A randomized phase II study of paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches in patients with stage IV non-squamous-non-small cell lung cancer: NVALT12

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 222

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.

Exclusion Criteria

* Clinically significant (i.e. active) cardiovascular disease: congestive heart failure >NYHA class 2; CVA or myocardial infarction < 6 months prior to study entry; uncontrolled hypertension (blood pressure systolic > 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.

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 (ORR) and disease control rate (DCR), Duration of<br /><br>response, OS, Safety.</p><br>

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