A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer

June 27, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Phase II/III Clinical Study on the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Perioperative Treatment of Resectable Stage II/III Non Small Cell Lung Cancer.

This is a clinical study on the efficacy and safety of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of resectable non-small cell lung cancer. The part I study was planned to enroll 58 subjects, 1:1 randomized into two cohorts. The treatment regimen was as follows: Cohort 1: 3-4 cycles of TQB2450 combined with chemotherapy, surgery should be performed 4-6 weeks after the last administration, and TQB2450 therapy should be continued for 1 year after surgery. Cohort 2: 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsule. Surgery was performed 4-6 weeks after the last dose and continued for 1 year starting 4 weeks after surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer hospital
        • Contact:
        • Contact:
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital of Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 101149
        • Not yet recruiting
        • Beijing Chest Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100027
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
    • Shandong
      • Weifang, Shandong, China, 261044
        • Recruiting
        • Weifang People's Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Not yet recruiting
        • Shanghai Chest Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Recruiting
        • Shanxi Cancer Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300222
        • Recruiting
        • Tianjin Chest Hospital
        • Contact:
          • Daqiang Sun, Doctor
          • Phone Number: +86 13034337758
          • Email: sdqmd@163.com
      • Tianjin, Tianjin, China, 300070
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with stage II-IIIB (T3N2M0 only) Non-Small Cell Lung Carcinoma (NSCLC) and determined to be eligible for curable R0 excision, after pathologic diagnosis of puncture specimens;
  • ≥18 years old (calculated on the date of signing the informed consent); Both men and women; Eastern Cooperative Oncology Group (ECOG) score 0~1; Predicted survival ≥3 months;
  • Have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria within 28 days prior to initiation of treatment;
  • Has not received systemic antitumor therapy, including radiotherapy, chemotherapy and immunotherapy;
  • Agree to provide fresh or 6 month tumor tissue for programmed death ligand -1 (PD-L1) testing.
  • Major organs are functioning well.
  • Women of reproductive age should agree that they must use effective birth control during the study period and for 6 months after the study, and that a negative serum or urine pregnancy test occurred within 7 days prior to study enrollment; Men should agree that effective contraception must be used during the study period and for 6 months after the study period ends.
  • The subjects voluntarily joined the study and signed the informed consent with good compliance.

Exclusion Criteria:

  • Present or complication with other malignancies within 5 years.
  • Subjects are known to have genetic abnormalities with approved targeted drug therapy.
  • Cirrhosis, active hepatitis;
  • Cardio-cerebrovascular abnormalities;
  • Subjects with severe active infection within 4 weeks prior to initiation of study treatment; Or unexplained fever >38.0 ℃ occurred during screening and before first administration;
  • Patients with active tuberculosis within 1 year prior to enrollment;
  • Immunodeficiency disease;
  • History of active autoimmune disease or autoimmune disease;
  • Preparing for or having previously received an organ transplant, or having received a hematopoietic stem cell transplant within 60 days prior to initial medication, or having a significant host transplant response;
  • Patients who required immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and continued use within two weeks prior to randomization
  • Severe infection of grade 4 or higher occurred within 1 year prior to initiation of study therapy;
  • Severe lung disease;
  • History of pituitary or adrenal dysfunction;
  • History of severe mental disorder;
  • History of drug abuse, alcoholism or drug use;
  • Participated in clinical trials of other drugs within 30 days;
  • History of live attenuated vaccine vaccination within 28 days prior to randomization or planned live attenuated vaccine vaccination during the study period;
  • Received Chinese patent drugs with anti-tumor indications specified in the National Medical Product Administration approved drug package inserts within 2 weeks prior to initiation of administration
  • Had major surgery within 4 weeks prior to initiation of medication;
  • Other severe, acute, or chronic medical conditions or laboratory abnormalities that, in the investigator's opinion, may increase the risks associated with study participation or may interfere with the interpretation of the study results, or are otherwise unsuitable for participation in the clinical study;
  • The compliance of patients to participate in this clinical study is estimated to be insufficient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TQB2450 injection + Chemotherapy
TQB2450 injection combined with chemotherapy, 21 days as a treatment cycle.
Drug: TQB2450 injection + Chemotherapy

TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1).

Chemotherapy is a systematic treatment that kill fast growing cells.
Experimental: TQB2450 injection + Anlotinib Hydrochloride Capsule
TQB2450 injection combined with anlotinib hydrochloride capsule, 21 days as a treatment cycle.
Drug: TQB2450 injection + Anlotinib Hydrochloride Capsule

TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1).

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major pathologic response (MPR)
Time Frame: Baseline up to 60 months.
MPR defined as the percentage of subjects with a residual surviving tumor less than or equal to 10% after surgery.
Baseline up to 60 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Baseline up to 60 months.
From randomization to the time of death from any cause.
Baseline up to 60 months.
2/3 year OS rate
Time Frame: Baseline up to 36 months.
The ratio of two-year survival to three-year survival.
Baseline up to 36 months.
Event free survival (EFS) assessed by the investigator.
Time Frame: Baseline up to 60 months.
From the time of randomization to the occurrence of a predetermined event, including death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc.
Baseline up to 60 months.
Disease free survival (DFS) assessed by Blinded Independent Central Review (BICR)
Time Frame: Baseline up to 60 months.
The time from randomization to the onset of tumor recurrence or death from any cause.
Baseline up to 60 months.
Pathological complete response (pCR)
Time Frame: Baseline up to 4 months.
Ratio of patients with no residual cancer cells found in the pathological examination after treatment.
Baseline up to 4 months.
R0 resection rate
Time Frame: Baseline up to 4 months.
The proportion of subjects who could undergo R0 resection, which is one of the surgery-related end points.
Baseline up to 4 months.
Surgical delay rate
Time Frame: Baseline up to 4 months.
The proportion of subjects who could not undergo surgery in time after neoadjuvant therapy.
Baseline up to 4 months.
Pathological downgrading rate
Time Frame: Baseline up to 4 months.
The proportion of patients with reduced lung cancer stage determined by pathological results after surgery.
Baseline up to 4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TQB2450-II/III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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