Completed

Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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What is being tested

Data Collection

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: February 2004
See protocol details

Summary

Principal SponsorTelik
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 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 combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.

Official TitlePhase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer 
NCT00077883
Principal SponsorTelik
Last updated: January 14, 2026
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

50 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 * Stage IV or IIIB * Measurable disease by RECIST * ECOG performance status of 0-1 * Adequate liver and renal function * Adequate bone marrow reserve Exclusion Criteria: * 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.
Study Objectives

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 3 locations

Suspended

Univ. of MD, Greenbaum Cancer Center

Baltimore, United StatesSee the location
Suspended

The Sarah Cannon Cancer Center

Nashville, United States
Suspended

Univ. of TX, MD Anderson Cancer Center

Houston, United States
Completed3 Study Centers