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Trial Title:
Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers
NCT ID:
NCT06585059
Condition:
Advanced Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2928 injection + Almonertinib Mesilate Tablets
Description:
TQB2928 is a recombinant fully humanized Immunoglobulin G4 (IgG4) monoclonal antibody
that can promote tumor cell phagocytosis by macrophages and exert anti-tumor effects.
Almonertinib Mesilate Tablets is a third generation of EGFR-TKI targeting drug.
Arm group label:
TQB2928 injection + Almonertinib Mesilate Tablets
Summary:
This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in
combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung
cancer, and to determine the recommended Phase II dose (RP2CD).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1; Expected
survival of more than 3 months；
- Locally advanced or metastatic NSCLC diagnosed by histology or cytology
- The major organs are functioning well；
- Negative serum pregnancy test within 7 days prior to the first dose and must be a
non-lactating subject, female and male subjects of childbearing potential should
agree to use contraception for the duration of the study and for 6 months after the
end of the study；
- Subjects voluntarily joined this study, signed the informed consent form, and had
good compliance.
Exclusion Criteria:
- Current concomitant presence of other malignancies within 5 years prior to the first
dose;
- Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy;
- Significant surgical treatment, biopsy, or significant traumatic injury within 28
days prior to the first dose;
- Long-term unhealed wounds or fractures;
- Cerebrovascular accident (including transient ischemic attack, intracerebral
hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism
within 6 months prior to the first dose;
- A history of psychotropic drug abuse and cannot be abstained from or have a mental
disorder;
- Subjects with any severe and/or uncontrolled disease;
- History of live attenuated vaccination within 2 weeks prior to the first dose or
planned live attenuated vaccination during the study;
- Previous history of unexplained severe allergies, hypersensitivity to monoclonal
antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2928
injection or excipients in pharmaceutical formulations;
- According to the judgment of the investigator, there are concomitant diseases that
seriously endanger the safety of the patients or affect the completion of the study,
or subjects who are considered to be unsuitable for enrollment for other reasons.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Contact:
Last name:
Li Zhang, Doctor
Phone:
020-87343458
Email:
Zhangli@syscc.cn
Contact backup:
Last name:
Wenfeng Fang, Doctor
Phone:
15322302066
Email:
fangwf@sysucc.org.cn
Start date:
September 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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/NCT06585059
