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

NCT03062800 | Unknown Phase 2 DMC

• 1 other identifier: Dream-003
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Nsclc

Keywords

thalidomide; pemetrexed; nsclc; maintenance treatment

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  Addition of thalidomide to chemotherapy and as single maintenance treatment is associated with similar PFS with Control Arm.

  2 year

Secondary Outcomes (3)

• objective response rate(ORR)

  2 years

• weight

  2 years

• vascular endothelial growth factor (VEGF) VEGF

  1 year

Study Arms (2)

P+Cisplatin/Carboplatin+T

EXPERIMENTAL

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

P+Cisplatin/Carboplatin

EXPERIMENTAL

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

Interventions

Thalidomide DRUG

100-200mg/d,oral ,qn

Also known as: H32026128

P+Cisplatin/Carboplatin+T

pemetrexed DRUG

(500mg/m\^2) on day 1 of 21-days cycle,ivgtt

Also known as: H20090232

P+Cisplatin/Carboplatin; P+Cisplatin/Carboplatin+T

cisplatin DRUG

(75mg/m\^2) on day 1 of 21-days cycle, ivgtt

Also known as: H20040813

P+Cisplatin/Carboplatin; P+Cisplatin/Carboplatin+T

carboplatin DRUG

(AUC=5) on day 1 of 21-days cycle, ivgtt

Also known as: H20020180

P+Cisplatin/Carboplatin; P+Cisplatin/Carboplatin+T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (6)

• Villa C, Cagle PT, Johnson M, Patel JD, Yeldandi AV, Raj R, DeCamp MM, Raparia K. Correlation of EGFR mutation status with predominant histologic subtype of adenocarcinoma according to the new lung adenocarcinoma classification of the International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society. Arch Pathol Lab Med. 2014 Oct;138(10):1353-7. doi: 10.5858/arpa.2013-0376-OA. Epub 2014 Feb 26.

  PMID: 24571650 BACKGROUND

• Sandler A, Yi J, Dahlberg S, Kolb MM, Wang L, Hambleton J, Schiller J, Johnson DH. Treatment outcomes by tumor histology in Eastern Cooperative Group Study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer. J Thorac Oncol. 2010 Sep;5(9):1416-23. doi: 10.1097/JTO.0b013e3181da36f4.

  PMID: 20686429 BACKGROUND

• Iwasaki A, Kuwahara M, Yoshinaga Y, Shirakusa T. Basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF) levels, as prognostic indicators in NSCLC. Eur J Cardiothorac Surg. 2004 Mar;25(3):443-8. doi: 10.1016/j.ejcts.2003.11.031.

  PMID: 15019676 BACKGROUND

• Gridelli C, Maione P, Rossi A. The PARAMOUNT trial: a phase III randomized study of maintenance pemetrexed versus placebo immediately following induction first-line treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer. Rev Recent Clin Trials. 2013 Mar;8(1):23-8. doi: 10.2174/15748871112079990040.

  PMID: 23259416 BACKGROUND

• Zhou S, Wang F, Hsieh TC, Wu JM, Wu E. Thalidomide-a notorious sedative to a wonder anticancer drug. Curr Med Chem. 2013;20(33):4102-8. doi: 10.2174/09298673113209990198.

  PMID: 23931282 BACKGROUND

• Lee SM, James L, Buchler T, Snee M, Ellis P, Hackshaw A. Phase II trial of thalidomide with chemotherapy and as maintenance therapy for patients with poor prognosis small-cell lung cancer. Lung Cancer. 2008 Mar;59(3):364-8. doi: 10.1016/j.lungcan.2007.08.032. Epub 2007 Oct 24.

  PMID: 17920723 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thalidomide; Pemetrexed; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Xiuwen Wang, MD.PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuwen Wang, MD.PhD

CONTACT

+86 13791123979; wangxiuwen@medmail.com.cn

Shuguang Li, MD.PhD

CONTACT

+86-0531-82169841; lishuguang96@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 23, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: November 1, 2021
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)