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

Phase 2

• Conditions: Extensive-stage Small Cell Lung Cancer
• Interventions: Drug: AL3810; Drug: carboplatin + etoposide; Drug: Placebo

• Registration Number: NCT04254471
• Lead Sponsor: Haihe Biopharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-14
• Status Verified: 2020-01
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-02-03
• Last Update Submitted: 2020-02-03
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2022-05-22
• Study Completion: 2022-11-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 313

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
AL3810+ carboplatin + etoposide	carboplatin + etoposide	Phase III:Participants will receive AL3810(recommended dose will be determined by safety monitoring committee (SMC) in Phase II) orally in combination with carboplatin and etoposide during the Cycles 1-4. Thereafter, participants will receive maintenance AL3810 until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.
Placebo+ carboplatin + etoposide	carboplatin + etoposide	Phase III:Participants will receive placebo orally in combination with carboplatin and etoposide during the induction Cycles 1-4. Thereafter, participants will receive maintenance placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.
Dose escalation (AL3810 + carboplatin + etoposide)	carboplatin + etoposide	Phase II:Participants will receive AL3810 orally in combination with carboplatin and etoposide during the Cycles 1-4 . AL3810 dose escalated form 5mg to 10mg step-up to determine the recommended dose of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
Dose escalation (AL3810 + carboplatin + etoposide)	AL3810	Phase II:Participants will receive AL3810 orally in combination with carboplatin and etoposide during the Cycles 1-4 . AL3810 dose escalated form 5mg to 10mg step-up to determine the recommended dose of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
Placebo+ carboplatin + etoposide	Placebo	Phase III:Participants will receive placebo orally in combination with carboplatin and etoposide during the induction Cycles 1-4. Thereafter, participants will receive maintenance placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.
AL3810+ carboplatin + etoposide	AL3810	Phase III:Participants will receive AL3810(recommended dose will be determined by safety monitoring committee (SMC) in Phase II) orally in combination with carboplatin and etoposide during the Cycles 1-4. Thereafter, participants will receive maintenance AL3810 until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China