Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC)

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: gemcitabine; Drug: etoposide; Drug: cisplatin; Drug: docetaxel; Radiation: radiation therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191139

B9E-US-S182 (Other Identifier)

4697

Details and patient eligibility

About

To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologic or cytologic proof of single primary non-small cell lung cancer
• No prior chemotherapy or radiation therapy
• no prior malignancy

Exclusion criteria

• pregnancy or breastfeeding
• serious concomitant systemic disorder
• unintentional weight loss greater than 10%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Gemcitabine

Experimental group

Treatment:

Radiation: radiation therapy

Drug: cisplatin

Drug: etoposide

Drug: gemcitabine

Gemcitabine plus Docetaxel

Experimental group

Treatment:

Radiation: radiation therapy

Drug: cisplatin

Drug: docetaxel

Drug: etoposide

Drug: gemcitabine