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Status unknownNCT05859373Updated May 16, 2023

To Evaluate the Efficacy and Safety of TQB3728 Tablets in Sequential Maintenance of TQB2450 Injection Therapy in Patients After Sequential or Concurrent Chemoradiation for Locally Advanced Non-small Cell Lung Cancer.

A Phase 1/2 interventional study of TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation and TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation in Non-small Cell Lung Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

It's a Phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3728 tablets in sequential maintenance TQB2450 injection therapy in patients after sequential or concurrent chemoradiation for locally advanced non-small cell lung cancer.

Incidence and severity of adverse events (AEs), the type of dose-limiting toxicity(ies) (DLT[s]) and Recommended phaseII dose(RP2D) were the Phase Ib primary endpoint. Overall response rate (ORR) was the Phase II primary endpoint.

02

Conditions studied

  • Non-small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 78 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Between the ages of 18-75 years (calculated based on the date of signing Informed consent form (ICF) ); male or female;
  • Non resectable stage III non-small cell lung cancer (NSCLC) patients confirmed by histopathological or cytological examination；
  • At least one measurable lesion (based on RECIST 1.1)；
  • Has not received any systematic treatment or targeted radiotherapy for locally advanced non-small cell lung cancer;
  • Eastern cooperative oncology group (ECOG) score 0-1;
  • Estimated survival time ≥ 3 months;

  • The main organs function are normally, meeting following criteria:

    1. routine blood tests: hemoglobin (HGB) ≥80g/L (no blood transfusion and blood products within 14 days); absolute neutrophil count (ANC) ≥1.5×109/L; platelets (PLT)≥90×10\^9/L.
    2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);Serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance (CCR) ≥ 60 ml/min.
    3. Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy);
    4. Cardiac ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
  • Female participants should have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Participants should agree that contraception must be used during the study period and for 6 months after the end of the study.

Exclusion criteria

Exclusion Criteria:

  • Comorbidity and medical history:

    1. Have had or currently have other malignant tumors within 2 years. The following two conditions can be enrolled: other malignancies treated with a single surgery; cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ) and T1 (tumor-invasive basement membrane)];
    2. Pathological types of mixed small cell and non-small cell lung cancer components；
    3. Patients with known EGFR/ALK mutations
    4. There was Therapeutic toxicity (≥ CTC AE grade 2 infection)
    5. Have a history of idiopathic pulmonary fibrosis, organized pneumonia, drug-induced pneumonia, or idiopathic pneumonia
    6. Subjects who have received major surgical treatment or obvious traumatic injury within 4 weeks prior to initial administration

  • Tumor related symptoms and treatment

    1. Received Antitumor traditional Chinese medicine treatment within 2 weeks before the start of research treatment；
    2. Previously received other PD-1/PD-L1/CTLA-4 antibody treatments or immunotherapy;
    3. Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage;

  • Research treatment related:

    1. Subjects who have received the vaccine within 4 weeks prior to the first dose, or is planning to be vaccinated during the study period
    2. Individuals with a previous history of severe allergies to macromolecular drugs or severe hypersensitivity reactions after administration of other monoclonal antibodies
    3. Existence of any active autoimmune disease or history of autoimmune disease
  • Subjects who have participated in clinical trials of other anti-tumor drugs within 4 weeks before the first dose
  • According to the judgment of the investigator, subjects with concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects with other reasons which are not suitable for inclusion.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    TQB3728 tablets+chemoradiation, sequential maintenance with TQB2450 injection

    TQB3728 tablets combined with sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4\~6 cycles, sequential maintenance therapy of TQB2450 injection.

    Combination Product: TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation

  • Experimental
    TQB3728 tablets+chemoradiation, sequential maintenance with TQB3728 tablets and TQB2450 injection

    TQB3728 tablets combined with sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4\~6 cycles, sequential maintenance with TQB3728 tablets and TQB2450 injection for 4 cycles. Then sequential maintenance with TQB2450 injection monotherapy；

    Combination Product: TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation

  • Active comparator
    Sequential or concurrent chemoradiation, sequential maintenance with TQB2450 injection.

    Sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4\~6 cycles, sequential maintenance with TQB2450 injection；

    Combination Product: TQB2450 injection, sequential or concurrent chemoradiation

Interventions

  • Combination productTQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation

    TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).

  • Combination productTQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation

    TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).

  • Combination productTQB2450 injection, sequential or concurrent chemoradiation

    TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events (AEs)

    All adverse medical events that occur after the subject receives the investigational drug evaluated according to the National Cancer Institute standard for common toxic reactions (NCI-CTC) V5.0.

    Time frame: Baseline to 30 days after last administration.

  2. Severity of adverse events (AEs)

    All adverse medical events that occur after the subject receives the investigational drug evaluated according to the National Cancer Institute standard for common toxic reactions (NCI-CTC) V5.0.

    Time frame: Baseline to 30 days after last administration.

  3. Dose-limiting toxicity (DLT)

    Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug: grade III or above of non-hematological toxicity, grade IV hematological toxicity, neutropenia associated with fever.

    Time frame: Up to 28 days.

  4. Recommended phase II dose (RP2D)

    The RP2D defined as the lower dose level to maximum tolerated dose based on the safety profile.

    Time frame: Baseline to 30 days after last administration.

  5. Overall response rate (ORR)

    According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the proportion of subjects whose tumors are evaluated as complete response (CR) and partial response (PR) by subcenter imaging evaluation. It is recorded from the first dose of the drug to disease progression or initiation of a new anticancer treatment.

    Time frame: Baseline to the disease progression, up to two years.

Secondary outcomes

  1. Time to reach maximum plasma concentration (Tmax)

    To characterize the pharmacokinetics of TQB3728 by assessment of time to reach maximum plasma concentration.

    Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.

  2. Peak concentration (Cmax)

    Cmax is the maximum plasma concentration of TQB3728 or metabolite(s).

    Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.

  3. Terminal half-life (t1/2)

    Pharmacokinetics parameters to evaluate the half life of TQB3728.

    Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.

  4. Area under the plasma concentration-time curve from time zero to time t.

    To characterize the pharmacokinetics of TQB3728 by assessment of area under the plasma concentration time curve from zero to specific time or infinity.

    Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.

  5. Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)

    Cmax,ss is the steady state maximum concentration of TQB3728.

    Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.

  6. Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss)

    Cmin,ss is the minimum plasma concentration of TQB3728.

    Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.

  7. Disease control rate (DCR)

    Percentage of subjects achieving CR and PR and stable disease (SD).

    Time frame: Baseline to up to two years.

  8. Duration of Response (DOR)

    The period from the subjects first achieving CR or PR to disease progression.

    Time frame: Baseline to up to two years.

  9. Progression-free survival (PFS) at 12 months.

    PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.

    Time frame: Up to 12 months.

  10. Progression-free survival at 18 months.

    PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.

    Time frame: Up to 18 months.

  11. Progression-free survival.

    PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.

    Time frame: Baseline to the disease progression, up to two years.

  12. Overall survival (OS) at 12 months.

    OS is defined as the time from the first administration to all-cause death.

    Time frame: Up to 12 months.

  13. Overall survival (OS) at 18 months.

    OS is defined as the time from the first administration to all-cause death.

    Time frame: Up to 18 months.

  14. Overall survival (OS)

    OS is defined as the time from the first administration to all-cause death.

    Time frame: Baseline to the disease progression, up to two years.

07

Study locations

1 site
  • Cancer Hospital Affiliated to Shandong First Medical University
    Jinan, Shandong 250117, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05859373
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
May 16, 2023
Start date
Jun 2023 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
May 16, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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