APatinib Plus Chemotherapy vErsus Chemotherapy As First-line Treatment for Advanced NSCLC (APPEAL)
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|ClinicalTrials.gov Identifier: NCT03164694|
Recruitment Status : Unknown
Verified July 2018 by Si-Yu Wang, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : May 24, 2017
Last Update Posted : July 30, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Apatinib Drug: Pemetrexed Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase II Trial of Pemetrexed Plus Carboplatin With or Without Apatinib in Patients With Advanced Non-small Cell Lung Cancer Without EGFR Mutation, ALK Gene Rearrangement, and ROS1 Gene Rearrangement|
|Actual Study Start Date :||May 20, 2017|
|Estimated Primary Completion Date :||May 20, 2019|
|Estimated Study Completion Date :||May 20, 2020|
Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5) plus apatinib. Apatinib was given 850 mg per day orally at day one of chemotherapy.
Apatinib was given 850 mg per day orally.
pemetrexed (500 mg/m2)
carboplatin (AUC =5)
Active Comparator: Control
Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5).
pemetrexed (500 mg/m2)
carboplatin (AUC =5)
- Overall survival [ Time Frame: 1 year after the last patient is randomized ]Overall survival was assessed from randomization to death as a result of any cause.
- Disease-free survival [ Time Frame: 1 year after the last patient is randomized ]Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
- Number of Participants with Adverse Events [ Time Frame: 1 year ]To assess if the addition of apatinib to chemotherapy is safe.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Target population is advanced NSCLC (IIIB-IV) without EGFR mutation, ALK gene rearrangement, and ROS1 gene rearrangement.
- Written informed consent provided.
- Male and female patients aged ≥18 years, < 75 years.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Life expectancy ≥12 weeks.
- Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
- Female subjects should not be pregnant or breast-feeding.
- Known severe hypersensitivity to apatinib or any of the excipients of this product.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
- Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
- Patients with prior radiotherapy
- History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
- Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)
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): NCT03164694
|Contact: Si-Yu Wang, MD||+86 20 email@example.com|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Si-Yu Wang, Doctor +86 20 87343439 firstname.lastname@example.org|
|Responsible Party:||Si-Yu Wang, Professor, Sun Yat-sen University|
|Other Study ID Numbers:||
|First Posted:||May 24, 2017 Key Record Dates|
|Last Update Posted:||July 30, 2018|
|Last Verified:||July 2018|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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