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

• Status: Recruiting
• Trial end date: 2022-11-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haihe Biopharma Co., Ltd.; ShangHai HaiHe Pharmaceutical
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Rabeprazole

Criteria

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.