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

NCT04254471 | Unknown Phase 2

• 1 other identifier: AL3810-301
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

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.

Conditions

Extensive-stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Dose escalation (AL3810 + carboplatin + etoposide)

EXPERIMENTAL

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.

Drug: AL3810; Drug: carboplatin + etoposide

AL3810+ carboplatin + etoposide

EXPERIMENTAL

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.

Drug: AL3810; Drug: carboplatin + etoposide

Placebo+ carboplatin + etoposide

PLACEBO COMPARATOR

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.

Drug: carboplatin + etoposide; Drug: Placebo

Interventions

AL3810 DRUG

5mgQD, 7.5mgQD, 10mgQD

Also known as: Lucitanib, E3810, E-3810

AL3810+ carboplatin + etoposide; Dose escalation (AL3810 + carboplatin + etoposide)

carboplatin + etoposide DRUG

Carboplatin and etoposide are background treatment.

AL3810+ carboplatin + etoposide; Dose escalation (AL3810 + carboplatin + etoposide); Placebo+ carboplatin + etoposide

Placebo DRUG

Placebo

Placebo+ carboplatin + etoposide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haihe Biopharma Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Rabeprazole; E-3810; EC regimen

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Yixing Chen

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: February 5, 2020
• Study Start: November 14, 2019
• Primary Completion: May 22, 2022
• Study Completion: November 22, 2022
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

CN (1)