A Phase 2 interventional study of Thalidomide and pemetrexed in Advanced Nsclc, sponsored by Qilu Hospital of Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-05.
Sponsored by Qilu Hospital of Shandong University · Phase 2, Interventional, and Treatment
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.
Lung cancer is the most common cancer and is the leading cause of cancer mortality in the world. Every year, more than one million people die from lung cancer in worldwide. NSCLC accounts for about 85% of all lung cancers diagnosis and continues to remain a major therapeutic challenge.
Chemotherapeutic agents in the treatment of advanced NSCLC have reached a plateau of effectiveness when administered in the classic modality. In the first-line treatment of advanced non-squamous NSCLC with epidermal growth factor receptor wild-type, cisplatin plus pemetrexed is considered the best chemotherapeutic regimen. Recently, the PARAMOUNT trial has demonstrated that continuation maintenance with pemetrexed improves progression-free survival and overall survival after induction therapy with cisplatin plus pemetrexed in advanced non-squamous NSCLC with epidermal growth factor receptor wild-type.
Bevacizumab, a pure humanized anti-VEGF monoclonal antibody (mAb) has improved the outcomes of chemotherapy alone when combined with chemotherapy as first-line therapy for advanced non-squamous NSCLC. A randomized phase Ⅲ trial named Eastern Cooperative Oncology Group E4559 has demonstrated that concurrent bevacizumab with chemotherapy followed by maintenance bevacizumab in previously untreated patients with advanced non-squamous NSCLC is associated with an increase in overall survival.
In China, the cost of continuation maintenance with pemetrexed or bevacizumab is high in the current economic environment.
Thalidomide is much cheaper than pemetrexed and bevacizumab, and has been shown to have activity in numerous malignancies. Although the exact anti-tumor mechanism is unknown, thalidomide exhibits both immuno-modulating and anti-angiogenic effects. Based on potentially synergistic mechanisms of action, thalidomide has the potential to enhance the activity of conventional chemotherapy. Results from previously published small studies in which thalidomide was given concurrently with conventional chemotherapy and was continued as maintenance therapy suggest that thalidomide might be effective in the treatment of patients with small cell lung cancer and NSCLC. Study and evaluation the efficacy and toxicity of thalidomide in combination with chemotherapy and as maintenance treatment in patients with advanced non-squamous NSCLC with epidermal growth factor receptor wild-type is necessary.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 232 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.
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Exclusion Criteria:
Induction therapy (Platinum based chemotherapy combined with antiangiogenic therapy 4-6 cycles): Pemetrexed + Platinum + Thalidomide \[pemetrexed (500mg/m\^2)+cisplatin(75mg/m\^2)or carboplatin(AUC=5) on day 1 of 21-days cycle, ivgtt +thalidomide 100-200mg/d ,oral, qn \] Continue maintenance therapy (It is defined when a drug included in the induction treatment is used as maintenance .Patients who had not progressed during induction phase will be in this phase): Thalidomide 100mg/d ,oral, qn, until either disease progression or unacceptable toxicity.
Drug: Thalidomide · Drug: pemetrexed · Drug: cisplatin · Drug: carboplatin
Induction therapy ( Platinum based chemotherapy 4-6 cycles): Pemetrexed + Platinum \[pemetrexed (500mg/m\^2)+cisplatin(75mg/m\^2)or carboplatin(AUC=5) on day 1 of 21-days cycle,ivgtt \] Maintenance therapy (It is defined when a drug included in the induction treatment is used as maintenance .Patients who had not progressed during induction phase will be in this phase): Pemetrexed (500mg/m\^2) on day 1 of 21-days cycle, ivgtt.until either disease progression or unacceptable toxicity
Drug: pemetrexed · Drug: cisplatin · Drug: carboplatin
100-200mg/d,oral ,qn
Also known as: H32026128
(500mg/m\^2) on day 1 of 21-days cycle,ivgtt
Also known as: H20090232
(75mg/m\^2) on day 1 of 21-days cycle, ivgtt
Also known as: H20040813
(AUC=5) on day 1 of 21-days cycle, ivgtt
Also known as: H20020180
progression-free survival (PFS)
Addition of thalidomide to chemotherapy and as single maintenance treatment is associated with similar PFS with Control Arm.
Time frame: 2 year
objective response rate(ORR)
Response rates are similar in the two treatment groups
Time frame: 2 years
weight
Thalidomide can increase the weight of the patient
Time frame: 2 years
vascular endothelial growth factor (VEGF) VEGF
Thalidomide can decrease the level of VEGF
Time frame: 1 year
Plan to share: No
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Qilu Hospital of Shandong University