma.

What phase is Platinum+ Gemcitabine in?

Platinum+ Gemcitabine is in Phase 2 clinical development. It is an investigational combination therapy, not yet approved by regulatory authorities. The Phase 2 trial for Non-Small-Cell Lung Carcinoma has been completed, and the drug remains under clinical investigation.

What clinical trials is Platinum+ Gemcitabine in?

Platinum+ Gemcitabine was evaluated in a single completed Phase 2 clinical trial with the identifier NCT00112346. The study, titled "Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer," enrolled 120 participants in the United States and Canada.

Is Platinum+ Gemcitabine the same as Gemcitabine/Platinum?

Yes, Platinum+ Gemcitabine is the same as the Gemcitabine/Platinum combination regimen. The clinical trial NCT00112346 refers to the treatment as Gemcitabine/Platinum, and the drug is also known by the name Platinum+ Gemcitabine in the context of this study.

What does the Platinum+ Gemcitabine clinical trial involve?

The Phase 2 trial NCT00112346 was a randomized, active-controlled study comparing Gemcitabine/Platinum with or without Cetuximab as first-line treatment for advanced or metastatic Non-Small-Cell Lung Cancer. It enrolled 120 adults aged 18 years and older in the United States and Canada, and the trial has been completed.