|- candidate number||16152|
|- NTR Number||NTR4410|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-jan-2014|
|- Secondary IDs||2013-004303-39 EudraCT number|
|- Public Title||Erlotinib and chemotherapy for advanced lung cancer. The NVALT-17 study|
|- Scientific Title||A randomized phase III study of erlotinib compared to intercalated erlotinib with cisplatinum pemetrexed as first-line therapy for advanced EGFR mutated non-small-cell lung cancer. The NVALT-17 study|
|- hypothesis||The combination of cisplatin-pemetrexed-erlotinib is superior to standard of care erlotinib monotherapy as first line treatment in prolonging progression free survival in patients with advanced NSCLC whose tumors harbor an EGFR mutation.|
|- Healt Condition(s) or Problem(s) studied||EGFR mutation, Non small cell lung cancer (NSCLC)|
|- Inclusion criteria||• Histologically/cytologically proven stage III or IV NSCLC.
• Tumor treatment-naive.
• Documented activating EGFR mutation in exon 18, 19 or exon 21.
• Measurable disease.
• Age ≥ 18 years.
• Males and females.
• ECOG Performance Status of 0 – 3.
• Life expectancy > 12 weeks.
• Adequate contraception for females of childbearing potential.
• Adequate contraception for male participants.|
|- Exclusion criteria||• Documented brain metastasis.• Concomitant treatment with experimental medicines, potent CYP3A4 inhibitors or inducers.
• Previous cytotoxic chemotherapy for lung cancer less than 2 years before study entry.
• For curatively treated lung cancer: (adjuvant) chemotherapy or chemo-radiotherapy less than 12 month prior to the study entry.
• Pregnancy or lactation. |
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2014|
|- planned closingdate||1-jan-2019|
|- Target number of participants||150|
|- Interventions||Treatment with erlotinib or cisplatin-pemetrexed-erlotinib.|
|- Primary outcome||Progression free survival.|
|- Secondary outcome||Objective response rate and disease control rate, overall survival, safety.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. T.J.N. Hiltermann|
|- CONTACT for SCIENTIFIC QUERIES||Dr. T.J.N. Hiltermann|
|- Sponsor/Initiator ||NVALT|
(Source(s) of Monetary or Material Support)
|- Brief summary||Objectives: Primary: To compare progression-free survival (PFS) between erlotinib alone and cisplatin-pemetrexed-erlotinib in patients with EGFR mutated NSCLC locally advanced and metastatic disease stage IIIB and IV.
Secondary: To characterize toxicities of both treatment regimen, tumor response, quality of life, duration of tumor response and overall survival and correlate baseline cMet status with overall survival.
Study design Multicenter randomized open phase III parallel group study.
Patient will be randomly allocated to either:
• Control Arm: erlotinib 150 mg/day days until disease progression. A treatment cycle of erlotinib is described a 21 day usage of the treatment.
• Experimental Arm: 4 cycles of cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 on Day 1 plus erlotinib 150 mg/day days 2-16 every 21 days. After 4 cycles of chemotherapy, patients will continue with maintenance pemetrexed 500mg/m2 on Day 1 plus erlotinib 150 mg/day days 2-16 every 21 days until disease progression.
Treatment duration: till disease progression.
Approx. 150 patients.
Population: Patients with locally advanced or metastatic EGFR mutated NSCLC, tumor treatment-naive. Age 18 years and above.
Primary variable variabele: Progression free survival.
Secondary variabeles: Objective response rate and disease control rate, overall survival, safety.|
|- Main changes (audit trail)|
|- RECORD||22-jan-2014 - 9-mei-2014|