TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00077883

Enrollment

Registered

2004-02-16

Start date

2004-02-29

Completion date

2007-03-31

Last updated

2011-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

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.

Interventions

DRUGTLK286, cisplatin

TLK286 administered once every 3 weeks (± 2 days) at two dose-ranging levels (750 mg/m²) and 1,000 mg/²) in combination with two dose levels of cisplatin (75 mg/m² and 100 mg/m²) of cisplatin once every 3 weeks (± 2 days).

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Objectives of the Study	Every 3 weeks	1. To determine the safety of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) 2. To determine the MTD of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026