Non-Small Cell Lung CancerPhase 1/2NCT06589778
A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 1/2 study testing SHR-A2102, Adebelimab (SHR-1316) and SHR-8068 in people with Non-Small Cell Lung Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- SHR-A2102, Adebelimab (SHR-1316) and SHR-8068
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2024to 30 Apr 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- Age 18~70 years old.
- Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer.
- At least one measurable lesion per RECIST v1.1 criteria.
- ECOG PS score: 0-1.
Who cannot join
- Active or symptomatic brain metastases.
- Previous diagnosis of any other malignancy.
- Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.
- Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
- Uncontrolled tumor-related pain.
- Subjects with severe cardiovascular and cerebrovascular diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Hua Zhong
About this study
Official title: Safety, Tolerability, and Efficacy of SHR-A2102 in Combination With Adebrelimab, With SHR-8068, in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase IB/II Open-Label, Multicenter Clinical Study
This study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- SHR-A2102, Adebelimab (SHR-1316), SHR-8068
- 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-A2102Drug
SHR-A2102: injection, 80mg/ bottle, intravenous drip
Adebelimab (SHR-1316)Drug
Adebelimab (SHR-1316): injection, 600mg(12mL)/ bottle, intravenous drip
SHR-8068Drug
SHR-8068: injection, 50mg（10mL）/ bottle, intravenous drip
| Study group | Role | What they receive |
|---|---|---|
| SHR-A2102 in Combination with Adebrelimab and SHR-8068 | Experimental | Not described Receives: Drug: SHR-A2102; Drug: Adebelimab (SHR-1316); Drug: SHR-8068 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Recommended Phase II dose (RP2D)
Measured: From first dose of study treatment until the end of Cycle 1（up to 21 days）
Objective Response Rate (ORR)
The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.
Measured: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)
Incidence and severity of AEs
Measured: The observation period ended at the end of the 21-day period after the first dose of SHR-A2102 or Adebrelimab or SHR-8068 (up to 21 days)
Secondary outcomes (4)
Disease Control Rate (DCR)
The percentage of participants who have a best objective response of confirmed CR or PR or who have SD after start of treatment.
Measured: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)
Duration of Response (DoR)
The time from the date of first response until date of disease progression or death in the absence of disease progression.
Measured: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)]
Progression free Survival (PFS)
Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death.
Measured: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)
Overall Survival (OS)
The time until death due to any cause.
Measured: From time of first dose of objective disease progression until the date of death (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Sep 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589778
- Sponsor's protocol ID
- SHR-A2102-206
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 12 Nov 2024
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Efficacy of SHR-A2102 in Combination With Adebrelimab, With SHR-8068, in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase IB/II Open-Label, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06589778
- Acronym / sponsor ID
- SHR-A2102-206
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Sep 2024 (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 multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A2102 in Combination with Adebrelimab and SHR-8068 | Experimental | Drug: SHR-A2102, Drug: Adebelimab (SHR-1316), Drug: SHR-8068 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- Age 18~70 years old.
- Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer.
- At least one measurable lesion per RECIST v1.1 criteria.
- ECOG PS score: 0-1.
Key exclusion criteria (6 listed)
- Active or symptomatic brain metastases.
- Previous diagnosis of any other malignancy.
- Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.
- Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
- Uncontrolled tumor-related pain.
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-A2102SHR-A2102: injection, 80mg/ bottle, intravenous drip | Drug | SHR-A2102 in Combination with Adebrelimab and SHR-8068 |
| Adebelimab (SHR-1316)Adebelimab (SHR-1316): injection, 600mg(12mL)/ bottle, intravenous drip | Drug | SHR-A2102 in Combination with Adebrelimab and SHR-8068 |
| SHR-8068SHR-8068: injection, 50mg（10mL）/ bottle, intravenous drip | Drug | SHR-A2102 in Combination with Adebrelimab and SHR-8068 |
Primary outcome
Determination of Recommended Phase II dose (RP2D)
Time frame: From first dose of study treatment until the end of Cycle 1（up to 21 days）
Objective Response Rate (ORR)
Time frame: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)
The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.
Incidence and severity of AEs
Time frame: The observation period ended at the end of the 21-day period after the first dose of SHR-A2102 or Adebrelimab or SHR-8068 (up to 21 days)
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)
Duration of Response (DoR)
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)]
Progression free Survival (PFS)
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)
Overall Survival (OS)
Time frame: From time of first dose of objective disease progression until the date of death (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-A2102, Adebelimab (SHR-1316) and SHR-8068 in people with Non-Small Cell Lung Cancer, run by Shanghai Hengrui Pharmaceutical 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 5 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: status not confirmed, as of the sponsor's last update on 12 Nov 2024. 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 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?
Determination of Recommended Phase II dose (RP2D) (time frame: From first dose of study treatment until the end of Cycle 1（up to 21 days）). The study lists 3 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 12 Nov 2024.