Completed

Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

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What is being tested

TLK286

+ carboplatin

+ paclitaxel

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: August 2004
See protocol details

Summary

Principal SponsorTelik
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2004

Actual date on which the first participant was enrolled.

The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.

Official TitlePhase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer 
NCT00088556
Principal SponsorTelik
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

Inclusion Criteria: * 18 years of age or older * Histologically confirmed non-small cell lung cancer (NSCLC) * Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation) * Measurable disease by RECIST * ECOG status of 0-1 * Adequate liver and renal function * Adequate bone marrow reserves Exclusion Criteria: * Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC * Up to one prior adjuvant or neoadjuvant chemotherapy is allowed * History of bone marrow transplantation or stem cell support * Pregnant or lactating women

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 52 locations

Suspended

Bay Area Cancer Research Group

Concord, United StatesSee the location
Suspended

East Bay Medical Oncology/Hematology Associates

Concord, United States
Suspended

Southwest Cancer Care

Escondido, United States
Suspended

Kaiser Permanente Medical Center

Hayward, United States
Completed52 Study Centers