Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

Telik

Status and phase: Completed; Phase 2; Phase 1

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: carboplatin; Drug: paclitaxel; Drug: TLK286

Study type: Interventional

Funder types: Industry

Identifiers

NCT00088556

TLK286.2023

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Triplet Combination of TLK286 Carboplatin & Paclitaxel

Experimental group

Description:

Experimental

Treatment:

Drug: paclitaxel

Drug: TLK286

Drug: carboplatin