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

Extensive-stage Small Cell Lung Cancer Clinical Trial

Official title:

Multicenter, Phase II/III Study of Carboplatin Plus Etoposide With AL3810 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04254471
• Other study ID #: AL3810-301
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 14, 2019
• Est. completion date: November 22, 2022

Study information

• Verified date: January 2020
• Source: ShangHai HaiHe Pharmaceutical
• Contact: Yixing Chen
• Phone: + 86-(021)-2056 8989
• Email: yixing.chen[@]haihepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 313
• Est. completion date: November 22, 2022
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extensive-stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• AL3810
5mgQD, 7.5mgQD, 10mgQD
• carboplatin + etoposide
Carboplatin and etoposide are background treatment.
• Placebo
Placebo

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai HaiHe Pharmaceutical

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase II:adverse event(AE)/serious adverse event(SAE)	AE/SAE to find the recommended dose of AL3810	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
Primary	Phase III:1.PFS	1. Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1	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