A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy for advanced non-small cell lung cancer (NITRO TRIAL, NVALT-21 study)

Phase 3

Completed

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

• Registration Number: NL-OMON38964
• Lead Sponsor: Stichting NVALT studies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Stage III or IV non-small cell lung carcinoma. Measurable disease is not required.
2. ECOG performance status of 0, 1 or 2.
3. Radiotherapy completed at least 1 week before randomisation.
4. At least 18 years of age.
5. Adequate contraception for 30 days prior to drug administration for females of childbearing potential.

Exclusion Criteria

1. Untreated brain or meningeal metastases.
2. Life expectancy less than 3 months.
3. Any prior systemic therapy for advanced NSCLC. Adjuvant chemotherapy for NSCLC completed more than 12 months before randomisation is allowed.
4. On nitrates, dihydroergotamine or phosphodiesterase inhibitors.
5. Uncontrolled cardiovascular disease.
6. Pregnancy, 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>Overall survival, objective tumour response rates, adverse events, quality of<br /><br>life.</p><br>