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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2928 injection + Almonertinib Mesilate Tablets | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2928 injection + Almonertinib Mesilate Tablets | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, Doctor | Contact | 020-87343458 | Zhangli@syscc.cn | |
| Wenfeng Fang, Doctor | Contact | 15322302066 | fangwf@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| 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 |