Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

Lilly

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Procedure: surgery; Drug: gemcitabine; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191126

3532

B9E-MC-S132 (Other Identifier)

Details and patient eligibility

About

Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.

Enrollment: 263 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion Criteria:

• Must have pathologic documentation of non-small cell lung cancer, IB, II, IIIA.
• ECOG Performance Status of 0 - 1
• Bidimensionally measurable disease or evaluable disease
• Adequate organ function

Main exclusion Criteria:

• Have greater than Grade 1 neuropathy - motor/sensory
• Significant history of cardiac disease
• Pleural effusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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263 participants in 2 patient groups

A

Other group

Treatment:

Procedure: surgery

B

Experimental group

Treatment:

Drug: Cisplatin

Drug: gemcitabine

Procedure: surgery