A Randomized, Double-Blind, Multicenter, Phase Ⅲ Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
| Registry | NCT04073537 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 386 (Estimated) |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry) |
| Conditions | Squamous Non-small Cell Lung Cancer |
| Interventions | Anlotinib, Placebos, Paclitaxel, Carboplatin (Drug) |
| Dates | start 2019-10-31 (estimated), primary completion 2021-07-31 (estimated), completion 2022-06-30 (estimated), first posted 2019-08-29, last updated 2019-08-29 |
| Locations | 2 sites in China |
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All trials for Squamous Non-small Cell Lung Cancer All trials of Anlotinib All trials of Placebos
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental group | Experimental | Drug: Anlotinib; Drug: Paclitaxel; Drug: 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 | Placebo comparator | Drug: Placebos; Drug: Paclitaxel; Drug: 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. |
Sex: All, ages: 18 Years to 75 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing, Beijing Municipality | China | |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang, Hebei | China |