NSCLCNCT02526537
Gefitinib for EGFR Sensitive Mutation Postoperative Stage Ib NSCLC Patients
An observational study of NSCLC, run by Lunxu Liu at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- NSCLC
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2015to 7 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NSCLC patients received complete resection at stage Ib with deletion of exon 19 or mutation of L858R at exon 21 in EGFR
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
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- 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;
- Patients with serious active infections;
- Patients with T790M mutations at 20 exon;
- Woman who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- NSCLC
- Keywords
- Gefitinib, NSCLC, postoperative, stage Ib, Relapse Free Survival in 2 years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Free Survival in 2 years
Measured: Treatment period: 2 years (24 months)
Secondary outcomes (3)
Relapse Free Survival in 3 years
Measured: Follow-up: 3 years
5 year Overall Survival
Measured: Follow-up: 5 years
Relapse Free Survival in 5 years
Measured: Follow-up: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start11 Nov 2015
- Primary completion7 Jun 2016
- Study completion7 Jun 2016
Why it stopped: Similar study has revealed result of no benefit for participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lunxu Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lunxu Liu, West China Hospital
- Investigators
- Lunxu Liu, Professor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526537
- Sponsor's protocol ID
- TSCI001
- Status last verified
- Dec 2017
- First submitted
- 11 Aug 2015
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17473659Strauss 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.
PubMed 18809614D'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.
PubMed 23154553Tsuboi 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.
PubMed 16222155Janjigian 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.
PubMed 21150674Zhang 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.
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.
PubMed 23980091Li 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.
PubMed 24585406
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02526537
- Acronym / sponsor ID
- TSCI001
- Conditions
- NSCLC
- Keywords
- Gefitinib, NSCLC, postoperative, stage Ib, Relapse Free Survival in 2 years
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Similar study has revealed result of no benefit for participants
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lunxu LiuUniversity, hospital or other
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 7 Jun 2016 (actual)
- Study completion
- 7 Jun 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients received complete resection at stage Ib with deletion of exon 19 or mutation of L858R at exon 21 in EGFR
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse Free Survival in 2 years
Time frame: Treatment period: 2 years (24 months)
3 secondary outcomes
Relapse Free Survival in 3 years
Time frame: Follow-up: 3 years
5 year Overall Survival
Time frame: Follow-up: 5 years
Relapse Free Survival in 5 years
Time frame: Follow-up: 5 years
Results and safety
The study was stopped early (reason given: Similar study has revealed result of no benefit for participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Background: PubMed 17473659Wu 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.
- Background: PubMed 18809614Strauss 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.
- Background: PubMed 23154553D'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.
- Background: PubMed 16222155Tsuboi 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.
- Background: PubMed 21150674Janjigian 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.
- BackgroundZhang 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: PubMed 23980091Goss 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.
- Background: PubMed 24585406Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lunxu Liu, Professor principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Lunxu Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Similar study has revealed result of no benefit for participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Free Survival in 2 years (time frame: Treatment period: 2 years (24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526537, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.