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The purpose of this study is to evaluate the efficacy and safety of apatinib plus EGFR-TKI as first line treatment in patients with non-squamous NSCLC harboring EGFR mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib | Experimental | apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Baseline to measured date of progression or death from any cause | evaluated in two years since the treatment began |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Baseline to measured stable disease | tumor assessment every 8 weeks,up to two years |
| Disease control rate (DCR) | Baseline to measured progressive disease |
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Inclusion Criteria:
Age:18 to 75 years old (man or female);
Pathologically diagnosed with non-squamous NSCLC;
Imageology diagnosed with locally advanced/metastatic or recurrent (stage ⅢB - IV);
Histologically or cytologic confirmed,harboring an activating EGFR mutation (19del or 21 L858R);
None previous chemotherapy or targeted therapy.(NOTE: neoadjuvant and adjuvant therapy is allowed);
At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Major organ function has to meet the following criteria:
Life expectancy greater than or equal to 3 months;
Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junfeng Liu, Professor | Contact | 13931152296 | 13931152296@126.com | |
| Junfeng Liu | Contact | 13931152296 | 13931152296@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Junfeng Liu | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Junfeng Liu | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| tumor assessment every 8 weeks,up to two years |
| Overall survival (OS) | Baseline to measured date of death from any cause | the first day of treatment to death or last survival confirm date,up to two years |
| Adverse events | throughout study | evaluated in the two years since the treatment began according to the Common Terminology Criteria for Adverse Events Version 4.0 |