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, 2004Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bronchial Neoplasms
Carcinoma, Bronchogenic
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic 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

Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²

AUC 6 mg/mL/min Once every 3 weeks

200 mg/m² Once every 3 weeks
Study Objectives
Primary Objectives

1. To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 2. To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 3. To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin

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 GroupConcord, United StatesSee the location
Suspended
East Bay Medical Oncology/Hematology AssociatesConcord, United States
Suspended
Southwest Cancer CareEscondido, United States
Suspended
Kaiser Permanente Medical CenterHayward, United States
Completed52 Study Centers