A multicentre, phase III, randomised, double-blind, placebo-controlled trial of pravastatin added to first-line chemotherapy in patients with small cell lung cancer

ISRCTN ISRCTN56306957
DOI https://doi.org/10.1186/ISRCTN56306957
ClinicalTrials.gov (NCT) NCT00433498
Clinical Trials Information System (CTIS) 2005-005821-71
Protocol serial number BRD/05/129
Sponsor University College London (UK)
Funder Cancer Research UK (CRUK) (UK) (ref: C1312/A5335)
Submission date
07/04/2006
Registration date
08/05/2006
Last edited
25/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-for-small-cell-lung-cancer-looking-at-chemotherapy-with-or-without-pravastatin

Contact information

Prof Michael Seckl
Scientific

Department of Medical Oncology
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Study information

Primary study designInterventional
Study designMulticentre phase III randomised double-blind placebo-controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA multicentre, phase III, randomised, double-blind, placebo-controlled trial of pravastatin added to first-line chemotherapy in patients with small cell lung cancer
Study acronymLungStar
Study objectivesTo see if the addition of pravastatin to standard combination chemotherapy (cisplatin and etoposide or carboplatin and etoposide) improves response rates, time to disease progression, and survival in patients with Small Cell Lung Cancer (SCLC).

On 15/02/2011 the following changes were made to the trial record:
1. The anticipated end date was changed from 30/04/2010 to 31/10/2011.
2. The target number of participants was changed from 1300 to 860.
Ethics approval(s)Multicentre Research Ethics Committee for Scotland, 19/04/2006, ref: 06/MRE10/28
Health condition(s) or problem(s) studiedSmall cell lung cancer
InterventionAll patients receive standard chemotherapy: Cisplatin/Etoposide or Carboplatin/Etoposide. They are then randomised prior to or within one working day of starting chemotherapy to:

1. Pravastatin daily for two years
2. Placebo daily for two years

Assessments with each cycle of chemotherapy then, follow up post chemotherapy, two monthly to one year from randomisation then three monthly thereafter.
Intervention typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)Pravastatin, cisplatin, carboplatin, etoposide
Primary outcome measure(s)

To determine in patients with SCLC if survival is affected by the addition of pravastatin to either cisplatin/etoposide or carboplatin/etoposide

Key secondary outcome measure(s)

To compare the treatments in terms of:
1. Progression-free survival
2. Local progression-free survival (local control)
3. Response rates
4. Toxicity

Completion date31/10/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration860
Key inclusion criteria1. Histologically or cytologically confirmed SCLC
2. Limited or extensive disease
3. Performance status Eastern Cooperative Oncology Group (ECOG) zero to three
4. Life expectancy more than 8 weeks
5. Age 18 or over
6. Willing and able to give informed consent
7. Patient considered able to tolerate chemotherapy
8. Adequate renal function - defined by glomerular filtration rate (GFR) more than 50 ml/min if measured by EthyleneDiamineTetraacetic Acid (EDTA) or GFR more than 40 ml/min if measured by the Cockcroft and Gault (C & G) formula. Cisplatin and etoposide dose should be modified according to renal function as per dose modification schedule.
9. Adequate bone marrow reserve - Absolute Neutrophil Count (ANC) more than 1.5 x 10^9 /l, Haemoglobin (Hb) more than 10.0 g/dl and platelet count more than 100 x 10^9 /l
10. Liver function tests less than three times Upper Limit of Normal (ULN)
11. Creatine Kinase less than or equal to five times ULN
Key exclusion criteria1. Prior chemotherapy for this disease (protocol chemotherapy should start after randomisation except for where a patient needs to start chemotherapy urgently, randomisation may occur a maximum of one working day after day one of cycle one)
2. Prior radiotherapy for this disease (except for prior radiotherapy to distant metastases i.e. not within the thorax or thoracic or cervical spine is acceptable)
3. 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
4. Patients with a family history of hypercholesterolaemia
5. 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
6. Patients treated with fibrates e.g. bezofibrate, gemfibrozil, fenofibrate within four weeks prior to randomisation
7. Patients on cyclosporin
8. Patients with symptomatic brain metastases, which require immediate radiotherapy
9. 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 or placebo
10. Treatment with any statin within previous 12 months
Date of first enrolment01/06/2006
Date of final enrolment31/10/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Medical Oncology
London
W6 8RF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/05/2017 Yes No
Basic results No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Plain English results 25/10/2022 No Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link added.
19/03/2020: EudraCT number added. Added EudraCT link to basic results (scientific).
16/03/2017: Publication reference added

BMC - Part of Springer Nature Springer Nature