Non-squamous Non-Small Cell Lung Cancer
Conditions
Keywords
Apatinib, lung cancer, angiogenesis inhibitors, efficacy, safety
Brief summary
To explore the efficacy and safety of apatinib in non-squamous non-small cell lung cancer in the real-world.
Detailed description
This is a multi-center, non-interventional clinical study. The number of patients that planned to be recruited is: from May 2017 to April 2019, the actual number of cases recruited into this study. If the clinicians thought the patient is suitable to take apatinib treatment, and give the patient apatinib treatment, the patient can be recruited into this study. Clinicians chose the initial dose of apatinib according to the patient's physical condition. Besides the clinicians adjusted the dose according to the patient's tolerance during the medication. The dosage was demanded not higher than 750 milligram (mg) per day. The patients received apatinib continuously, 28 days for a period, until intolerance, no longer getting benefits or patient wanted stop. During the course of the study, the researchers will not intervene the treatment of the patients, but only record the efficacy and adverse reactions. Main evaluation criteria: PFS Secondary evaluation criteria: OS,DCR and ORR (according to RECIST1.1). Main safety indicators：AE, SAE (according to NCI CTCAE V4.0) and QOL scores (Quality of Life Questionnaire-lung cancer).
Interventions
DRUGapatinib
Clinicians chose the initial dose of apatinib according to the patient's physical condition. Besides the clinicians adjusted the dose according to the patient's tolerance during the medication.The dosage was demanded not higher than 750 milligram (mg) per day. The patients received apatinib continuously, 28 days for a period, until intolerance, no longer getting benefits or patient wanted stop.
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Peking University Third Hospital
Peking University First Hospital
Jian Fang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: ≥ 18 years old; 2. Histologically or cytologically confirmed, locally advanced or stage IV non-squamous, non-small cell lung cancer; 3. Regardless of the past anti-tumor treatments (no limited to the number of past treatment lines), the doctors believe that apatinib can bring benefits to patients; 4. The patient is voluntarily to join the study, and signed informed consent, good compliance, with follow-up.
Exclusion criteria
If any of the following criteria is met, the subject shall be excluded: 1. Squamous cell carcinoma and/or small cell lung cancer patients; 2. There are contraindications to apatinib (active bleeding, thrombosis, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade III-IV cardiac insufficiency, major surgery within 30 days, severe liver and kidney dysfunction, etc.); 3. Allergic to apatinib and / or its excipients; 4. Pregnant or lactating women; 5. According to the researcher's judgment, there are other situations that may increase the risk associated with participating in this study or the drug, which may lead to patients not being eligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS (Progression-Free survival) | From the date Into this study (signed ICF) to tumor progression or death for any reason，whichever came first, assessed up to 36 months | From the date Into this study (signed ICF) to tumor progression or death for any reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR (Disease control rate) | From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months. | The rate of CR, PR plus SD |
| ORR (Objective control rate) | From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months. | The rate of CR and PR |
| OS (Overall survival) | From the date Into this study (signed ICF) to death for any reason，assessed up to 60 months. | From the date Into this study (signed ICF) to death for any reason. |
Other
| Measure | Time frame | Description |
|---|---|---|
| AE (Adverse events) | From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death，whichever came first, assessed up to 36 months. | AE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0). |
| SAE (Severe adverse events) | From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death，whichever came first, assessed up to 36 months. | SAE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0). |
| QOL scores | From the date Into this study (signed ICF) to tumor progression, exit this research, or death，whichever came first, assessed up to 36 months. | Quality of life scores |
Countries
China
Outcome results
None listed