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Gefitinib for EGFR Sensitive Mutation Postoperative Stage Ib NSCLC Patients

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ClinicalTrials.gov Identifier: NCT02526537
Recruitment Status : Terminated (Similar study has revealed result of no benefit for participants)
First Posted : August 18, 2015
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Lunxu Liu, West China Hospital, Sichuan University

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.

Condition or disease
NSCLC

Detailed Description:

Currently, whether adjuvant therapy should be applied to Stage Ib non-small cell lung cancer (NSCLC) patients who received radical resection remains controversial. CALGB9633 studies have shown that for patients with stage Ib NSCLC who received radical resection, postoperative adjuvant chemotherapy does not benefit for all patients, only patients with high risk (cancer diameter >4cm) can benefit. 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.

The EGFR gene mutation rate is about 10% for European patients, and about 30-40% for patients of Asian origins. In a retrospective observation study of 1118 stage I to stage III NSCLC patients who received surgery, D'Angelo et al. found that the risk of death for patients with EGFR sensitive mutation is lower than those without mutation. The authors indicated that postoperative use of TKI for EGFR sensitive mutation patients might be the possible reason. Since the mutation rate of EGRF gene is higher in Asian patients, compared with patients of other origins, the investigators speculate that Asian patients might benefit for postoperative use of TKIs.

EGFR gene mutation detection is routinely prescribed nowadays for lung adenocarcinoma patients who received surgical resection. According to NCCN guideline, stage IB patients with high risk factors are recommended to receive adjuvant chemotherapy. For patients who can not tolerate or decline chemotherapy, non-specific treatment ( Chinese herbal medicine and nonspecific immunomodulators as adjuvant anti-cancer treatment for 2 years) is recommended, otherwise, TKIs(Gefitinib 250 mg daily for 2 years) is also an alternative choice if the cancer has EGFR sensitive mutation. Based on patient's own choice of postoperative adjuvant therapy , the patients were enrolled for observation of prognosis.


Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Postoperative Adjuvant Therapy of Gefitinib for High Risk Stage Ib NSCLC Patients With EGFR Sensitive Mutation, an Open, Paired, Non-interventional, Multi-center Clinical Study
Actual Study Start Date : November 11, 2015
Actual Primary Completion Date : June 7, 2016
Actual Study Completion Date : June 7, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Gefitinib
U.S. FDA Resources

Group/Cohort
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).



Primary Outcome Measures :
  1. Relapse Free Survival in 2 years [ Time Frame: Treatment period: 2 years (24 months) ]

Secondary Outcome Measures :
  1. Relapse Free Survival in 3 years [ Time Frame: Follow-up: 3 years ]
  2. 5 year Overall Survival [ Time Frame: Follow-up: 5 years ]
  3. Relapse Free Survival in 5 years [ Time Frame: Follow-up: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  1. 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.
  2. Patients with pathology confirmed Ib stage NSCLC
  3. Patients with deletion of exon 19 or mutation of L858R at exon 21 in EGFR gene
  4. ECOG score of 0-1
  5. Life expectancy over 12 weeks
  6. Absolute neutrophil count (ANC) >= 1.75 x 109 / L, platelet >= 100 x 109 / L, hemoglobin is more than or equal to 9 g / dl
  7. 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)
  8. Serum creatinine <=1.25 times of the upper limit of normal value, creatinine clearance rate > 60 or ml/min
  9. received the informed consent from patient or his/her legal representative

Exclusion Criteria:

  1. Patients who was serious allergy to any of the ingredients of drugs used in this study
  2. Patients who unable to comply with the study plan or research program;
  3. Patients with severe systemic disease that the researchers judged will be unable to complete the study;
  4. Patients have severe heart disease, such as myocardial infarction within 6 months;
  5. Patients have interstitial pneumonia;
  6. Patients who were confirmed to be positive pathology for cutting edge;
  7. The preoperative chest CT showed nodules >= 50%, and showed ground glass opacity;
  8. Patients received wedge resection;
  9. Patients used HER2 pathways involved drugs such as erlotinib, gefitinib, cetuximab rituximab, trastuzumab)
  10. Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy);
  11. Patients received radiotherapy;
  12. 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;
  13. 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).
  14. Patients who do not get effective treatment of inflammation, eye infections or predisposing factors;
  15. Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study;
  16. Patients with serious active infections;
  17. Patients with T790M mutations at 20 exon;
  18. Woman who are pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526537


Locations
China, Sichuan
West China Hospital
ChengDu, Sichuan, China
Sponsors and Collaborators
Lunxu Liu
Investigators
Principal Investigator: Lunxu Liu, Professor West China Hospital

Publications:
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.

Responsible Party: Lunxu Liu, chief physician, West China Hospital, Sichuan University
ClinicalTrials.gov Identifier: NCT02526537     History of Changes
Other Study ID Numbers: TSCI001
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Keywords provided by Lunxu Liu, West China Hospital, Sichuan University:
Gefitinib
NSCLC
postoperative
stage Ib
Relapse Free Survival in 2 years

Additional relevant MeSH terms:
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action