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

T

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)

100 participants in 1 patient group

Triplet Combination of TLK286 Carboplatin & Paclitaxel
Experimental group
Description:
Experimental
Treatment:
Drug: paclitaxel
Drug: TLK286
Drug: carboplatin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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