Non-small Cell Lung Cancer (NSCLC)Phase 1/2NCT06754930
A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC
A Phase 1/2 study testing SHR-1826, SHR-1316 and SHR-9839 in people with Non-small Cell Lung Cancer (NSCLC), run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- SHR-1826, SHR-1316 and SHR-9839
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to Dec 2027
- Phase
- Phase 1/2
- 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 older, no gender limitation.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
- With a life expectancy ≥ 3 months.
- Pathologically diagnosed NSCLC.
- Be able to provide fresh or archived tumour tissue.
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- At least one measurable lesion according to RECIST v1.1.
- Adequate organ function.
- Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
Who cannot join
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
- Previous or co-existing malignancies.
- Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
- Uncontrollable tumor-related pain.
- Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
- Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
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- Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy.
- With poorly controlled or severe cardiovascular disease.
- Active hepatitis B and hepatitis C.
- Patients with a history of immunodeficiency.
- Severe infection 30 days before the first dose.
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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu, +86-13601813062, shun_lu@hotmail.com
Shun Lu
About this study
Official title: A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer
This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- SHR-1826, SHR-1316, SHR-9839, SHR-8068, Ametinib mesylate
- 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-1826Drug
SHR-1826 for injection.
SHR-1316Drug
SHR-1316 for injection.
SHR-9839Drug
SHR-9839 for injection.
SHR-8068Drug
SHR-8068 for injection.
Ametinib mesylateDrug
Ametinib mesylate.
BP-102Drug
BP-102 for injection.
CarboplatinDrug
Carboplatin for injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: SHR-1826; Drug: SHR-1316; Drug: SHR-9839; Drug: SHR-8068; Drug: Ametinib mesylate; Drug: BP-102; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase II dose (RP2D)
Measured: Screening up to study completion, an average of 1 year.
Adverse events (AEs)
Measured: Screening up to study completion, an average of 1 year.
Objective response rate (ORR)
Measured: Screening up to study completion, an average of 1 year.
Secondary outcomes (7)
Disease control rate (DCR)
Measured: Screening up to study completion, an average of 1 year.
Duration of response (DoR)
Measured: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS)
Measured: Screening up to study completion, an average of 1 year.
Overall survival (OS)
Measured: Screening up to study completion, an average of 1 year.
Drug resistant antibody (ADA) to SHR-1826
Measured: Screening up to study completion, an average of 1 year.
Blood concentration of SHR-1826
Measured: Screening up to study completion, an average of 1 year.
Blood concentration of free toxin
Measured: Screening up to study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start18 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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 Cancer (NSCLC)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 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
- NCT06754930
- Sponsor's protocol ID
- SHR-1826-201-LC
- Status last verified
- Apr 2025
- First submitted
- 24 Dec 2024
- Last updated
- 17 Apr 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 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06754930
- Acronym / sponsor ID
- SHR-1826-201-LC
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Jan 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 is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: SHR-1826, Drug: SHR-1316, Drug: SHR-9839, Drug: SHR-8068, Drug: Ametinib mesylate, Drug: BP-102, Drug: Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary participation and written informed consent.
- 18-75 years older, no gender limitation.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
- With a life expectancy ≥ 3 months.
- Pathologically diagnosed NSCLC.
Key exclusion criteria (11 listed)
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
- Previous or co-existing malignancies.
- Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
- Uncontrollable tumor-related pain.
- Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
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-1826SHR-1826 for injection. | Drug | Experimental group |
| SHR-1316SHR-1316 for injection. | Drug | Experimental group |
| SHR-9839SHR-9839 for injection. | Drug | Experimental group |
| SHR-8068SHR-8068 for injection. | Drug | Experimental group |
| Ametinib mesylateAmetinib mesylate. | Drug | Experimental group |
| BP-102BP-102 for injection. | Drug | Experimental group |
| CarboplatinCarboplatin for injection. | Drug | Experimental group |
Primary outcome
Recommended phase II dose (RP2D)
Time frame: Screening up to study completion, an average of 1 year.
Adverse events (AEs)
Time frame: Screening up to study completion, an average of 1 year.
Objective response rate (ORR)
Time frame: Screening up to study completion, an average of 1 year.
7 secondary outcomes
Disease control rate (DCR)
Time frame: Screening up to study completion, an average of 1 year.
Duration of response (DoR)
Time frame: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS)
Time frame: Screening up to study completion, an average of 1 year.
Overall survival (OS)
Time frame: Screening up to study completion, an average of 1 year.
Drug resistant antibody (ADA) to SHR-1826
Time frame: Screening up to study completion, an average of 1 year.
Blood concentration of SHR-1826
Time frame: Screening up to study completion, an average of 1 year.
Blood concentration of free toxin
Time frame: Screening up to study completion, an average of 1 year.
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 17 Apr 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 1/2 study testing SHR-1826, SHR-1316 and SHR-9839 in people with Non-small Cell Lung Cancer (NSCLC), 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 9 inclusion and 11 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 17 Apr 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 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?
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 Yijun Jia (+86-18801784695, yijun.jia@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended phase II dose (RP2D) (time frame: Screening up to study completion, an average of 1 year.). 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 17 Apr 2025.