Study of Thalidomide in Treatment of Advanced Nsclc (Dream-003)
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ClinicalTrials.gov Identifier: NCT03062800 |
Recruitment Status :
Recruiting
First Posted : February 23, 2017
Last Update Posted : June 5, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Nsclc | Drug: Thalidomide Drug: pemetrexed Drug: cisplatin Drug: carboplatin | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 232 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | December 2016 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | November 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: P+Cisplatin/Carboplatin+T
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
100-200mg/d,oral ,qn
Other Name: H32026128 Drug: pemetrexed (500mg/m^2) on day 1 of 21-days cycle,ivgtt
Other Name: H20090232 Drug: cisplatin (75mg/m^2) on day 1 of 21-days cycle, ivgtt
Other Name: H20040813 Drug: carboplatin (AUC=5) on day 1 of 21-days cycle, ivgtt
Other Name: H20020180 |
Experimental: P+Cisplatin/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
(500mg/m^2) on day 1 of 21-days cycle,ivgtt
Other Name: H20090232 Drug: cisplatin (75mg/m^2) on day 1 of 21-days cycle, ivgtt
Other Name: H20040813 Drug: carboplatin (AUC=5) on day 1 of 21-days cycle, ivgtt
Other Name: H20020180 |
- progression-free survival (PFS) [ Time Frame: 2 year ]Addition of thalidomide to chemotherapy and as single maintenance treatment is associated with similar PFS with Control Arm.
- objective response rate(ORR) [ Time Frame: 2 years ]Response rates are similar in the two treatment groups
- weight [ Time Frame: 2 years ]Thalidomide can increase the weight of the patient
- vascular endothelial growth factor (VEGF) VEGF [ Time Frame: 1 year ]Thalidomide can decrease the level of VEGF

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- stage Ⅳ non-squamous NSCLC with epidermal growth factor receptor wild-type or unknown mutation status confirmed by molecular biology and histology.
- age 18-70 years.
- Eastern Cooperative Oncology Group performance status of 0 or 1 and life expectancy greater than 3 months.
- no previous treatment with chemotherapy or radiotherapy
- adequate bone marrow, hepatic, and renal function
- measurable or evaluable disease
- informed consent
- negative pregnancy test and adequate contraception for the duration of treatment
Exclusion Criteria:
- malignancy during the 5 years previous to the diagnosis of NSCLC (unless nonmelanoma skin cancer or early cervical cancer)
- surgery within 4 weeks
- history of major hemoptysis
- recent history of bleeding or thrombotic events
- brain metastasis
- uncontrolled hypertension
- ongoing therapeutic anticoagulation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062800
Contact: Xiuwen Wang, MD.PhD | +86 13791123979 | wangxiuwen@medmail.com.cn | |
Contact: Shuguang Li, MD.PhD | +86-0531-82169841 | lishuguang96@163.com |
China, Shandong | |
Qilu hospital of Shandong University | Recruiting |
Jinan, Shandong, China, 250012 | |
Contact: Shuguang Li, MD. +86 18560082862 lishuguang96@163.com | |
Principal Investigator: Xiuwen Wang, MD. |
Principal Investigator: | Xiuwen Wang, MD.PhD | Qilu Hospital of Shandong University |
Responsible Party: | Qilu Hospital of Shandong University |
ClinicalTrials.gov Identifier: | NCT03062800 |
Other Study ID Numbers: |
Dream-003 |
First Posted: | February 23, 2017 Key Record Dates |
Last Update Posted: | June 5, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
thalidomide pemetrexed nsclc maintenance treatment |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Thalidomide Cisplatin Carboplatin Pemetrexed Antineoplastic Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |