Efficacy Trial of Gemcitabine Containing Regimens As Preoperative Chemotherapy in Non Small Cell Lung Cancer

Randomized Phase II Trial to Outline the Efficacy of Gemcitabine Containing Regimens (Gemcitabine/Carboplatin and Gemcitabine/Paclitaxel) When Used as Preoperative Chemotherapy In Patients With Stage I and II NSCLC

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191256

Enrollment

Registered

2005-09-19

Start date

2001-06-30

Completion date

2006-07-31

Last updated

2007-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non Small Cell Lung

Brief summary

To evaluate the rate of complete pathological response after 3 cycles of gemcitabine containing chemotherapy.

Interventions

DRUGGemcitabine

DRUGCarboplatin

DRUGPaclitaxel

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically or cytologically confirmed non small cell lung cancer * No prior chemotherapy or radiation for non small cell lung cancer * No prior malignancy

Exclusion criteria

* Pregnancy or breastfeeding * Serious concomitant disorders

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate, in previously untreated patients with clinical Stage I and II non-small cell lung cancer (NSCLC).	—

Secondary

Measure	Time frame
Response rate, disease free survival,toxicities including pulmonary toxicity, operative mortality, and quality of life.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026