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Trial 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.
NCT ID:
NCT05922345
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules
Description:
AL2846 capsules is a multi-targeted small molecule receptor tyrosine kinase inhibitor.
TQB2450 Injection is an anti-programmed death-1 (PD-L1).
Arm group label:
TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules
Intervention type:
Drug
Intervention name:
TQB2450 matching placebo, docetaxel injection, AL2846 matching placebo
Description:
Docetaxel injection is a type of chemotherapy for treatment of different types of cancer.
Arm group label:
TQB2450 matching placebo + docetaxel injection + AL2846 matching placebo
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Ligong Nie, Master
Phone:
+86 13910714307
Email:
nieligong@sina.com
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100080
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Hu, M.D
Phone:
+86 13911031189
Email:
huyi0401@aliyun.com
Facility:
Name:
TianJin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Dingzhi Huang, M.D
Phone:
+86 18622221232
Email:
dingzhi72@163.com
Start date:
June 8, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05922345
