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Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy.

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules
TQB2450 matching placebo, docetaxel injection, AL2846 matching placebo
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Age: 18-75 years; Eastern Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; BMI ≥ 17 at baseline; Patients with histologically or cytologically confirmed inoperable and inoperable locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) nonsmall-cell lung cancer (NSCLC) who cannot receive radical concurrent chemoradiotherapy; Failure of platinum-based chemotherapy and immune checkpoint inhibitors for incurable locally advanced or metastatic or recurrent NSCLC; Number of lines of prior systemic therapy received for locally advanced or metastatic/recurrent disease that is unresectable/not amenable to radical chemoradiation; Adequate major organ function; Exclusion Criteria: Patients who had or currently had other malignant tumors within 3 years; Presence of:epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, c-ros oncogene 1 (ROS1) fusion and other significant driver gene mutations; Factors affecting oral drugs; Major surgical treatment, incisional biopsy or obvious traumatic injury and long-term uncured wound or fracture within 28 days before the start of study treatment; Hyperactive/venous thrombotic events within 6 months; Subjects with any severe and/or uncontrolled disease; Previously received other immunotherapy and Research Advance of Small Molecular Targeted Anti-Tumor Agents Tyrosine kinase inhibitors (TKIs); According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or there are other reasons that are not suitable for the subject;

Sites / Locations

  • Peking University First HospitalRecruiting
  • Chinese PLA General HospitalRecruiting
  • TianJin Medical University Cancer Institute & HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules

TQB2450 matching placebo + docetaxel injection + AL2846 matching placebo

Arm Description

TQB2450 injection combined with docetaxel injection matching placebo and AL2846 capsules 21 days as a treatment cycle.

TQB2450 matching placebo combined with docetaxel injection and AL2846 matching placebo 21 days as a treatment cycle.

Outcomes

Primary Outcome Measures

Overall survival (OS)
The time from randomization to the date of death from any cause.

Secondary Outcome Measures

Progression-free survival (PFS) by investigator assessment
Time from randomization to objective disease progression or death from any cause, whichever occurs first.
Objective response rate (ORR)
Refers to the percentage of subjects with complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Disease Control Rate (DCR)
Refers to the percentage of subjects with complete response (CR), partial response (PR) or stable disease (SD) ≥ 6 weeks as determined by the investigator according to RECIST 1.1.
Duration of response (DOR)
For subjects with a best response of complete response (CR) or partial response (PR), it is defined as the time from the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first.
12-month survival rate (12-month OS rate)
The survival curve corresponds to the cumulative survival rate at 12 months
Health Questionnaire Form
Questionnaire: pain score:Place a check in the space that best reflects patients' health for the day.
Effects on subjects' health-related quality of life
Questionnaire: Quality of life related scale (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 3rd edition).For questions 1 to 28, choose a number from 1 to 4, 1 means none and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, with 1 being very poor and 7 being very good.
Patients with abnormal laboratory inspection indicators
Laboratory inspection indicators exceed the normal range
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Occurrence of anti-drug antibody (ADA)
Occurrence of ADA immunoglobulin
Occurrence of neutralizing antibody (Nab)
Antibody preventing cells from being invaded by an antigen or infectious agent.

