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).
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；
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;
Single group
TQB2928 injection + Almonertinib Mesilate Tablets
DrugTQB2928 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.
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).
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.
Duration of Response (DOR)
Defined as the time from first documented response to documented disease progression.
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.
Elimination half-life (t1/2)
The time required for plasma drug concentration to decrease by half.
Area under the plasma concentration-time curve (AUC0-last)
The area enclosed by the plasma concentration curve against the timeline.
Apparent Plasma Clearance (CL)
Apparent plasma clearance of TQB2928.
Apparent volume of distribution(Vz)
The ratio of the amount of TQB2928 in the body to the blood concentration.
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