Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED)

A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin vs. Placebo in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00050336

Enrollment

702

Registered

2002-12-05

Start date

2002-12-31

Completion date

2004-03-31

Last updated

2015-08-27

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, Metastases, Neoplasm

Keywords

Stage 3b or 4 (metastatic) non-small cell lung cancer

Brief summary

The purpose of this study is to determine the overall survival of patients diagnosed with Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin with that of patients treated with placebo in combination with paclitaxel and carboplatin.

Interventions

DRUGLonafarnib (SARASAR)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female * Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol. * Age greater than or equal to 18 years old * ECOG performance status of 0 to 1 * Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified. * Meets protocol requirements for specified laboratory values * Written informed consent * Appropriate use of effective contraception if of childbearing potential * Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided they have been treated with no evidence of disease

Exclusion criteria

* Prior chemotherapy for any stage of NSCLC * Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy * Concurrent treatment or treatment within the last 2 years for any other malignancy * Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication) * Medical conditions that would interfere with taking oral medications * Patients with bone metastases as the only site of disease * Pregnant or nursing women * Known HIV positivity or AIDS-related illness * Patients with significant QTc prolongation at baseline

Outcome results

None listed

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