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Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

NCT00050960•Eisai Inc.

View on ClinicalTrials.gov

Summary

This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

Detailed Description

This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have:
•Pathologic (histologic or cytologic) confirmation of NSCLC
•Stage IIIB with malignant pleural effusion or Stage IV disease
•At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy
•ECOG performance status 0 or 1
•Adequate organ system function
•Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).
•Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
•Patients must not have had:
•Brain metastasis
+2 more criteria

Locations (154)

Montgomery Cancer Center, L.L.C.

Montgomery, Alabama, United States

Arizona Clinical Research Center, Inc.

Tucson, Arizona, United States

Bay Area Cancer Research Group, LLC

Concord, California, United States

Compassionate Cancer Care Medical Group, Inc.

Fountain Valley, California, United States

Pacific Coast Hematology/Oncology Medical Group, Inc.

Fountain Valley, California, United States

California Cancer Care, Inc.

Greenbrae, California, United States

Coast Hematology and Oncology Associates

Long Beach, California, United States

Metropolitan Hematology/Oncology Medical Group

Los Angeles, California, United States

Sant P. Chawla, Inc.

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

Key Dates

Start Date

May 1, 2002

Primary Completion Date

July 1, 2004

Completion Date

March 1, 2005

Last Updated

July 13, 2012

Enrollment

612

ACTUAL participants

Conditions

Non-small Cell Lung Cancer

Interventions

bexarotene with carboplatin and paclitaxel

DRUG

carboplatin and paclitaxel

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Inclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)