Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-small-cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Metastases, Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lonafarnib (SARASAR) | Drug | Lonafarnib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available