Non-small Cell Lung Cancer Clinical Trial
Official title:
A Randomized Open Label Phase II Trial Comparing BIBW2992 Plus Simvastatin With BIBW2992 Plus Best Supportive Care in Previously Treated Patients With Advanced (Stage IIIB/IV) Non-adenocarcinomatous Non-small Cell Lung Cancer (NSCLC)
Verified date | April 2022 |
Source | National Cancer Center, Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators hypothesized that simvastatin may enhance sensitivity to BIBW 2992 in non-adenocarcinoma that is relatively resistant to TKIs. Based on these data, the investigators will research the effectiveness comparing BIBW2992, an irreversible EGFR-TKI, plus simvastatin with BIBW2992 alone in the setting of a randomized phase II study in previously treated patients with advanced non-adenocarcinomatous non-small cell lung cancer (NSCLC).
Status | Completed |
Enrollment | 68 |
Est. completion date | June 9, 2021 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Pathologically confirmed diagnosis of Stage IIIB or Stage IV non-adenocarcinomatous non-small cell lung cancer (e.g., squamous cell or large cell carcinoma).(The 7th edition of the TNM classification for lung cancer47-See Appendix 6) 2. Progressive disease following the first or second line cytotoxic chemotherapy regimen(s) including at least one platinum-containing regimen. 3. Measurable disease according to RECIST 1.1.40 4. Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2.41 5. Age = 18 years. 6. Life expectancy of at least three (3) months. 7. Written informed consent that is consistent with ICH-GCP guidelines. Exclusion Criteria: 1. More than three (3) prior cytotoxic chemotherapy treatment regimen for relapsed or metastatic NSCLC. 2. Prior treatment with EGFR targeting small molecules or antibodies (e.g., gefitinib, erlotinib, cetuximab). 3. Chemotherapy, hormonal therapy (other than megestrol acetate or steroids required for maintenance non-cancer therapy), immunotherapy or surgery (other than biopsy) within 4 weeks prior to study entry. 4. Radiotherapy within 2 weeks prior to study entry. Only palliative radiotherapy to non-target lesion should be allowed for the entered cases. 5. Active brain metastases with clinically significant neurological symptoms or signs. Patients with brain metastasis are allowed unless there were clinically significant neurological symptoms or signs. 6. Any other current malignancy or malignancy diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer). 7. Known pre-existing interstitial lung disease. 8. Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. Crohn's disease, malabsorption or CTC grade =2 diarrhea of any etiology. 9. Absolute neutrophil count (ANC) <1500 / mm3. 10. Platelet count < 100,000 / mm3. 11. Serum creatinine >1.5 times upper limit of normal (ULN) or creatinine clearance < 60 ml / min 12. Bilirubin > 1.5 times upper limit of normal. 13. Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 3 times the upper limit of normal (ULN) (if related to liver metastases > 5 times ULN). 14. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to study entrance. 15. Cardiac left ventricular function with resting ejection fraction of less than 50%. 16. Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug. 17. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial. 18. Pregnancy or breast-feeding. 19. Patients unable to comply with the protocol. 20. Active hepatitis B infection, active hepatitis C infection or known HIV carrier. 21. Known or suspected active drug or alcohol abuse. 22. Requirement for treatment with any of the prohibited concomitant medications listed in Section 4.2.2. 23. Any contraindications for therapy with simvastatin. 24. Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs. 25. Use of any investigational drug within 4 weeks of randomization (unless a longer time period is required by local regulations). |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Cancer Center | Goyang-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea | Boehringer Ingelheim |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate | Repeat tumor assessments will be performed after the completion of Week 4, Week 8, and in 8-week intervals thereafter until progression or withdrawal for another reason | each 8 weeks | |
Secondary | Disease Control Rate | Repeat tumor assessments will be performed after the completion of Week 4, Week 8, and in 8-week intervals thereafter until progression or withdrawal for another reason | every 8 weeks | |
Secondary | Progression-Free Survival | Repeat tumor assessments will be performed after the completion of Week 4, Week 8, and in 8-week intervals thereafter until progression or withdrawal for another reason | every 8 weeks | |
Secondary | Overall Survival | Overall survival (OS) will be calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurs first. | every 12 weeks | |
Secondary | Adverse event | For grading of adverse events CTC AE criteria (version 4.0) will be utilizedStatistical analysis and reporting of adverse events will concentrate on treatment-emergent adverse events. To this end, all adverse events occurring between first drug intake until 28 days (inclusive) after last treatment administration will be considered 'treatment-emergent'. Adverse events that start before first drug intake and deteriorate under treatment will also be considered as 'treatment-emergent'. | first drug intake until 28 days after last treatment administration | |
Secondary | Pharmacogenetic and biomarkers analyses | The primary focus of predictive biomarker analyses is to investigate potential relationships of certain biomarkers with efficacy or safety endpoints. For this study, predictive efficacy analyses will be performed with such biomarkers as EGFR mutation status. EGFR mutation status will be measured in tumor samples and blood samples. In addition, plasma levels of IGFBP-3 and amphiregulin as well as gene polymorphisms related to the EGFR and IGF-1R pathways will be investigated. | every 8 weeks |
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