Clinical trial NCT03376191: Apatinib in Advanced Non-squamous，NSCLC
Official title: Prospective, Multicenter, Non-intervention Clinical Trial of Apatinib in the Treatment of Advanced Non-squamous，Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-squamous Non-Small Cell Lung Cancer
Keywords: Apatinib
lung cancer
angiogenesis inhibitors
efficacy
safety
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Harbin Medical University
name: Peking University Third Hospital
name: Peking University First Hospital
First posted: 2017-12-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Local advanced or advanced non-squamous non-small cell lung cancer patients

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).

Eligibility criteria: 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.

Primary outcomes:
measure: PFS (Progression-Free survival)
timeFrame: From the date Into this study (signed ICF) to tumor progression or death for any reason，whichever came first, assessed up to 36 months
Secondary outcomes:
measure: OS (Overall survival)
timeFrame: From the date Into this study (signed ICF) to death for any reason，assessed up to 60 months.
measure: DCR (Disease control rate)
timeFrame: From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.
measure: ORR (Objective control rate)
timeFrame: From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.
Other outcomes:
measure: AE (Adverse events)
timeFrame: 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.
measure: SAE (Severe adverse events)
timeFrame: 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.
measure: QOL scores
timeFrame: From the date Into this study (signed ICF) to tumor progression, exit this research, or death，whichever came first, assessed up to 36 months.
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
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