Gefitinib for EGFR Sensitive Mutation Postoperative Stage Ib NSCLC Patients

NCT02526537 | Terminated DMC

• 1 other identifier: TSCI001
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, whether adjuvant therapy should be applied to Stage Ib non-small cell lung cancer (NSCLC) patients who received radical resection remains controversial. There is still no clear evidence that the postoperative adjuvant chemotherapy or other treatments can improve the survival rate for patients with stage Ib NSCLC. Tyrosine Kinase Inhibitors (TKIs) such as Gefitinib and Erlotinib are widely accepted as the first-line therapy for Epidermal growth factor receptor (EGFR) gene mutation late stage NSCLC patients. However the effect is largely uncertain for early stage patients who received surgery. The investigators aim to evaluate the effect of postoperative adjuvant use of Gefitinib for high risk stage Ib EGFR sensitive mutation NSCLC patients.

Conditions

NSCLC

Keywords

Gefitinib; NSCLC; postoperative; stage Ib; Relapse Free Survival in 2 years

Outcome Measures

Primary Outcomes (1)

• Relapse Free Survival in 2 years

  Treatment period: 2 years (24 months)

Secondary Outcomes (3)

• Relapse Free Survival in 3 years

  Follow-up: 3 years

• 5 year Overall Survival

  Follow-up: 5 years

• Relapse Free Survival in 5 years

  Follow-up: 5 years

Study Arms (2)

Gefitinib

Stage IB NSCLC Patients with high risk factors and EGFR gene sensitive mutation who can not tolerate or decline chemotherapy and choose Gefitinib for postoperative therapy (Gefitinib 250 mg daily for 2 years).

Non-specific treatment

Stage IB NSCLC Patients with high risk factors and EGFR gene sensitive mutation who can not tolerate or decline chemotherapy and choose Non-specific treatment.(Chinese herbal medicine and nonspecific immunomodulators as adjuvant anti-cancer treatment for 2 years).

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

NSCLC patients received complete resection at stage Ib with deletion of exon 19 or mutation of L858R at exon 21 in EGFR

You may qualify if:

• High-risk who meet one of the following descriptions: 1). Poorly differentiated carcinoma (including neuroendocrine tumors); 2). Vascular invasion; 3). Tumor diameter≥4cm 5). Visceral pleura involvement.
• Patients with pathology confirmed Ib stage NSCLC
• Patients with deletion of exon 19 or mutation of L858R at exon 21 in EGFR gene
• ECOG score of 0-1
• Life expectancy over 12 weeks
• Absolute neutrophil count (ANC) \>= 1.75 x 109 / L, platelet \>= 100 x 109 / L, hemoglobin is more than or equal to 9 g / dl
• Total bilirubin \<= the normal value of 1.5 times the upper limit of normal (ULN); liver metastases, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \<= 2.5 times of upper limit of normal (ULN)
• Serum creatinine \<=1.25 times of the upper limit of normal value, creatinine clearance rate \> 60 or ml/min
• received the informed consent from patient or his/her legal representative

You may not qualify if:

• Patients who was serious allergy to any of the ingredients of drugs used in this study
• Patients who unable to comply with the study plan or research program;
• Patients with severe systemic disease that the researchers judged will be unable to complete the study;
• Patients have severe heart disease, such as myocardial infarction within 6 months;
• Patients have interstitial pneumonia;
• Patients who were confirmed to be positive pathology for cutting edge;
• The preoperative chest CT showed nodules \>= 50%, and showed ground glass opacity;
• Patients received wedge resection;
• Patients used HER2 pathways involved drugs such as erlotinib, gefitinib, cetuximab rituximab, trastuzumab)
• Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy);
• Patients received radiotherapy;
• Having other malignant tumors in the last 5 years, but not including who has been cured through surgery and survived 5 year of disease-free;
• Any unstable systemic diseases (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction, serious arrhythmias, liver, kidney or metabolic diseases within six months).
• Patients who do not get effective treatment of inflammation, eye infections or predisposing factors;
• Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study;

Sponsors & Collaborators

• Lunxu Liu: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, China

Location

Related Publications (8)

• Wu YL, Zhong WZ, Li LY, Zhang XT, Zhang L, Zhou CC, Liu W, Jiang B, Mu XL, Lin JY, Zhou Q, Xu CR, Wang Z, Zhang GC, Mok T. Epidermal growth factor receptor mutations and their correlation with gefitinib therapy in patients with non-small cell lung cancer: a meta-analysis based on updated individual patient data from six medical centers in mainland China. J Thorac Oncol. 2007 May;2(5):430-9. doi: 10.1097/01.JTO.0000268677.87496.4c.

