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NCT Number: NCT06585059

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Phase II recommended combination doses (RP2CD)

    Time frame: Baseline up to 24 months

    The recommended dosage for drug combination therapy in the second phase of clinical trials (i.e. Phase II clinical trials).

  2. Objective Response Rate (ORR)

    Time frame: Up to 2 years

    Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.

  3. Duration of Response (DOR)

    Time frame: Up to 2 years

    Defined as the time from first documented response to documented disease progression.

  4. Progression-free survival (PFS)

    Time frame: Up to 2 years

    Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.

  5. Time to Progression

    Time frame: Up to 2 years

    The time from randomization to obtaining the first objective relief.

Secondary outcomes

  1. Elimination half-life (t1/2)

    Time frame: 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)

    The time required for plasma drug concentration to decrease by half.

  2. Area under the plasma concentration-time curve (AUC0-last)

    Time frame: 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)

    The area enclosed by the plasma concentration curve against the timeline.

  3. Apparent Plasma Clearance (CL)

    Time frame: 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 of TQB2928.

  4. Apparent volume of distribution(Vz)

    Time frame: 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)

    The ratio of the amount of TQB2928 in the body to the blood concentration.

  5. Steady-state trough concentration (Css-min)

    Time frame: 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)

    Minimum concentration during dosing.

  6. Immunogenicity: anti-drug antibody (ADA)

    Time frame: From the time of informed consent signed through 90 days after the last dose

    Incidence of anti-drug antibody (ADA).

  7. Adverse Events (AE) rate

    Time frame: From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first

    The occurrence and severity of all AEs.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Zhang, Doctor

CONTACT

[email protected]

020-87343458

Wenfeng Fang, Doctor

CONTACT

[email protected]

15322302066

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 5, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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