Trials / Unknown
UnknownNCT04254471
This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients
Multicenter, Phase II/III Study of Carboplatin Plus Etoposide With AL3810 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 313 (estimated)
- Sponsor
- Haihe Biopharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Phase II Study is to Evaluate the Safety and tolerability of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC. Phase III Study is to Evaluate the efficacy of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AL3810 | 5mgQD, 7.5mgQD, 10mgQD |
| DRUG | carboplatin + etoposide | Carboplatin and etoposide are background treatment. |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2019-11-14
- Primary completion
- 2022-05-22
- Completion
- 2022-11-22
- First posted
- 2020-02-05
- Last updated
- 2020-02-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04254471. Inclusion in this directory is not an endorsement.