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

A Phase Ib Clinical Study of TQB2928 in Combination With a Third-Generation EGFR TKI in Patients With Advanced Non-Small Cell Lung Cancers

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: TQB2928 injection + Almonertinib Mesilate Tablets

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wenfeng Fang, Doctor; Phone Number: 15322302066; Email: fangwf@sysucc.org.cn
• Study Contact Backup: Name: Li Zhang, Doctor; Phone Number: 020-87343458; Email: Zhangli@syscc.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
      • Contact: Wenfeng Fang, Doctor; Phone Number: 15322302066; Email: fangwf@sysucc.org.cn
      • Contact: Li Zhang, Doctor; Phone Number: 020-87343458; Email: Zhangli@syscc.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	Defined as the time from first documented response to documented disease progression.	Up to 2 years
Phase II recommended combination doses (RP2CD)	The recommended dosage for drug combination therapy in the second phase of clinical trials (i.e. Phase II clinical trials).	Baseline up to 24 months
Objective Response Rate (ORR)	Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.	Up to 2 years
Progression-free survival (PFS)	Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.	Up to 2 years
Time to Progression	The time from randomization to obtaining the first objective relief.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elimination half-life (t1/2)	The time required for plasma drug concentration to decrease by half.	Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Area under the plasma concentration-time curve (AUC0-last)	The area enclosed by the plasma concentration curve against the timeline.	Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Apparent Plasma Clearance (CL)	Apparent plasma clearance of TQB2928.	Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Apparent volume of distribution(Vz)	The ratio of the amount of TQB2928 in the body to the blood concentration.	Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Steady-state trough concentration (Css-min)	Minimum concentration during dosing.	Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Immunogenicity: anti-drug antibody (ADA)	Incidence of anti-drug antibody (ADA).	From the time of informed consent signed through 90 days after the last dose
Adverse Events (AE) rate	The occurrence and severity of all AEs.	From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 1, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Estimated): September 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: TQB2928-Ib-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No