Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
- Conditions
- Squamous Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT04073537
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 386
- Squamous non-small cell lung cancer.
- A measurable lesion.
- The disease progression occurs >12 months after the end of the last treatment. 4.18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.
- The tumor invades the large blood vessels.
- Central type squamous non-small cell lung cancer.
- EGFR/ALK gene mutation is positive.
- Has used EGFR inhibitors and ALK inhibitors.
- Has other malignant tumors within 5 years.
- Has a variety of factors affecting oral medications.
- Symptomatic brain metastasis.
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- Spinal cord compression.
- Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
- Severe allergies to therapeutic medications.
- Adverse events caused by previous treatment did not recover to grade 1.
- Has received major surgical treatment within 4 weeks before randomization.
- Arteriovenous thrombosis occurred within 6 months.
- Has drug abuse history that unable to abstain from or mental disorders.
- Has severe or uncontrolled disease.
- Participated in other clinical trials within 4 weeks.
- According to the investigators' judgement.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebos Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m\^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. Experimental group Anlotinib Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. Experimental group Paclitaxel Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. Experimental group Carboplatin Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. Placebo group Carboplatin Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m\^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. Placebo group Paclitaxel Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m\^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) evaluated by IRC up to 24 months PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.
- Secondary Outcome Measures
Name Time Method Duration of Overall Response (DOR) up to 24 months The time when the patient first achieved complete or partial remission to disease progression.
PFS rate at month 6 up to 6 months The percentage of PFS at month 6.
PFS rate at month 12 up to 12 months The percentage of PFS at month 12.
Progression Free Survival (PFS) evaluated by investigator up to 24 months PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Overall Survival (OS) up to 24 months OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Overall Response Rate (ORR) up to 24 months Percentage of participants achieving complete response (CR) and partial response (PR).
Disease Control Rate（DCR） up to 24 months Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
OS rate at month 12 up to 12 months The percentage of OS at month 12.
OS rate at month 18 up to 18 months The percentage of OS at month 18.
Adverse Event (AE) up to 24 months Safety data
OS rate at month 6 up to 6 months The percentage of OS at month 6.
Serious Adverse Event (SAE) up to 24 months Safety data
Abnormal laboratory test index up to 24 months Safety data
Trial Locations
- Locations (2)
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China