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

Phase 3

Completed

• Conditions: non-small cell lung cancer; lung cancer; 10029107

• Registration Number: NL-OMON45179
• Lead Sponsor: Stichting NVALT studies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

• Histologically/cytologically proven stage III or IV non-sqamous NSCLC.
• Tumor treatment-naive.
• Documented activating EGFR mutation in exon 18, 19 or exon 21.
• Measurable disease.
• Age >= 18 years.
• 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. Exceptions: see protocol page 12.
• Concomitant treatment with experimental medicines, potent CYP3A4 inhibitors or inducers, see protocol page 12 for details.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression free survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Objective response rate, quality of life and disease control rate, overall<br /><br>survival, safety.</p><br>