Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.

Detailed Description
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TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel. After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.

Official Title
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Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Chemotherapy Induced Neutropenia in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Receiving First-Line Chemotherapy

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: ezatiostat hydrochloride (Telintra®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed NSCLC Stage IIIb-Stage IV NSCLC ECOG performance status of 0-2 Adequate liver and renal function Adequate bone marrow reserve Exclusion Criteria: Treatment with neoadjuvant or adjuvant chemotherapy within 1 year Histologically confirmed mixed tumors containing small cell elements Treatment with radiotherapy (except limited in nature) within 3 weeks of randomization History of bone marrow transplantation or stem cell support Known history of CNS metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or IV steroids or anticonvulsants History of HIV Grade 3 or 4 peripheral neuropathy Weightloss greater than 5% within 6 months Uncontrolled pleural effusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ezatiostat hydrochloride (Telintra®)<br>Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery | Drug: ezatiostat hydrochloride (Telintra®)<br>* 4500 mg orally per day in two divided doses<br>* Other names: ezatiostat tablets;|
| No Intervention: No Intervention<br>Chemotherapy with docetaxel and carboplatin alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of chemotherapy induced neutropenia |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of chemotherapy induced severe neutropenia |  | 6 weeks | 
| Time to ANC recovery from ANC nadir |  | 6 weeks | 
| Incidence of febrile neutropenia |  | 6 weeks | 
| Incidence of G-CSF administration |  | 6 weeks | 
| FACT-N quality of life assessment |  | 6 weeks | 
| safety assessments |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Chemotherapy induced neutropenia, CIN