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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1
4500 mg orally per day in two divided doses
Duration of chemotherapy induced neutropenia
Time frame: 6 weeks
Duration of chemotherapy induced severe neutropenia
Time frame: 6 weeks
Time to ANC recovery from ANC nadir
Time frame: 6 weeks
Incidence of febrile neutropenia
Time frame: 6 weeks
Incidence of G-CSF administration
Time frame: 6 weeks
FACT-N quality of life assessment
Time frame: 6 weeks
safety assessments
Time frame: 6 weeks
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