Trials / Unknown
UnknownNCT04439890
A Efficacy and Safety Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer
A Randomized, Double-blind, Multicenter Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 369 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, multicenter phase III clinical study to evaluate efficacy and safety of anlotinib hydrochloride capsule combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in subjects with advanced non-squamous cell non-small cell lung cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anlotinib hydrochloride capsule | Anlotinib hydrochloride capsule 12mg 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) |
| DRUG | Carboplatin injection | Carboplatin injection AUC 5mg/mL/min, intravenous drip, on Day 1 in 21-day cycle. |
| DRUG | Pemetrexed disodium f Injection | Pemetrexed disodium f Injection 500mg / m2, intravenous drip, on Day 1 in 21-day cycle. |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2019-08-08
- Primary completion
- 2021-06-01
- Completion
- 2021-12-31
- First posted
- 2020-06-19
- Last updated
- 2020-06-19
Locations
59 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04439890. Inclusion in this directory is not an endorsement.