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

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 - NVALT17

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45179

Enrollment

150

Registered

2013-11-21

Start date

2014-05-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Treatment with erlotinib or cisplatin-pemetrexed-intercalated erlotinib.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Progression free survival.	—

Secondary

Measure	Time frame
Objective response rate, quality of life and disease control rate, overall survival, safety.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)