Full Information

First Posted
June 6, 2023
Last Updated
June 19, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05922345
Brief Title
Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy.
Official Title
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsules Combined With TQB2450 Injection Compared With Docetaxel Injection in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed With Immunotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
To investigate the efficacy of AL2846 capsules in combination with TQB2450 injection or Docetaxel injection in patients with advanced NSCLC who have previously failed immune checkpoint inhibitors (anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody), regardless of new anti-tumor treatment and early termination of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
518 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules
Arm Type
Experimental
Arm Description
TQB2450 injection combined with docetaxel injection matching placebo and AL2846 capsules 21 days as a treatment cycle.
Arm Title
TQB2450 matching placebo + docetaxel injection + AL2846 matching placebo
Arm Type
Active Comparator
Arm Description
TQB2450 matching placebo combined with docetaxel injection and AL2846 matching placebo 21 days as a treatment cycle.
Intervention Type
Drug
Intervention Name(s)
TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules
Intervention Description
AL2846 capsules is a multi-targeted small molecule receptor tyrosine kinase inhibitor. TQB2450 Injection is an anti-programmed death-1 (PD-L1).
Intervention Type
Drug
Intervention Name(s)
TQB2450 matching placebo, docetaxel injection, AL2846 matching placebo
Intervention Description
Docetaxel injection is a type of chemotherapy for treatment of different types of cancer.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
The time from randomization to the date of death from any cause.
Time Frame
From randomization to the time of death from any cause, assessed up to 36 months.
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS) by investigator assessment
Description
Time from randomization to objective disease progression or death from any cause, whichever occurs first.
Time Frame
From the date of randomization to the date of first recorded progression or death from any cause, whichever comes first, assessed up to 36 months.
Title
Objective response rate (ORR)
Description
Refers to the percentage of subjects with complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Time Frame
Time from the date of randomization to the first recorded complete remission (CR) or partial remission (PR), assessed up to 36 months.
Title
Disease Control Rate (DCR)
Description
Refers to the percentage of subjects with complete response (CR), partial response (PR) or stable disease (SD) ≥ 6 weeks as determined by the investigator according to RECIST 1.1.
Time Frame
Baseline up to CR or PR or 6 weeks, whichever came first.
Title
Duration of response (DOR)
Description
For subjects with a best response of complete response (CR) or partial response (PR), it is defined as the time from the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first.
Time Frame
From the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first, assessed up to 36 months.
Title
12-month survival rate (12-month OS rate)
Description
The survival curve corresponds to the cumulative survival rate at 12 months
Time Frame
Baseline up to 12-month
Title
Health Questionnaire Form
Description
Questionnaire: pain score:Place a check in the space that best reflects patients' health for the day.
Time Frame
During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.
Title
Effects on subjects' health-related quality of life
Description
Questionnaire: Quality of life related scale (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 3rd edition).For questions 1 to 28, choose a number from 1 to 4, 1 means none and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, with 1 being very poor and 7 being very good.
Time Frame
During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.
Title
Patients with abnormal laboratory inspection indicators
Description
Laboratory inspection indicators exceed the normal range
Time Frame
From signing the informed consent form to the 30 days after the last dose.
Title
Adverse event rate
Description
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time Frame
From signing the informed consent form to the 30 days after the last dose.
Title
Occurrence of anti-drug antibody (ADA)
Description
Occurrence of ADA immunoglobulin
Time Frame
Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.
Title
Occurrence of neutralizing antibody (Nab)
Description
Antibody preventing cells from being invaded by an antigen or infectious agent.
Time Frame
Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-75 years; Eastern Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; BMI ≥ 17 at baseline; Patients with histologically or cytologically confirmed inoperable and inoperable locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) nonsmall-cell lung cancer (NSCLC) who cannot receive radical concurrent chemoradiotherapy; Failure of platinum-based chemotherapy and immune checkpoint inhibitors for incurable locally advanced or metastatic or recurrent NSCLC; Number of lines of prior systemic therapy received for locally advanced or metastatic/recurrent disease that is unresectable/not amenable to radical chemoradiation; Adequate major organ function; Exclusion Criteria: Patients who had or currently had other malignant tumors within 3 years; Presence of:epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, c-ros oncogene 1 (ROS1) fusion and other significant driver gene mutations; Factors affecting oral drugs; Major surgical treatment, incisional biopsy or obvious traumatic injury and long-term uncured wound or fracture within 28 days before the start of study treatment; Hyperactive/venous thrombotic events within 6 months; Subjects with any severe and/or uncontrolled disease; Previously received other immunotherapy and Research Advance of Small Molecular Targeted Anti-Tumor Agents Tyrosine kinase inhibitors (TKIs); According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or there are other reasons that are not suitable for the subject;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dingzhi Huang, Doctor of Medicine
Phone
+86 18622221232
Email
dingzhi72@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Hu, Doctor of Medicine
Phone
+86 13911031186
Email
huyi0401@aliyun.com
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ligong Nie, Master
Phone
+86 13910714307
Email
nieligong@sina.com
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Hu, M.D
Phone
+86 13911031189
Email
huyi0401@aliyun.com
Facility Name
TianJin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingzhi Huang, M.D
Phone
+86 18622221232
Email
dingzhi72@163.com

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy.

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