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Advanced Non-small Cell Lung CancerPhase 1/2NCT05416775

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

A Phase 1/2 study testing SHR-8068；Adebrelimab, SHR-8068；adebrelimab and platinum-based chemotherapy and Adebrelimab；platinum-based chemotherapy in people with Advanced Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 18 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Non-small Cell Lung Cancer
What is being tested?
SHR-8068；Adebrelimab, SHR-8068；adebrelimab and platinum-based chemotherapy and Adebrelimab；platinum-based chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
18 sitesChina
Study dates
15 Aug 2022to 30 Jun 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18~75 years old, both male and female
  • Stage 1: pathologically diagnosed, incurable NSCLC subjects who have failed standard treatment
  • 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
  • At least one measurable lesion based on RECIST v1.1 criteria
  • ECOG PS score: 0-1 points
  • Expected survival period ≥ 3 months
  • Good levels of organ function
  • Patients voluntarily joined the study and signed informed consent

Who cannot join

  • Patients with EGFR activating mutation, positive ALK fusion gene or known ROS1 fusion gene
  • Untreated brain metastases; or associated with meningeal metastases, spinal cord compression, etc.
  • Uncontrolled pleural, pericardial, or ascites with clinical symptoms
  • Severe bone damage caused by tumor bone metastasis
  • Suffering from other malignant tumors in the past 3 years or at the same time
  • Presence of any active or known autoimmune disease
Show all 17Show fewer
  • Systemic treatment with corticosteroids or other immunosuppressants within 2 weeks before the first dose
  • Have clinical symptoms or diseases of the heart that are not well controlled
  • Serious infection occurred within 1 month before the first dose
  • 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
  • With active pulmonary tuberculosis
  • Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known active viral hepatitis
  • Known history of inflammatory bowel disease
  • Inoculated with live attenuated vaccine within 28 days before the first dose
  • Known allergic reaction to other monoclonal antibodies
  • 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
  • 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.

Trial locations and contacts

18 sites in 1 country.

Xin Xu contact

0518-82342973

xin.xu@hengrui.com

Weixia Li contact

0518-82342973

weixia.li@hengrui.com

18 sites in 1 country

China18 sites, 18 recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130103

    Ying Cheng

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Yongzhong Luo

    Not yet recruiting

  • West China Hospital Of Sichuan University

    Chengdu, Chengdu, 610000

    Yan Zhang

    Not yet recruiting

  • Cancer Hospital Affiliated to Chongqing University

    Chongqing, Chongqing Municipality, 400030

    Yongsheng Li

    Not yet recruiting

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550002

    Yu Zhang

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Yan Wang

    Not yet recruiting

  • Anhui Chest Hospital

    Hefei, Anhui, 230000

    Haohui Fang

    Not yet recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

    Xinghua Han

    Not yet recruiting

  • Affiliated Tumor Hospital of Shandong First Medical University

    Jinan, Shandong, 250000

    Baosheng Li

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunan, 650106

    Runxiang Yang

    Not yet recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

    Jifeng Feng

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530022

    Zhiyi He

    Not yet recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, 214000

    Yong Mao

    Not yet recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441000

    Tienan Yi

    Not yet recruiting

  • North Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

    Lingfeng Min

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Yanqiu Zhao

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Gunjun Zhang

    Not yet recruiting

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563003

    Liang Zhou

    Not yet recruiting

Other trials in China

About this study

Official title: 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

Being tested
SHR-8068；Adebrelimab, SHR-8068；adebrelimab and platinum-based chemotherapy, Adebrelimab；platinum-based chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-8068；AdebrelimabDrug

    SHR-8068: Sterile Injection, 50mg/10mL, Intravenous Infusion Adebrelimab: injection, 600mg/12mL, intravenous infusion

  • SHR-8068；adebrelimab and platinum-based chemotherapyDrug

    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

  • Adebrelimab；platinum-based chemotherapyDrug

    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

Study groups in NCT05416775
Study groupRoleWhat they receive
SHR-8068 in combination with adebrelimabExperimentalNot described
Receives: Drug: SHR-8068；Adebrelimab
SHR-8068 in combination with adebrelimab and platinum-based chemotherapyExperimentalNot described
Receives: Drug: SHR-8068；adebrelimab and platinum-based chemotherapy
Adebrelimab in combination with platinum-based chemotherapyExperimentalNot described
Receives: Drug: Adebrelimab；platinum-based chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity

    Measured: The observation period is 21 days after the first dose

  2. Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points;

    Measured: up to 2 years

Secondary outcomes (2)

  1. Disease Control Rate, determined using RECIST v1.1 criteria

    Measured: up to 2 years

  2. Progression-Free-Survival assessed by investigator

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2022
  2. Study start15 Aug 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a multicenter, open-label, dose-finding and efficacy-expansion phase Ib/II study. The first stage is for dose finding, using modified 3+3 design; the second stage is for dose confirmation and efficacy expansion through randomization.
Masking
None (open label)
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05416775
Sponsor's protocol ID
SHR-8068-II-201-NSCLC
Status last verified
May 2022
First submitted
27 May 2022
Last updated
19 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-8068；Adebrelimab, SHR-8068；adebrelimab and platinum-based chemotherapy and Adebrelimab；platinum-based chemotherapy in people with Advanced Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xin Xu (0518-82342973, xin.xu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (time frame: The observation period is 21 days after the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05416775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.

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