Clinical trial · Interventional
Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study TLK199.2102 was terminated for lack of enrollment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ezatiostat hydrochloride (Telintra®) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ezatiostat hydrochloride (Telintra®)
- description
- Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery
- interventionNames
- Drug: ezatiostat hydrochloride (Telintra®)
- type
- NO_INTERVENTION
- label
- No Intervention
- description
- Chemotherapy with docetaxel and carboplatin alone
Primary outcomes (1)
- measure
- Duration of chemotherapy induced neutropenia
- timeFrame
- 6 weeks
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available