Phase Ib/II Study of SHR-8068 Injection in the Treatment of Advanced Non-small Cell Lung Cancer

August 17, 2022 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer

To evaluate the tolerability and safety of SHR-8068 in combination with adebrelimab in subjects with advanced NSCLC To evaluate the efficacy of SHR-8068 in combination with adebrelimab and platinum-based chemotherapy in subjects with advanced NSCLC

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 (Anticipated)

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.
168

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
  • Phase 1

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 Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • Anhui Chest Hospital
        • Principal Investigator:
          • Haohui Fang
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Xinghua Han
    • Chengdu
      • Chengdu, Chengdu, China, 610000
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Principal Investigator:
          • Yan Zhang
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Not yet recruiting
        • Cancer Hospital Affiliated to Chongqing University
        • Principal Investigator:
          • Yongsheng Li
    • Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi Zhuang Autonomous Region, China, 530022
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Principal Investigator:
          • Zhiyi He
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Not yet recruiting
        • Guizhou Provincial People's Hospital
        • Principal Investigator:
          • Yu Zhang
      • Zunyi, Guizhou, China, 563003
        • Not yet recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Principal Investigator:
          • Liang Zhou
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Gunjun Zhang
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
    • Hubei
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Xiangyang Central Hospital
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Yongzhong Luo
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Cancer Hospital
      • Wuxi, Jiangsu, China, 214000
        • Not yet recruiting
        • Affiliated Hospital of Jiangnan University
        • Principal Investigator:
          • Yong Mao
      • Yangzhou, Jiangsu, China, 225001
        • Not yet recruiting
        • North Jiangsu People's Hospital
        • Principal Investigator:
          • Lingfeng Min
    • Jilin
      • Changchun, Jilin, China, 130103
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Principal Investigator:
          • Ying Cheng
    • Shandong
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Affiliated Tumor Hospital of Shandong First Medical University
        • Principal Investigator:
          • Baosheng Li
    • Yunan
      • Kunming, Yunan, China, 650106
        • Not yet recruiting
        • Yunnan Cancer Hospital

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18~75 years old, both male and female
  2. Stage 1: pathologically diagnosed, incurable NSCLC subjects who have failed standard treatment
  3. Stage 2: have a histologically or cytologically confirmed diagnosis of relapsed or metastatic NSCLC; have not received prior systemic treatment for their recurrent or metastatic NSCLC; PD-L1 TPS <50% as confirmed by central laboratory
  4. At least one measurable lesion based on RECIST v1.1 criteria
  5. ECOG PS score: 0-1 points
  6. Expected survival period ≥ 3 months
  7. Good levels of organ function
  8. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

  1. Patients with EGFR activating mutation, positive ALK fusion gene or known ROS1 fusion gene
  2. Untreated brain metastases; or associated with meningeal metastases, spinal cord compression, etc.
  3. Uncontrolled pleural, pericardial, or ascites with clinical symptoms
  4. Severe bone damage caused by tumor bone metastasis
  5. Suffering from other malignant tumors in the past 3 years or at the same time
  6. Presence of any active or known autoimmune disease
  7. Systemic treatment with corticosteroids or other immunosuppressants within 2 weeks before the first dose
  8. Have clinical symptoms or diseases of the heart that are not well controlled
  9. Serious infection occurred within 1 month before the first dose
  10. Past or current active interstitial lung disease requiring treatment, non-infectious pneumonia requiring glucocorticoid system treatment; current active pneumonia or pulmonary function test confirmed severe impairment of pulmonary function
  11. With active pulmonary tuberculosis
  12. Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known active viral hepatitis
  13. Known history of inflammatory bowel disease
  14. Inoculated with live attenuated vaccine within 28 days before the first dose
  15. Known allergic reaction to other monoclonal antibodies
  16. Received >30 Gy of pulmonary radiotherapy within 6 months before the first dose; received major surgical treatment, systemic chemotherapy, immunotherapy or other clinical trial drugs within 4 weeks before the first dose; within 2 weeks before the first dose Received palliative radiotherapy; oral molecularly targeted drugs, discontinued to less than 5 half-lives before first dose; failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE ≤1 degree
  17. According to the judgment of the researcher, there are other factors that may affect the results of the study or cause the study to be terminated halfway.

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: SHR-8068 in combination with adebrelimab
Drug: SHR-8068；Adebrelimab
SHR-8068: Sterile Injection, 50mg/10mL, Intravenous Infusion Adebrelimab: injection, 600mg/12mL, intravenous infusion
Experimental: SHR-8068 in combination with adebrelimab and platinum-based chemotherapy
Drug: SHR-8068；adebrelimab and platinum-based chemotherapy
SHR-8068: Intravenous Infusion Adebrelimab: injection, intravenous infusion Pemetrexed disodium for injection: , intravenous drip Paclitaxel for injection (albumin-bound): intravenous drip Paclitaxel injection: intravenous drip Carboplatin injection: intravenous drip Cisplatin injection: intravenous drip
Experimental: Adebrelimab in combination with platinum-based chemotherapy
Drug: Adebrelimab；platinum-based chemotherapy
Adebrelimab: intravenous infusion Pemetrexed disodium for injection: intravenous drip Paclitaxel for injection (albumin-bound): intravenous drip Paclitaxel injection: intravenous drip Carboplatin injection: intravenous drip Cisplatin injection: intravenous drip

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
Time Frame
Dose limiting toxicity
Time Frame: The observation period is 21 days after the first dose
The observation period is 21 days after the first dose
Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points;
Time Frame: up to 2 years
up to 2 years

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
Time Frame
Disease Control Rate, determined using RECIST v1.1 criteria
Time Frame: up to 2 years
up to 2 years
Progression-Free-Survival assessed by investigator
Time Frame: up to 2 years
up to 2 years

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.
Suzhou Suncadia Biopharmaceuticals 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.
August 15, 2022

Primary Completion (Anticipated)

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 30, 2026

Study Completion (Anticipated)

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.
June 30, 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).
May 27, 2022

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 9, 2022

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 13, 2022

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.
August 19, 2022

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.
August 17, 2022

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.
May 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.
  • SHR-8068-II-201-NSCLC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings