Limited-stage Small-cell Lung CancerPhase 2NCT07798947
A Phase II Clinical Study of SHR-7787 Injection Combined With SHR-1316 Injection in Patients With LS-SCLC
A Phase 2 study testing SHR-7787 Injection and SHR-1316 in people with Limited-stage Small-cell Lung Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, multicenter, phase II clinical study designed to evaluate the preliminary efficacy, safety, and tolerability of SHR-7787 in combination with Adebrelimab in patients with limited-stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Limited-stage Small-cell Lung Cancer
- What is being tested?
- SHR-7787 Injection and SHR-1316
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2026to Dec 2028
- Phase
- Phase 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
- Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form (ICF) in writing.
- Aged 18 to 75 years (inclusive), of any gender.
- Histologically or cytologically confirmed unresectable limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemotherapy and radiation therapy.
- ECOG performance status score of 0 or 1.
- Estimated survival time of more than 3 months.
- Have adequate bone marrow and organ function.
- Female trial participants of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug, and avoid donating eggs.
Who cannot join
- Combined small cell lung cancer or any transformed small cell lung cancer.
- History of other malignancies within 5 years prior to the first dose of the study drug.
- Severe cardiovascular or cerebrovascular diseases.
- Bleeding symptoms of significant clinical relevance within 3 months prior to the first dose of the study drug.
- Malignant pleural effusion or malignant pericardial effusion.
- Severe infection within 4 weeks prior to the initiation of study treatment.
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- Active tuberculosis infection within 1 year prior to enrollment, identified by medical history or imaging examination.
- History of immunodeficiency.
- Active, known, or suspected autoimmune disease, or a history of autoimmune disease.
- Prior treatment with immune checkpoint inhibitors (ICIs).
- Undergone major organ surgery within 4 weeks prior to the first dose of the study drug.
- Any other factors that, in the judgment of the investigator, may affect the study results or force premature termination of the study.
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
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Jinming Yu, +86-0531-67626073, sdyujinming@126.com
Jinming Yu
About this study
Official title: A Multicenter, Open-label, Phase Ⅱ Clinical Study of SHR-7787 Injection Combined With Adebrelimab in Patients With Limited Stage Small Cell Lung Cancer
This study is an open-label, multicenter, phase II clinical study designed to evaluate the preliminary efficacy, safety, and tolerability of SHR-7787 in combination with Adebrelimab in patients with limited-stage small cell lung cancer.
- Conditions
- Limited-stage Small-cell Lung Cancer
- Being tested
- SHR-7787 Injection, SHR-1316
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-7787 InjectionDrug
SHR-7787 injection.
SHR-1316Drug
SHR-1316 (Adebrelimab) Injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-7787 (Dose 1) + SHR-1316 group | Experimental | Not described Receives: Drug: SHR-7787 Injection; Drug: SHR-1316 |
| SHR-7787 (Dose 2) + SHR-1316 group | Experimental | Not described Receives: Drug: SHR-7787 Injection; Drug: SHR-1316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
The dose expansion part of Phase 1
Measured: Approximately 3 weeks
Incidence and severity of serious adverse events (SAEs)
The dose expansion part of Phase 1
Measured: Approximately 3 weeks
Progression-Free Survival (PFS)
The dose expansion part of Phase 1
Measured: Approximately 16 months
Progression-Free Survival (PFS)
The efficacy expansion part of Phase 2
Measured: Approximately 16 months
Secondary outcomes (12)
Overall Survival (OS)
The dose expansion part of Phase 1
Measured: Approximately 16 months
Objective Response Rate (ORR)
The dose expansion part of Phase 1
Measured: Approximately 16 months
Duration of Response (DoR)
The dose expansion part of Phase 1
Measured: Approximately 16 months
Anti-Drug Antibody (ADA) of SHR-7787
The dose expansion part of Phase 1
Measured: Approximately 16 months
Disease Control Rate (DCR)
The dose expansion part of Phase 1
Measured: Approximately 16 months
Disease Control Rate (DCR)
The efficacy expansion part of Phase 2
Measured: Approximately 16 months
Overall Survival (OS)
The efficacy expansion part of Phase 2
Measured: Approximately 16 months
Objective Response Rate (ORR)
The efficacy expansion part of Phase 2
Measured: Approximately 16 months
Duration of Response (DoR)
The efficacy expansion part of Phase 2
Measured: Approximately 16 months
Anti-Drug Antibody (ADA) of SHR-7787
The efficacy expansion part of Phase 2
Measured: Approximately 16 months
Incidence and severity of adverse events (AEs)
The efficacy expansion part of Phase 2
Measured: Approximately 16 months
Incidence and severity of serious adverse events (SAEs)
The efficacy expansion part of Phase 2
Measured: Approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start7 Oct 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- SHR-7787 combined with SHR-1316.
