Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Carboplatin

Etoposide

Etoposide phosphate

Rabeprazole

Enzyme Inhibitors

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

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.

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.

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 and etoposide are background treatment.

carboplatin + etoposide

Placebo

Yixing Chen

Baohui Han, M.D

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.

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

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

AE/SAE to find the recommended dose of AL3810

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

Haihe Biopharma Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients	NCT04254471	Extensive-stage...	AL3810 carboplatin + e... Placebo	18 Years - 75 Years	Haihe Biopharma Co., Ltd.
This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients	NCT04254471	Extensive-stage...	AL3810 carboplatin + e... Placebo	18 Years - 75 Years	Haihe Biopharma Co., Ltd.

Spots Global Cancer Trial Database for al3810

Every month we try and update this database with for al3810 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for al3810

Every month we try and update this database with for al3810 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for al3810 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.