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 Number: NCT06585059
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Non-small Cell Lung Cancer
Interventions: DRUG: TQB2928 injection + Almonertinib Mesilate Tablets
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

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).

Primary Outcome Measures: 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|Duration of Response (DOR), Defined as the time from first documented response to documented disease progression., 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: 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