Advanced or Metastatic Non-small Cell Lung CancerPhase 3NCT07170995
Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 3 study testing SHR-8068，adebelizumab and platinum-based chemotherapy and tislelizumab, and platinum-based chemotherapy in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced or Metastatic Non-small Cell Lung Cancer
- What is being tested?
- SHR-8068，adebelizumab and platinum-based chemotherapy and tislelizumab, and platinum-based chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2025to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Voluntary participation and written informed consent.
- 18-75 years old, no gender limitation.
- Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.
- Confirmed tumor PD-L1 status prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1
- With a life expectancy ≥ 3 months.
- At least one measurable lesion according to RECIST v1.1.
Who cannot join
- Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
- Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Previous or co-existing malignancies；
- Have Active or prior documented autoimmune or inflammatory disorders;
- Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
- Have an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Jinming Yu
About this study
Official title: A Randomized, Open-label, Controlled, Multicenter Phase III Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy Versus Tislelizumab Combined With Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer
This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.
- Being tested
- SHR-8068，adebelizumab and platinum-based chemotherapy, tislelizumab, and platinum-based chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-8068，adebelizumab and platinum-based chemotherapyDrug
SHR-8068，adebelizumab and platinum-based chemotherapy
tislelizumab, and platinum-based chemotherapyDrug
tislelizumab, and platinum-based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| SHR-8068，adebelizumab and platinum-based chemotherapy | Experimental | Not described Receives: Drug: SHR-8068，adebelizumab and platinum-based chemotherapy |
| tislelizumab, and platinum-based chemotherapy | Active comparator | Not described Receives: Drug: tislelizumab, and platinum-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR]
PFS (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) by BICR was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression)
Measured: Approximately 32 months.
OS
OS was defined as the time from the date of randomization until death due to any cause.
Measured: Approximately 64 months.
Secondary outcomes (5)
PFS by the investigator
PFS (per RECIST 1.1) by the investigator was defined as time from date of randomization until date of objective disease or death (by any cause in the absence of progression)
Measured: Approximately 32 months.
Objective Response Rate (ORR)
ORR (per RECIST 1.1) by BICR or the investigator was defined as the percentage of patients with at least one visit response of complete response (CR) or partial response (PR).
Measured: Approximately 32 months.
Duration of Response (DoR)
DoR (per RECIST 1.1) by BICR or the investigator was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.
Measured: Approximately 32 month
Incidence and Severity of Adverse Events (AEs)
Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 60 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent.
Measured: Approximately 64 months.
Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ C30-Lung Cancer Module 13 (QLQ-LC13)
The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms and treatment-related symptoms from conventional chemotherapy and radiotherapy. Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
Measured: Approximately 64 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start22 Oct 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170995
- Sponsor's protocol ID
- SHR-8068-302
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Controlled, Multicenter Phase III Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy Versus Tislelizumab Combined With Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07170995
- Acronym / sponsor ID
- SHR-8068-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-8068，adebelizumab and platinum-based chemotherapy | Experimental | Drug: SHR-8068，adebelizumab and platinum-based chemotherapy |
| tislelizumab, and platinum-based chemotherapy | Active comparator | Drug: tislelizumab, and platinum-based chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary participation and written informed consent.
- 18-75 years old, no gender limitation.
- Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.
- Confirmed tumor PD-L1 status prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1
Key exclusion criteria (6 listed)
- Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
- Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Previous or co-existing malignancies；
- Have Active or prior documented autoimmune or inflammatory disorders;
- Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-8068，adebelizumab and platinum-based chemotherapySHR-8068，adebelizumab and platinum-based chemotherapy | Drug | SHR-8068，adebelizumab and platinum-based chemotherapy |
| tislelizumab, and platinum-based chemotherapytislelizumab, and platinum-based chemotherapy | Drug | tislelizumab, and platinum-based chemotherapy |
Primary outcome
Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR]
Time frame: Approximately 32 months.
PFS (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) by BICR was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression)
OS
Time frame: Approximately 64 months.
OS was defined as the time from the date of randomization until death due to any cause.
5 secondary outcomes
PFS by the investigator
Time frame: Approximately 32 months.
Objective Response Rate (ORR)
Time frame: Approximately 32 months.
Duration of Response (DoR)
Time frame: Approximately 32 month
Incidence and Severity of Adverse Events (AEs)
Time frame: Approximately 64 months.
Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ C30-Lung Cancer Module 13 (QLQ-LC13)
Time frame: Approximately 64 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-8068，adebelizumab and platinum-based chemotherapy and tislelizumab, and platinum-based chemotherapy in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weixia Li (+86 021-61053363, weixia.li@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR] (time frame: Approximately 32 months.). 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?
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 18 Nov 2025.