Advanced Nsclc Clinical Trial
Official title:
Study of Thalidomide With First-line Chemotherapy and as Maintenance Treatment of Advanced Nonsquamous NSCLC With Epidermal Growth Factor Receptor Wild-Type or Unknown Mutation Status: A Multicenter, Randomized, Prospective Clinical Trial
The study for innovative strategies is warranted in the treatment of advanced non-squamous NSCLC with epidermal growth factor receptor wild-type or unknown mutation status because the outcomes remain unsatisfactory for most patients. Maintenance treatment after first-line chemotherapy is a very interesting strategy that has been largely investigated in the last years. This study is to evaluate the efficacy and toxicity of thalidomide in combination with chemotherapy and as maintenance treatment in patients with advanced non-squamous NSCLC.
Status | Recruiting |
Enrollment | 232 |
Est. completion date | November 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. stage ? non-squamous NSCLC with epidermal growth factor receptor wild-type or unknown mutation status confirmed by molecular biology and histology. 2. age 18-70 years. 3. Eastern Cooperative Oncology Group performance status of 0 or 1 and life expectancy greater than 3 months. 4. no previous treatment with chemotherapy or radiotherapy 5. adequate bone marrow, hepatic, and renal function 6. measurable or evaluable disease 7. informed consent 8. negative pregnancy test and adequate contraception for the duration of treatment Exclusion Criteria: 1. malignancy during the 5 years previous to the diagnosis of NSCLC (unless nonmelanoma skin cancer or early cervical cancer) 2. surgery within 4 weeks 3. history of major hemoptysis 4. recent history of bleeding or thrombotic events 5. brain metastasis 6. uncontrolled hypertension 7. ongoing therapeutic anticoagulation |
Country | Name | City | State |
---|---|---|---|
China | Qilu hospital of Shandong University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Qilu Hospital of Shandong University |
China,
Gridelli C, Maione P, Rossi A. The PARAMOUNT trial: a phase III randomized study of maintenance pemetrexed versus placebo immediately following induction first-line treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer. Rev Recent Clin Trials. 2013 Mar;8(1):23-8. — View Citation
Iwasaki A, Kuwahara M, Yoshinaga Y, Shirakusa T. Basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF) levels, as prognostic indicators in NSCLC. Eur J Cardiothorac Surg. 2004 Mar;25(3):443-8. — View Citation
Lee SM, James L, Buchler T, Snee M, Ellis P, Hackshaw A. Phase II trial of thalidomide with chemotherapy and as maintenance therapy for patients with poor prognosis small-cell lung cancer. Lung Cancer. 2008 Mar;59(3):364-8. Epub 2007 Oct 24. — View Citation
Sandler A, Yi J, Dahlberg S, Kolb MM, Wang L, Hambleton J, Schiller J, Johnson DH. Treatment outcomes by tumor histology in Eastern Cooperative Group Study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer. J Thorac Oncol. 2010 Sep;5(9):1416-23. doi: 10.1097/JTO.0b013e3181da36f4. — View Citation
Villa C, Cagle PT, Johnson M, Patel JD, Yeldandi AV, Raj R, DeCamp MM, Raparia K. Correlation of EGFR mutation status with predominant histologic subtype of adenocarcinoma according to the new lung adenocarcinoma classification of the International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society. Arch Pathol Lab Med. 2014 Oct;138(10):1353-7. doi: 10.5858/arpa.2013-0376-OA. Epub 2014 Feb 26. — View Citation
Zhou S, Wang F, Hsieh TC, Wu JM, Wu E. Thalidomide-a notorious sedative to a wonder anticancer drug. Curr Med Chem. 2013;20(33):4102-8. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | progression-free survival (PFS) | Addition of thalidomide to chemotherapy and as single maintenance treatment is associated with similar PFS with Control Arm. | 2 year | |
Secondary | objective response rate(ORR) | Response rates are similar in the two treatment groups | 2 years | |
Secondary | weight | Thalidomide can increase the weight of the patient | 2 years | |
Secondary | vascular endothelial growth factor (VEGF) VEGF | Thalidomide can decrease the level of VEGF | 1 year |
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