Squamous Non-small Cell Lung Cancer
Conditions
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.
Interventions
DRUGAnlotinib
A multi-target receptor tyrosine kinase inhibitor.
DRUGPlacebos
Anlotinib blank analog capsule.
DRUGPaclitaxel
Paclitaxel 175 mg/m\^2 IV on Day 1 of each 21-day cycle.
DRUGCarboplatin
Carboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Squamous non-small cell lung cancer. 2. A measurable lesion. 3. 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.
Exclusion criteria
1. The tumor invades the large blood vessels. 2. Central type squamous non-small cell lung cancer. 3. EGFR/ALK gene mutation is positive. 4. Has used EGFR inhibitors and ALK inhibitors. 5. Has other malignant tumors within 5 years. 6. Has a variety of factors affecting oral medications. 7. Symptomatic brain metastasis. 8. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage. 9. Spinal cord compression. 10. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization. 11. Severe allergies to therapeutic medications. 12. Adverse events caused by previous treatment did not recover to grade 1. 13. Has received major surgical treatment within 4 weeks before randomization. 14. Arteriovenous thrombosis occurred within 6 months. 15. Has drug abuse history that unable to abstain from or mental disorders. 16. Has severe or uncontrolled disease. 17. Participated in other clinical trials within 4 weeks. 18. According to the investigators' judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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 |
| Serious Adverse Event (SAE) | up to 24 months | Safety data |
| Abnormal laboratory test index | up to 24 months | Safety data |
| OS rate at month 6 | up to 6 months | The percentage of OS at month 6. |
Countries
China
Contacts
Primary ContactYuankai Shi, Doctor
Outcome results
None listed