Erlotinib and chemotherapy for advanced lung cancer. The NVALT-17 study

• Conditions: Advanced EGFR mutated non-small-cell lung cancer

• Registration Number: NL-OMON27429
• Lead Sponsor: Stichting NVALT studiesLuijbenstraat 155211 BR Den BoschThe Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival.

Secondary Outcome Measures

Name	Time	Method
Objective response rate and disease control rate, overall survival, safety.