  PMID: 17473659 BACKGROUND

• Strauss GM, Herndon JE 2nd, Maddaus MA, Johnstone DW, Johnson EA, Harpole DH, Gillenwater HH, Watson DM, Sugarbaker DJ, Schilsky RL, Vokes EE, Green MR. Adjuvant paclitaxel plus carboplatin compared with observation in stage IB non-small-cell lung cancer: CALGB 9633 with the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol. 2008 Nov 1;26(31):5043-51. doi: 10.1200/JCO.2008.16.4855. Epub 2008 Sep 22.

  PMID: 18809614 BACKGROUND

• D'Angelo SP, Janjigian YY, Ahye N, Riely GJ, Chaft JE, Sima CS, Shen R, Zheng J, Dycoco J, Kris MG, Zakowski MF, Ladanyi M, Rusch V, Azzoli CG. Distinct clinical course of EGFR-mutant resected lung cancers: results of testing of 1118 surgical specimens and effects of adjuvant gefitinib and erlotinib. J Thorac Oncol. 2012 Dec;7(12):1815-1822. doi: 10.1097/JTO.0b013e31826bb7b2.

  PMID: 23154553 BACKGROUND

• Tsuboi M, Kato H, Nagai K, Tsuchiya R, Wada H, Tada H, Ichinose Y, Fukuoka M, Jiang H. Gefitinib in the adjuvant setting: safety results from a phase III study in patients with completely resected non-small cell lung cancer. Anticancer Drugs. 2005 Nov;16(10):1123-8. doi: 10.1097/00001813-200511000-00012.

  PMID: 16222155 BACKGROUND

• Janjigian YY, Park BJ, Zakowski MF, Ladanyi M, Pao W, D'Angelo SP, Kris MG, Shen R, Zheng J, Azzoli CG. Impact on disease-free survival of adjuvant erlotinib or gefitinib in patients with resected lung adenocarcinomas that harbor EGFR mutations. J Thorac Oncol. 2011 Mar;6(3):569-75. doi: 10.1097/JTO.0b013e318202bffe.

  PMID: 21150674 BACKGROUND

• Zhang Shunda, Deng Yanming, Feng Weineng, Chen Zecheng. Clinical Effects of Gefitinib Tablets in Auxiliary Treatment of Non-small Cell Lung Cancer and its Influencing Factors. Anti-tumor Pharmacy2013, 3(4): 278-281.

  BACKGROUND

• Goss GD, O'Callaghan C, Lorimer I, Tsao MS, Masters GA, Jett J, Edelman MJ, Lilenbaum R, Choy H, Khuri F, Pisters K, Gandara D, Kernstine K, Butts C, Noble J, Hensing TA, Rowland K, Schiller J, Ding K, Shepherd FA. Gefitinib versus placebo in completely resected non-small-cell lung cancer: results of the NCIC CTG BR19 study. J Clin Oncol. 2013 Sep 20;31(27):3320-6. doi: 10.1200/JCO.2013.51.1816. Epub 2013 Aug 26.

  PMID: 23980091 BACKGROUND

• Li N, Ou W, Ye X, Sun HB, Zhang L, Fang Q, Zhang SL, Wang BX, Wang SY. Pemetrexed-carboplatin adjuvant chemotherapy with or without gefitinib in resected stage IIIA-N2 non-small cell lung cancer harbouring EGFR mutations: a randomized, phase II study. Ann Surg Oncol. 2014 Jun;21(6):2091-6. doi: 10.1245/s10434-014-3586-9. Epub 2014 Mar 1.

  PMID: 24585406 BACKGROUND

Study Officials

• Lunxu Liu, Professor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 18, 2015
• Study Start: November 11, 2015
• Primary Completion: June 7, 2016
• Study Completion: June 7, 2016
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

CN (1)