Description:
The purpose of this study is studying icotinib following chemotherapy to see how well it
works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC
harboring EGFR mutation.
Title
- Brief Title: Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation
- Official Title: A Multicenter, Randomized, Phase III Trial of Chemotherapy Followed by 6-month or 12-month Icotinib Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation
Clinical Trial IDs
- ORG STUDY ID:
GASTO1002
- SECONDARY ID:
wsy003
- NCT ID:
NCT01996098
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| 6-month Icotinib | BPI-2009, Conmana | 6-month icotinib |
| 12-month icotinib | BPI-2009, Conmana | 12-month icotinib |
Purpose
The purpose of this study is studying icotinib following chemotherapy to see how well it
works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC
harboring EGFR mutation.
Detailed Description
Adjuvant chemotherapy is recommended for routine use in patients with fully resected stage
IIA-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase
inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung
cancer (NSCLC) with EGFR mutation. Icotinib is a novel EGFR-TKI developed by a group of
Chinese scientists. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to
gefitinib with better safety. In phase II trial, chemotherapy followed by 6-month gefitinib
as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone
in patients with resected stage IIIA-N2 non-small cell lung cancer harboring EGFR mutations.
This study is to studying 6-month or 12-month icotinib following chemotherapy to see how well
it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC
harboring EGFR mutation.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 6-month icotinib | Experimental | Icotinib 125 mg three times daily (375 mg per day) by mouth for 6 months | |
| 12-month icotinib | Experimental | Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months | |
| Chemotherapy alone | No Intervention | No intervention | |
Eligibility Criteria
Inclusion Criteria:
- Written informed consent provided.
- Aged 18-75 years.
- Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
- EGFR activating mutation in exon 19 or 21.
- Had completed four cycles of platinum-based adjuvant chemotherapy.
- Able to start the investigational therapy within 4 weeks after the completion of four
cycles of adjuvant chemotherapy.
- ECOG performance status of 0-1.
- Had a life expectancy of 12 weeks or more.
- Adequate hematological function, adequate liver function and renal function.
- Able to comply with the required protocol and follow-up procedures, and able to
receive oral medications.
- Female patients, except those who are postmenopausal or surgically sterilized, must
have a negative pre-study serum or urine pregnancy test.
Exclusion Criteria:
- Had had previous chemotherapy besides four cycles of adjuvant chemotherapy,
radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib,
cetuximab, trastuzumab).
- Had a history another malignancy in the last 5 years with the exception of cured basal
cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured
epithelial carcinoma of the bladder.
- Any evidence confirmed tumor recurrence before investigational therapy.
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of clinically active interstitial lung disease.
- Eye inflammation not fully controlled or conditions predisposing the subject to this.
- Any unstable systemic disease (including active infection, uncontrolled hypertension,
unstable angina, congestive heart failure, myocardial infarction within the previous 6
months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic
disease).
- Known human immunodeficiency virus (HIV) infection.
- Pregnancy or breast-feeding women.
- Ingredients mixed with small cell lung cancer patients.
- History of neurologic or psychiatric disorders.
| Maximum Eligible Age: | 75 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Disease-Free Survival |
| Time Frame: | 5 years after the last patient is randomized |
| Safety Issue: | |
| Description: | Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause. |
Secondary Outcome Measures
| Measure: | Overall Survival |
| Time Frame: | 5 years after the last patient is randomized |
| Safety Issue: | |
| Description: | Overall survival was assessed from randomization to death as a result of any cause. |
| Measure: | Number of Participants with Adverse Events |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | To assess if the addition of icotinib to chemotherapy is safe. |
| Measure: | Change from baseline in patient reported Lung Cancer Functional Assessment |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire. |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Sun Yat-sen University |
Last Updated
August 28, 2018
