advanced non-small cell lung cancer MedDRA version: 14.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Transiderm Nitro 25 mg 10 cm2
Product Name: Transiderm-Nitro 5
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Tansiderm-Nitro
CAS Number: 55-63-0
Current Sponsor code: na
Othe
Sponsors
NVALT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of a stage III or IV non-small cell lung carcinoma (including cytology obtained by brushings, washings or needle aspirations; and/or sputum cytology positive on at least 2 occasions). Patients with stage III disease must not be candidates for subsequent surgery and/or chemoradiotherapy) [Refer to Appendix 3]. Measurable disease is not required. 2. ECOG performance status of 0, 1 or 2 at the time of randomisation [Appendix 4]. 3. Adequate bone-marrow, renal and hepatic function as follows: Haemoglobin = 100 g/l Absolute neutrophil count =1.5 x 109/L Platelet count =100 x 109/L Serum bilirubin =1.5 times ULN (Upper Limit of Normal) Alanine transaminase (ALT) =2.5 times ULN if liver metastases not evident 18 years of age. 8. If the patient is female, then she must be either of non-childbearing potential (i.e. be post-menopausal, or have a current tubal ligation, hysterectomy or oophorectomy) or if of childbearing potential, then she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test (serum or urine) and continue such precautions during all study treatment period and for 2 months after completion of chemotherapy. 9. Written informed consent 10. Plan to start chemotherapy within 8 days of randomisation 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1. Untreated brain or meningeal metastases 2. Life expectancy less than 3 months. 3. Any prior systemic therapy for advanced non-small lung cancer including cytotoxic drugs, anti EGF or anti VEGF drugs. Adjuvant chemotherapy for non-small cell lung cancer completed more than 12 months before randomisation is allowed. 4. History of previous or concomitant malignancies at other sites within the last 5 years. Exceptions: Effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured. 5. On nitrates, dihydroergotamine or phosphodiesterase inhibitors (e.g. sildenafil) 6. History of allergic disease or reactions likely to be exacerbated by nitroglycerin. 7. Uncontrolled cardiovascular disease, including symptomatic congestive cardiac failure, symptomatic coronary artery disease, or clinically significant hypotension. 8. Other concurrent medical problems, unrelated to the malignancy, which would limit compliance with the study procedures or expose the patient to unacceptable risk. 9. Active and uncontrolled infections 10. Psychiatric or addictive disorders that may compromise their ability to give informed consent, or to comply with the trial procedures. 11. Any investigational or non-registered medicinal product within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period. 12. For female patients: the patient is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression-free survival;Secondary Objective: 1. Overall survival (OS) 2. Objective tumour response rates (OTRR) 3. Adverse events (AE) 4. Health-related quality of life (HRQL);Primary end point(s): Progression-free survival (time from randomisation to progression or death, primary endpoint) ;Timepoint(s) of evaluation of this end point: Continuously | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival (time from randomisation to death from any cause) 2. Frequency of complete response, partial response, and stable disease at 6 months according to RECIST 1.1 (see Appendix 5). 68 3. Patients’ ratings of HRQL with the EORTC QLQ-C30, QLQ-LC13, UBQ-C, Patient DATA Form, and EQ5-D (see Appendix 7). 4. Clinicians’ ratings of patients with Spitzers’ Quality of Life Index (see Appendix 7), ECOG performance scale (see Appendix 4). 5. Adverse events categorised and graded according to NCI Common Terminology Criteria for Adverse Events v3.0. (See Appendix 6). 6. Compliance, duration of therapy and reasons for discontinuation expressed in terms of: o numbers of cycles of chemotherapy completed o duration of study treatment and reasons for stopping o dose-intensity of given chemotherapeutics.;Timepoint(s) of evaluation of this end point: Continuously | — |
Countries
Australia, Netherlands, New Zealand
Contacts
Public Contactprincipal investigator
NVALT
Outcome results
None listed