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT07798947
- Sponsor's protocol ID
- SHR-7787-201-LS-SCLC
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2026
- Last updated
- 19 Oct 2026
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase Ⅱ Clinical Study of SHR-7787 Injection Combined With Adebrelimab in Patients With Limited Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07798947
- Acronym / sponsor ID
- SHR-7787-201-LS-SCLC
- Conditions
- Limited-stage Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Sep 2026 (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 an open-label, multicenter, phase II clinical study designed to evaluate the preliminary efficacy, safety, and tolerability of SHR-7787 in combination with Adebrelimab in patients with limited-stage small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SHR-7787 combined with SHR-1316.
| Arm | Type | Receives |
|---|---|---|
| SHR-7787 (Dose 1) + SHR-1316 group | Experimental | Drug: SHR-7787 Injection, Drug: SHR-1316 |
| SHR-7787 (Dose 2) + SHR-1316 group | Experimental | Drug: SHR-7787 Injection, Drug: SHR-1316 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form (ICF) in writing.
- Aged 18 to 75 years (inclusive), of any gender.
- Histologically or cytologically confirmed unresectable limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemotherapy and radiation therapy.
- ECOG performance status score of 0 or 1.
- Estimated survival time of more than 3 months.
Key exclusion criteria (12 listed)
- Combined small cell lung cancer or any transformed small cell lung cancer.
- History of other malignancies within 5 years prior to the first dose of the study drug.
- Severe cardiovascular or cerebrovascular diseases.
- Bleeding symptoms of significant clinical relevance within 3 months prior to the first dose of the study drug.
- Malignant pleural effusion or malignant pericardial effusion.
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-7787 InjectionSHR-7787 injection. | Drug | SHR-7787 (Dose 1) + SHR-1316 group, SHR-7787 (Dose 2) + SHR-1316 group |
| SHR-1316SHR-1316 (Adebrelimab) Injection. | Drug | SHR-7787 (Dose 1) + SHR-1316 group, SHR-7787 (Dose 2) + SHR-1316 group |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Approximately 3 weeks
The dose expansion part of Phase 1
Incidence and severity of serious adverse events (SAEs)
Time frame: Approximately 3 weeks
The dose expansion part of Phase 1
Progression-Free Survival (PFS)
Time frame: Approximately 16 months
The dose expansion part of Phase 1
Progression-Free Survival (PFS)
Time frame: Approximately 16 months
The efficacy expansion part of Phase 2
12 secondary outcomes
Overall Survival (OS)
Time frame: Approximately 16 months
Objective Response Rate (ORR)
Time frame: Approximately 16 months
Duration of Response (DoR)
Time frame: Approximately 16 months
Anti-Drug Antibody (ADA) of SHR-7787
Time frame: Approximately 16 months
Disease Control Rate (DCR)
Time frame: Approximately 16 months
Disease Control Rate (DCR)
Time frame: Approximately 16 months
Overall Survival (OS)
Time frame: Approximately 16 months
Objective Response Rate (ORR)
Time frame: Approximately 16 months
Duration of Response (DoR)
Time frame: Approximately 16 months
Anti-Drug Antibody (ADA) of SHR-7787
Time frame: Approximately 16 months
Incidence and severity of adverse events (AEs)
Time frame: Approximately 16 months
Incidence and severity of serious adverse events (SAEs)
Time frame: Approximately 16 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 19 Oct 2026.
- 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 2 study testing SHR-7787 Injection and SHR-1316 in people with Limited-stage 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 7 inclusion and 12 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 19 Oct 2026. 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 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 Xiaoxia Lu (+86-0518-82342973, xiaoxia.lu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Approximately 3 weeks). The study lists 4 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 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.