This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients

Haihe Biopharma Co., Ltd.313 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

313

Conditions

Extensive-stage Small Cell Lung Cancer

Interventions

AL3810DRUG

5mgQD, 7.5mgQD, 10mgQD

carboplatin + etoposideDRUG

Carboplatin and etoposide are background treatment.

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 exclusion criteria * Histologically confirmed mixed small cell lung cancer. * Symptoms related to central nervous system(CNS) metastasis, unstable CNS metastasis, or CNS diseases needed the increase of steroid dosage to control. * Uncontrolled hypertension.

Locations (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Phase II:adverse event(AE)/serious adverse event(SAE)

AE/SAE to find the recommended dose of AL3810

Time frame: 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

Phase III:1.PFS

1\. Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1

Time frame: 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

Central Contacts

Yixing Chen

CONTACT

+ 86-(021)-2056 8989 yixing.chen@haihepharma.com

Data from ClinicalTrials.gov

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