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

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-12-31

Brief 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).

Conditions

Advanced Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2928 injection + Almonertinib Mesilate Tablets

Every 3 weeks constitutes one treatment cycle. For the first 2 cycles, TQB2928 is administered via infusion once a week. Starting from the 3rd cycle, TQB2928 is administered once every 3 weeks. Amivantamab is taken orally at a fixed time daily.

Group Type: EXPERIMENTAL

TQB2928 injection + Almonertinib Mesilate Tablets

Intervention Type: DRUG

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.

Interventions

TQB2928 injection + Almonertinib Mesilate Tablets

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Li Zhang, Doctor

Role: CONTACT

Zhangli@syscc.cn

020-87343458

Wenfeng Fang, Doctor

Role: CONTACT

fangwf@sysucc.org.cn

15322302066

Facility Contacts

Li Zhang, Doctor

Role: primary

Zhangli@syscc.cn

020-87343458

Wenfeng Fang, Doctor

Role: backup

fangwf@sysucc.org.cn

15322302066

Other Identifiers

TQB2928-Ib-03

Identifier Type: -

Identifier Source: org_study_id