Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03123484
Other study ID # CLOG1702
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received April 5, 2017
Last updated April 18, 2017
Start date April 2017
Est. completion date October 2019

Study information

Verified date April 2017
Source China Medical University, China
Contact Liu yunpeng, PhD
Phone 86 24 83282312
Email cmu_trial@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Epidermal Growth Factor Receptor tyrosine-kinase inhibitors (EGFR-TKIs), including gefitinib,erlotinib and icotinib demonstrate excellent effect on the treatment of non small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. In this study, the investigators aim to explore the efficacy of beta-elemene, combining with EGFR-TKI in advanced non-small cell lung cancer with EGFR-TKI resistance.


Description:

Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), including gefitinib,erlotinib and icotinib demonstrate excellent effect on the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. Beta-elemene, a natural plant drug extracted from Curcuma wenyujin, has been used as an antitumor drug for different tumors, including NSCLC via mechanism that inhibits Ras/Mapk signaling and cell cycle progression.In this study, the investigators aim to explore the efficacy of beta-elemene, combining with EGFR-TKI in advanced non-small cell lung cancer with EGFR-TKI resistance.

main objectives: progression-free survival (PFS) ratio in 12 week the secondary goal: Objective Response Rate (ORR)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date October 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Obtain of informed consent.

2. Histologically or cytologically confirmed, inoperable, recurrence or metastasis advanced non-small cell lung cancer (TNM Stage ?B or stage ?), took EGFR-TKI longer than 6 months and appeared disease progression.

3. At least one measurable lesion (helical CT scan long diameter =10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors(RESCIST) version 1.1).

4. Eastern Cooperative Oncology Group(ECOG)Performance Status(PS) :0-2.

5. Aged from 18 to 75 years (18 and 75 years are included).

6. Life expectancy =12 weeks.

7. Adequate bone marrow reserve and organ function as follows:

Absolute neutrophils count (ANC) =1.5 x 10 to the 9th power/L (band neutrophil and segmented neutrophil), platelets > 100 x 10 to the 9th power/L and Hb=90g/L.

Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN).

Alkaline phosphatase (AP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 3.0 times ULN (or less than or equal to 5 times ULN in case of known liver involvement.

Renal: Serum Creatinine less than or equal to 1.25 times upper limit of normal (ULN).

8. Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.

Exclusion Criteria:

1. Do not meet the above criteria.

2. Unhealed toxicity of prior anti-cancer treatment (CTCAE Level 1) or surgery.

3. Symptomatic Central Nervous System (CNS) metastases.

4. Clinical uncontrolled active infection, such as acute pneumonia, active hepatitis B or C (prior hepatitis B history, despite medication treatment control or not, HBV DNA=500copies or =100IU/ml), etc.

5. Prior other malignant disease in 5 years (except carcinoma in situ of cervix, or non melanoma skin cancers, or localized prostate cancer with Gleason =6).

6. Take part in new drug clinical trials within one month or taking part in a trial now.

7. Pregnant or lactating woman.

8. Other conditions regimented at investigators' discretion.

Study Design


Intervention

Drug:
ß-elemene
ß-elemene:400-600mg + 5%GS 500ml,ivgtt,qd, continuously 45days
EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)
EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) as usual

Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
China Medical University, China General Hospital of Shenyang Military Region, Liaoning Tumor Hospital & Institute, Shengjing Hospital, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University

References & Publications (5)

Li QQ, Wang G, Huang F, Li JM, Cuff CF, Reed E. Sensitization of lung cancer cells to cisplatin by ß-elemene is mediated through blockade of cell cycle progression: antitumor efficacies of ß-elemene and its synthetic analogs. Med Oncol. 2013 Mar;30(1):488. doi: 10.1007/s12032-013-0488-9. Epub 2013 Feb 9. — View Citation

Liu J, Hu XJ, Jin B, Qu XJ, Hou KZ, Liu YP. ß-Elemene induces apoptosis as well as protective autophagy in human non-small-cell lung cancer A549 cells. J Pharm Pharmacol. 2012 Jan;64(1):146-53. doi: 10.1111/j.2042-7158.2011.01371.x. Epub 2011 Oct 27. — View Citation

Matsuoka H, Kaneda H, Sakai K, Koyama A, Nishio K, Nakagawa K. Clinical Response to Everolimus of EGFR-Mutation-Positive NSCLC With Primary Resistance to EGFR TKIs. Clin Lung Cancer. 2017 Jan;18(1):e85-e87. doi: 10.1016/j.cllc.2016.08.004. Epub 2016 Oct 4. — View Citation

Passiglia F, Listì A, Castiglia M, Perez A, Rizzo S, Bazan V, Russo A. EGFR inhibition in NSCLC: New findings…. and opened questions? Crit Rev Oncol Hematol. 2017 Apr;112:126-135. doi: 10.1016/j.critrevonc.2017.02.009. Epub 2017 Feb 16. Review. — View Citation

Xu XW, Yuan ZZ, Hu WH, Wang XK. [Meta-analysis on elemene injection combined with cisplatin chemotherapeutics in treatment of non-small cell lung cancer]. Zhongguo Zhong Yao Za Zhi. 2013 May;38(9):1430-7. Chinese. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary PFS ratio in 12 week progression free survival ratio in 12 week 12 week
Secondary OR Rate Objective Response Rate 12 week
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Completed NCT01945021 - Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC Phase 2
Completed NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Terminated NCT04022876 - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Phase 1
Recruiting NCT05898763 - TEIPP Immunotherapy in Patients With NSCLC Phase 1/Phase 2
Recruiting NCT05532696 - Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients Phase 1/Phase 2
Completed NCT04311034 - A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Terminated NCT03257722 - Pembrolizumab + Idelalisib for Lung Cancer Study Phase 1/Phase 2
Completed NCT00349089 - Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy Phase 2
Completed NCT05116891 - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04571632 - Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors Phase 2
Terminated NCT03599518 - DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer Phase 1
Not yet recruiting NCT06020989 - Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy Phase 2
Withdrawn NCT03982134 - PDR001 + Panobinostat for Melanoma and NSCLC Phase 1
Withdrawn NCT03574649 - QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer Phase 2
Withdrawn NCT02844140 - DE-CT in Lung Cancer Proton Therapy N/A
Completed NCT03780010 - Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC Phase 1