Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to determine whether apatinib plus chemotherapy drug can improve progression free survival compared with chemotherapy drug in patients with metastatic the non-small cell lung cancer who failed one lines of chemotherapy.
Terminated
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Apatinib/docetaxel/pemetrexed | Apatinib+docetaxel/pemetrexed | |
| docetaxel/pemetrexed | docetaxel/pemetrexed |
Lung cancer is the leading cause of cancer death in world wild, especially non-small cell
lung cancer (NSCLC). Detection and early intervention are difficult because pathogenesis of
NSCLC is not yet entirely clear.Most of them are advanced or metastatic patients, so approach
3/4 NSCLC undergo chemotherapy. Fewer treatment options exist on NSCLC whom is wild type of
EGFR. The patient did not benefit from the existing treatment regimen after first-line
treatment. There is currently no effective drug to treat this group of patients.
Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor
activity in the patients with GC. The purpose of this study is to determine whether apatinib
plus chemotherapy drug can improve progression free survival compared with chemotherapy drug
in patients with metastatic the non-small cell lung cancer who failed one lines of
chemotherapy.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Apatinib+docetaxel/pemetrexed | Experimental | Apatinib 500mg QD PO d1-21+docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d |
|
| docetaxel/pemetrexed | Active Comparator | docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d |
|
Inclusion Criteria:
1. Age：18~75 years;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Subjects with histologically or cytologically confirmed locally advanced or advanced
NSCLC who have previously received no more than one lines treatment before
participating；
4. Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which
is confirmed by computed tomography (CT) scan or MRI .
5. EGFRˉ,and ALK mutation in the negative or unknown；
6. Subjects without brain metastases or asymptomatic brain metastases, and not needing
for dehydrating agents or corticosteroids to control intracranial symptoms;
7. Survival expectation≥ 3 months;
8. The main organ function is normal;
9. Females of childbearing potential must be a pregnancy test in 7 days before
participating ( including serum or urine), and the results were negative.
10. Subjects provided written informed consent before participating,Willing and able to
comply with all aspects of the protocol
Exclusion Criteria:
1. Small Cell Lung Cancer;
2. Subjects with symptomatic brain metastases;
3. Survival expectation < 3 months;
4. Blood transfusion is required in the first dose of drug treatment within 14 days ;
5. The interval of subjects had received chemotherapy, biotherapy, radiotherapy or other
anticancer therapies in the first dose of drug treatment within 21 days(excluding
palliative radiotherapy);
6. The risk of active bleeding;
7. Subjects with uncontrolled blood pressure with medication (140/90 mmHg)
8. Laboratory values and organ functions ： （1）Hematologic insufficiency:
1. Hemoglobin (Hb)<8.5 g/dL，
2. Absolute neutrophil count (ANC)≤1.5×109/L，
3. Platelet count (PLT)< 100×109/L； （2）Insufficient liver function:
1. Bilirubin > 1.5×the upper limit of normal (ULN)
2. Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) >3.0×(ULN),
When liver metastases,Bilirubin > 1.5×ULN, ALT or AST >5.0×(ULN.
3. serum creatinine ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per
the Cockcroft and Gault formula) (3) Subjects with positive for HBV
surfaceantigen ( HBsAg)or anti-hcv (4)Subjects with Interstitial lung disease
(5)Insufficient renal function: serum creatinine≥ 1.5×（ULN）, or creatinine
clearance <60 mL/min
9. impairment of heart function: (1)Left ventricular ejection fraction (LVEF) <45% (LVEF
evaluation is not required for subjects have no history of congestive heart failure),
(2)Unstable angina, (3)Severe arrhythmia, (4)NYHA III or IVgrade of congestive heart
failure, (5) Subjects with miocardial infarction within the last 12 months before
entering the trial, (6)Pericardial effusion,
10. Subjects with liver fibrosis or hepatic cirrhosis
11. (1)Subjects with other active malignancy (except for definitively treated non melanoma
skin cancer,carcinoma in-situ of the cervix,or other cancers that are treated with
curative treatment and have no signs of recurrence for at least 5 years ) ,
(2)Subjects with dysphagia,malabsorption,chronic gastrointestinal diseases,or other
medical history may hinder compliance and / or experimental drug absorption,
12. Subjects with major surgery in the first dose of drug treatment within 28 days,
13. Subjects with positive foknown human immunodeficiency virus。
| Maximum Eligible Age: | 75 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | progression-free survival |
| Time Frame: | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months |
| Safety Issue: | |
| Description: | To compare progression-free survival (PFS) in subjects treated with apatinib plus chemotherapy drug versus chemotherapy drug as a second-line treatment in whom with advanced or metastatic non-small cell lung cancer (NSCLC) |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Fuzhou General Hospital |
February 8, 2021
