Extensive-stage Small Cell Lung Cancer
Conditions
Brief 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.
Interventions
DRUGAL3810
5mgQD, 7.5mgQD, 10mgQD
Carboplatin and etoposide are background treatment.
DRUGPlacebo
Placebo
Sponsors
Haihe Biopharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent Form * Male or female, 18 \ 75years of age * Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1 * Histologically or cytologically confirmed ES-SCLC * No prior treatment for ES-SCLC * Measurable disease, as defined by RECIST v1.1 * Adequate hematologic and end organ function. * Serum pregnancy test in screening period for women of childbearing potential should be negative.Except for women who have a history of sterilization or are postmenopausal.Men or woman subjects of reproductive age and their partners must agree to use effective contraception for at least 6 months from the date of signing the Informed Consent Form(ICF) until the last dose of the investigational therapy.
Exclusion criteria
main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase II:adverse event(AE)/serious adverse event(SAE) | From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | AE/SAE to find the recommended dose of AL3810 |
| Phase III:1.PFS | From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 56 months | 1\. Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1 |
Countries
China
Contacts
Primary ContactYixing Chen
Outcome results
None listed