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Study of Thalidomide in Treatment of Advanced Nsclc (Dream-003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03062800
Recruitment Status : Unknown
Verified June 2019 by Qilu Hospital of Shandong University.
Recruitment status was:  Recruiting
First Posted : February 23, 2017
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Nsclc Drug: Thalidomide Drug: pemetrexed Drug: cisplatin Drug: carboplatin Phase 2

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. objective response rate(ORR) [ Time Frame: 2 years ]
    Response rates are similar in the two treatment groups

  2. weight [ Time Frame: 2 years ]
    Thalidomide can increase the weight of the patient

  3. vascular endothelial growth factor (VEGF) VEGF [ Time Frame: 1 year ]
    Thalidomide can decrease the level of VEGF


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  1. stage Ⅳ 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Xiuwen Wang, MD.PhD +86 13791123979 wangxiuwen@medmail.com.cn
Contact: Shuguang Li, MD.PhD +86-0531-82169841 lishuguang96@163.com

Locations
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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.         
Sponsors and Collaborators
Qilu Hospital of Shandong University
Investigators
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Principal Investigator: Xiuwen Wang, MD.PhD Qilu Hospital of Shandong University
More Information
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Publications:

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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
Keywords provided by Qilu Hospital of Shandong University:
thalidomide
pemetrexed
nsclc
maintenance treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
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
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