Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Michael Seckl


Contact details

Department of Medical Oncology
Charing Cross Hospital
Fulham Palace Road
W6 8RF
United Kingdom
+44 (0)20 8846 1421

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Lungstar 2

Study hypothesis

To determine if survival is affected by the addition of pravastatin to docetaxel and cisplatin/carboplatin chemotherapy in patients with non-small cell lung cancer (NSCLC).

Ethics approval

Approval pending

Study design

Double-blind placebo-controlled multicentre phase III study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Stage 3B that is unsuitable for chemoradiation and stage 4 non-small cell lung cancer


Patients will receive chemotherapy with docetaxel and either carboplatin or cisplatin. They will be randomised to either pravastatin or placebo. Chemotherapy will last for four cycles unless there is evidence of progression or occurrence of unacceptable toxicities. Oral pravastatin or placebo will commence on day 1 of the first chemotherapy cycle.

Study entrants will be required to undergo all standard staging investigations. They will be required to provide a pre-chemotherapy full blood count as well as urea, creatinine and liver function tests before each cycle of chemotherapy. A staging computerised tomography (CT) scan will be performed mid-treatment (post cycle 2) and at the end of chemotherapy. A separate consent will be obtained for the collection of additional blood samples and tissue for translational research. A quality of life and toxicity questionnaire will be required at each visit.

Intervention type



Phase III

Drug names

Pravastatin, docetaxel, cisplatin, carboplatin

Primary outcome measures

To determine if survival is affected by the addition of pravastatin to docetaxel and cisplatin/carboplatin chemotherapy in patients with non-small cell lung cancer.

Secondary outcome measures

1. Progression-free survival
2. Response rates and clinical benefit
3. Toxicity
4. Symptom control and quality of life

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Histological or cytological-confirmed NSCLC
2. Stage IV disease or stage IIIB disease that is unsuitable for radio-chemotherapy
3. Presence of one or more measurable lesions (by Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
4. Estimated life expectancy of at least 12 weeks
5. Performance status 0, 1 or 2
6. Aged 18 or over
7. Patients must be able to give informed consent
8. Adequate haematological function (absolute neutrophil count [ANC] greater than 1.5 x 10^9 /l, platelets greater than 100 x 10^9 /l, and haemoglobin greater than 9 g/dl)
9. Adequate renal function: ethylenediaminetetraacetic acid (EDTA) based glomerular filtration rate of greater than 55 ml/min or a 24-hour creatinine clearance of greater than 60 ml/min
10. Adequate hepatobiliary function: serum bilirubin less than 1.5 times the upper limit of normal (ULN) and serum aspartate aminotransferase (AST) and/or alanine transaminase (ALT) less than 2.5 x ULN in patients without liver involvement or less than 5.0 x ULN in patients with liver metastases
11. Patient compliance and geographic proximity allowing for adequate follow-up
12. Female patients potentially able to bear children should use an approved contraceptive method (intrauterine device [IUD], birth control pills or barrier device) during and for three months after the study. All male patients should take adequate contraceptive precautions during and up to two months after the study
13. Written informed consent prior to admission to this study

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Presence of central nervous system metastases
2. Prior chemotherapy or radiotherapy for this disease
3. Protocol chemotherapy should start after randomisation (except for example when a patient needs to start chemotherapy urgently, randomisation may occur at a maximum of one working day after day 1 of cycle 1 but consent to the trial must always be obtained prior to starting chemotherapy)
4. Creatinine kinase greater than or equal to 5 x ULN
5. Patients treated with statins (e.g. simvastatin, pravastatin, atorvastatin) within one year prior to randomisation
6. Patients treated with fibrates (e.g. bezofibrate, gemfibrozil, fenofibrate) within four weeks prior to randomisation
7. Patients on cyclosporine
8. Hypersensitivity to docetaxel, carboplatin, cisplatin or pravastatin or any of their excipients
9. Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
10. Evidence of uncontrolled infection
11. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
12. A history of prior malignant tumour, unless the patient has been without evidence of disease for at least three years or the tumour was a non-melanoma skin tumour or early cervical cancer
13. Pregnancy and lactation; effective contraception is mandatory for all patients of reproductive potential if sexually active whilst in the study. Contraception should continue for one year post completion of all chemotherapy or radiotherapy and a further 28 days after cessation of pravastatin/placebo

Recruitment start date


Recruitment end date



Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Department of Medical Oncology
W6 8RF
United Kingdom

Sponsor information


Imperial College London (UK)

Sponsor details

Hammersmith Campus
Hammersmith Hospital
Du Cane Road
W12 0HS
United Kingdom
+44 (0)20 8383 5828

Sponsor type




Funder type


Funder name

Sanofi-Aventis (UK) - supplied a grant of £350,000 for investigator-led study

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Clinical Trials Advisory and Awards Committee (CTAAC) (UK) - application pending for additional funding for the translational research aspect of the study

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes