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

Primary Purpose

Extensive-stage Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AL3810
carboplatin + etoposide
Placebo
Sponsored by
Haihe Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive-stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dose escalation (AL3810 + carboplatin + etoposide)

AL3810+ carboplatin + etoposide

Placebo+ carboplatin + etoposide

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 16, 2020
Last Updated
February 3, 2020
Sponsor
Haihe Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04254471
Brief Title
This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
May 22, 2022 (Anticipated)
Study Completion Date
November 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haihe Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive-stage Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
313 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation (AL3810 + carboplatin + etoposide)
Arm Type
Experimental
Arm Description
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.
Arm Title
AL3810+ carboplatin + etoposide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo+ carboplatin + etoposide
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AL3810
Other Intervention Name(s)
Lucitanib, E3810, E-3810
Intervention Description
5mgQD, 7.5mgQD, 10mgQD
Intervention Type
Drug
Intervention Name(s)
carboplatin + etoposide
Intervention Description
Carboplatin and etoposide are background treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Phase II:adverse event(AE)/serious adverse event(SAE)
Description
AE/SAE to find the recommended dose of AL3810
Time Frame
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
Title
Phase III:1.PFS
Description
1. Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
Time Frame
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

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yixing Chen
Phone
+ 86-(021)-2056 8989
Ext
8903
Email
yixing.chen@haihepharma.com
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baohui Han, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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