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A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer

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Lilly

Status and phase

Completed
Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Gemcitabine
Drug: docetaxel
Drug: cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191490
6549
B9E-IT-JHSC

Details and patient eligibility

About

Phase II study that will evaluate the activity of gemcitabine as intravesical therapy on the marker lesion in superficial bladder carcinoma at intermediate risk. Primary objective is the evaluation of the pathological complete response after 8 instillation of gemcitabine. 46 patients are requested.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of NSCLC
  • Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System
  • Patients must have at least one measurable lesion
  • WHO Performance Status 0 or 1
  • Adequate Organ Function

Exclusion criteria:

  • Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant treatments
  • Prior radiotherapy for NSCLC
  • Patients with symptomatic brain metastases or with leptomeningeal disease. However, patients with symptomatic brain metastases who become asymptomatic under corticosteroids treatment can enter the study
  • Current peripheral neuropathy NCI grade 2

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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