A Phase III, Randomised, Double-blind, Multi-centre, Parallel Group Study to Compare the Efficacy of Cediranib (AZD2171, RECENTIN™) (30 mg) When Added to Gemcitabine and Cisplatin versus the Efficacy of Placebo When Added to Gemcitabine and Cisplatin in Patients with Locally Advanced or Metastatic (Stage IIIb/IV) Non Small Cell Lung Cancer.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 650

Inclusion Criteria

1. Provision of informed consent
2. Male or female aged 18 years and older
3. Histological or cytological confirmation of locally advanced or metastatic non-small cell lung cancer (NSCLC) on entry into the study.
4. Patients with stage IIIb/IV NSCLC who are not candidates for combined modality treatment with chemotherapy and radiotherapy.
5. No prior systemic therapy for metastatic or recurrent NSCLC except prior adjuvant therapy for completely resected disease, providing completed at least 12 months prior to randomisation
6. World Health Organisation (WHO) performance status 0-1
7. Life expectancy > 12 weeks
8. One or more measurable lesions at least 10 mm in the longest diameter by spiral computed tomography (CT) scan or 20 mm with conventional techniques (RECIST criteria)
9. Patients considered by the Investigator to be suitable for orally administered treatment

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

1. Mixed small cell and non small cell lung cancer histology
2. Prior treatment with chemotherapy or other systemic anti-cancer therapy including adjuvant therapy within 12 months prior to study entry
3. CTC grade 2 or greater pre-existing motor or sensory neuropathy
4. Known hypersensitivity to cediranib and any of its excipients
5. Known hypersensitivity to gemcitabine or cisplatin and any of their excipients
6. Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF and VEGF receptors including bevacizumab and cediranib
7. Prior radiation therapy =28 days prior to randomisation on the study, except palliative radiotherapy
8. Serum creatinine = institutional normal upper limit, or a creatinine clearance of = 60 ml/min calculated by Cockcroft-Gault
9. Untreated unstable brain or meningeal metastases. Patients with radiological evidence of stable brain metastases are eligible providing that they are asymptomatic and either do not require corticosteroids or have been treated with corticosteroids, with clinical and radiological evidence of stabilisation at least 10 days after discontinuation of steroids
10. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count =1.5 x 10(to power 9)/L or platelet count =100 x 10(to power 9)/L or requiring regular blood transfusions to maintain haemoglobin >9g/dL
11. Serum bilirubin = 1.5 x ULRR (except for patients with known documented cases of Gilbert’s syndrome)
12. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) = 2.5 x ULRR. If liver metastases are present, ALT or AST > 5 x ULRR
13. Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein < 1.5g in a 24 hour period
14. History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib, including the ability to swallow the tablet whole
15. Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilise blood pressure
16. Any evidence of severe or uncontrolled diseases e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease
17. Unresolved toxicity > CTC grade 1 from previous anti-cancer therapy (including radiotherapy) except haematological toxicity (see criteria 10) and alopecia (if applicable)
18. Mean QTc with Bazetts correction >470msec in screening ECG or history of familial long QT syndrome
19. Significant haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks)
20. Recent (<14 days) major thoracic or abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed
21. Pregnant or breast-feeding women or women of childbearing potential with a positive pregnancy test prior to receiving study medication
22. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the primary cancer of interest from a target lesion
23. Known risk of the patient transmitting Human Immunodeficiency Virus (HIV), hepatitis B or C via infected blood
24. Involvement in the planning and conduct of the s

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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