metastatic non-squamous non-small-cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV
Conditions
Interventions
Trade Name: Nitroglycerin transdermal patch 25 mg
Product Name: Nitroglycerin transdermal patch
Pharmaceutical Form: Transdermal patch
CAS Number: 55630
Other descriptive name: GLYCERYL TRINITRATE
Con
Sponsors
Stichting NVALT Studies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically/cytologically proven stage IV non-squamous NSCLC (according to IASLC staging 7.0) • No prior chemotherapy or therapy with systemic anti-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the HER axis (e.g. EGFR TK inhibitors, Herceptin). Prior surgery and/or localized palliative irradiation is permitted provided that the irradiated lesion is not the only measurable lesion. Prior adjuvant chemotherapy > 1 year ago and prior treatment with an EGFR-TKI for patients with an activating EGFR mutation is allowed. • Age = 18 years. • ECOG Performance Status of 0 – 2. • Life expectancy of at least 12 weeks. • Subjects with at least one uni-dimensional(for RECIST) measurable lesion. • Adequate bone marrow, liver and renal function (see protocol for details). • Adequate non-hormonal contraception for females of childbearing potential during the study and in the 6 months thereafter. • Adequate contraception for male participants (or their partners) during the study and in the 6 months thereafter. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Clinically significant (i.e. active) cardiovascular disease: congestive heart failure >NYHA class 2; CVA or myocardial infarction 150 mmHg and/or diastolic > 100 mmHg). • Symptomatic hypotension. • History of hemoptysis at least grade 2 (bright red blood of at least 2,5 ml in the last 3 months) • Evidence of tumor invading major blood vessels on imaging (i.e. superior vena cava or pulmonary artery). • History of HIV infection or chronic hepatitis B or C. • Active clinically serious infection • Symptomatic metastatic brain or meningeal tumors. Patients with brain metastasis may be included the patient is treated with brain radiotherapy and asymptomatic. • History of organ allograft. • Patients with evidence or history of bleeding diathesis. • Non-healing wound or ulcer. • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment • Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry • Radiotherapy within 4 weeks of start of study drug. Palliative radiotherapy for bone lesions is allowed > 14 days of start of chemotherapy. Major surgery within 4 weeks of start of study. • Use of vasodilators (including 5-fosfodiesterase inhibitors, calcium antagonists or nitrates) • Autologous bone marrow transplant or stem cell rescue within 4 months of study • Investigational drug therapy outside of this trial during or within 4 weeks of study entry • Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Objective response rate (ORR) and disease control rate (DCR), Duration of response, OS, Safety.;Primary end point(s): Progression free survival.;Main Objective: The addition of NTG patches to bevacizumab containing chemotherapy (experimental arm) improves PFS in patients with stage IV non-squamous NSCLC, compared to bevacizumab containing chemotherapy without NTG (control arm) | — |
Countries
Netherlands
Outcome results
None listed