Clinical trial · Interventional
Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung Cancer
A Multicentre Phase III Randomized Double Blind Placebo Controlled Trial of Pravastatin Added to First-Line Standard Chemotherapy in Patients With Small Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by making tumor cells more sensitive to chemotherapy. It is not yet known whether etoposide and cisplatin or carboplatin are more effective with or without pravastatin in treating small cell lung cancer. PURPOSE: This randomized phase III trial is studying etoposide and cisplatin or carboplatin to see how well they work when given as first-line chemotherapy together with pravastatin compared with first-line chemotherapy and a placebo in treating patients with small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| pravastatin sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carboplatin/cisplatin and Etoposide with Pravastatin
- interventionNames
- Drug: carboplatin
- Drug: cisplatin
- Drug: etoposide phosphate
- Drug: pravastatin sodium
- type
- PLACEBO_COMPARATOR
- label
- Carboplatin/cisplatin and Etoposide with Placebo
- interventionNames
- Drug: carboplatin
- Drug: cisplatin
- Drug: etoposide phosphate
Primary outcomes (1)
- measure
- Survival
- timeFrame
- Reported at death.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer * Limited stage or extensive stage disease * No mixed cell histology * No symptomatic brain metastases that require immediate radiotherapy PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Life expectancy \> 8 weeks * Platelet count \> 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count \> 1,500/mm\^3 * Glomerular filtration rate ≥ 50 mL/min * Creatine kinase ≤ 5 times upper limit of normal (ULN) * Liver function tests (ALP, ALT/AST, and bilirubin) \< 3 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 1 year after completion of chemotherapy/radiotherapy and for an additional 28 days after completion of pravastatin sodium * Able to tolerate chemotherapy * No evidence of significant medical condition or laboratory finding that, in the opinion of the investigator, would preclude study participation * No family history of hypercholesterolemia * No history of malignant tumor unless the patient has been without evidence of disease for ≥ 3 years or tumor was a nonmelanoma skin tumor or early cervical cancer PRIOR CONCURRENT THERAPY: * More than 12 months since prior statin * More than 4 weeks since prior fibrates (e.g., bezofibrate, gemfibrozil, or fenofibrate) * No prior chemotherapy for this cancer * No prior radiotherapy for this cancer unless to distant metastases (i.e., not within the thorax or thoracic/cervical spine area) * No concurrent cyclosporine * Concurrent radiotherapy allowed
References
Publications (0)
Data not yet available