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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
Sponsor:
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Tracking Information
First Submitted Date  ICMJE February 7, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date June 5, 2019
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Thalidomide in Treatment of Advanced Nsclc (Dream-003)
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Nsclc
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Thalidomide
    • Drug: pemetrexed
    • Drug: cisplatin
    • Drug: carboplatin
  • 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

    Interventions:
    • Drug: pemetrexed
    • Drug: cisplatin
    • Drug: carboplatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2017)
232
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiuwen Wang, MD.PhD +86 13791123979 wangxiuwen@medmail.com.cn
Contact: Shuguang Li, MD.PhD +86-0531-82169841 lishuguang96@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03062800
Other Study ID Numbers  ICMJE Dream-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Qilu Hospital of Shandong University
Study Sponsor  ICMJE Qilu Hospital of Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiuwen Wang, MD.PhD Qilu Hospital of Shandong University
PRS Account Qilu Hospital of Shandong University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP