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

June 3, 2019 updated by: Qilu Hospital of Shandong University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

232

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Principal Investigator:
          • Xiuwen Wang, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • H32026128
Drug: pemetrexed
(500mg/m^2) on day 1 of 21-days cycle,ivgtt
Other Names:
  • H20090232
Drug: cisplatin
(75mg/m^2) on day 1 of 21-days cycle, ivgtt
Other Names:
  • H20040813
Drug: carboplatin
(AUC=5) on day 1 of 21-days cycle, ivgtt
Other Names:
  • 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 Names:
  • H20090232
Drug: cisplatin
(75mg/m^2) on day 1 of 21-days cycle, ivgtt
Other Names:
  • H20040813
Drug: carboplatin
(AUC=5) on day 1 of 21-days cycle, ivgtt
Other Names:
  • H20020180

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate(ORR)
Time Frame: 2 years
Response rates are similar in the two treatment groups
2 years
weight
Time Frame: 2 years
Thalidomide can increase the weight of the patient
2 years
vascular endothelial growth factor (VEGF) VEGF
Time Frame: 1 year
Thalidomide can decrease the level of VEGF
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Principal Investigator: Xiuwen Wang, MD.PhD, Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dream-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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