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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 3

Conditions

Carcinoma, Non-small-cell Lung

Metastases, Neoplasm

Treatments

Drug: Lonafarnib (SARASAR)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00050336

P01901

Details and patient eligibility

About

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.

Enrollment

702 patients

Sex

All

Ages

18+ years old

Volunteers

No 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