CEDAR
- Conditions
- Advanced squamous cell lung cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000199-25-GB
- Lead Sponsor
- Queen Mary, University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 86
1Written informed consent prior to admission to this study
2Histologically confirmed squamous cell lung cancer; patients with adenosquamous or mixed histology are not eligible for this study
3Stage IIIB disease that is unsuitable to radio-chemotherapy or Stage IV disease or recurrent NSCLC; recurrent disease must not be amenable to resection or radical radiotherapy with curative intent.
4Patients must have:
•at least one lesion, not previously irradiated, that can be measured accurately at baseline as =10 mm in the longest diameter (except lymph nodes which must have short axis =15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements
OR
•lytic or mixed (lytic + sclerotic) bone lesions in the absence of measurable disease as defined above; NOTE: patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible
5. Willing to donate archival diagnostic tissue for translational research, if available.
6. Haematologic and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to randomisation
•ANC =1.5 x 109/L;, platelet count =100 x 109/L,
•Serum creatinine < 1.5 times the upper limit of normal (ULN)
•Bilirubin level < 1.5 X ULN
•AST or ALT <3.0 X ULN or <5 X ULN in the presence of liver metastases
7. ECOG performance status 0-2
8. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, bilateral oophorectomy, bilateral tubular ligation or is post-menopausal (total cessation of menses for = 1 year; if the patient is of childbearing potential, she must have a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception (for example, intrauterine device [IUD], birth control pills unless clinically contraindicated, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product.Male patients must be surgically sterile or agree to use adequate contraception
9.Male or Female aged =18 years
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
1. Symptomatic CNS involvement or CNS involvement requiring steroid therapy; patients with treated brain metastases that are asymptomatic and have been clinically stable for 1 month will be eligible for protocol participation
2. Previous systemic treatment for lung cancer (exception for patients with recurrent disease: adjuvant chemotherapy is allowed as long as this was finished at least 1 year prior to enrolment and did not contain gemcitabine)
3. Known tumour EGFR mutation, unless contraindication to EGFR-directed therapy
4. Known tumour ALK rearrangements, unless contraindication to Alk-directed therapy or Alk-directed therapy not available 1
5. Pre-existing sensory or motor polyneuropathy = Grade 2 according to NCI CTCAE
6. Significant cardiovascular disease, such as
•History of myocardial infarction, acute coronary syndromes (including unstable angina), or history of coronary angioplasty/stenting/bypass grafting within past 6 months.
• History of symptomatic congestive heart failure (CHF) New York Heart Association (NYHA) Classes III-IV or LVEF <50% by either ECHO or MUGA within past 6 months.
• Severe cardiac arrhythmia requiring medication or severe conduction abnormalities
• Poorly controlled hypertension (resting diastolic blood pressure >115 mmHg)
• Clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, or cardiomyopathy
7. Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.
8. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry.
9. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
10. Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
11.Pregnant or nursing women
12.Male or Female aged <18 years
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