A trial of adding nitroglycerin tochemotherapy for advanced lung cancer

• Conditions: advanced non-small cell lung cancer; MedDRA version: 14.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002050-78-NL
• Lead Sponsor: VALT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-09
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

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 <5 times
ULN if liver metastases are evident
Serum creatinine =1.5 times (ULN)
or
Calculated creatinine clearance = 50ml/min
4. Radiotherapy completed at least 1 week before randomisation (a 3-week gap is recommended for
radiation including significant volumes of lung or bone marrow).
5. The patient is willing and able to comply with the requirements of the protocol and will be accessible for
follow-up
6. Has completed the HRQL questionnaires or is unable to complete them because of illiteracy,
insufficient english, or limited vision.
7. Patient is >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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified