Widespread Small Cell Lung CancerPhase 1NCT07009457
A Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer
A Phase 1 study testing SHR-1316 (sc) Injection, SHR-1316 Injection and Carboplatin Injection in people with Widespread Small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is a multicenter, open label phase I clinical trial aimed at evaluating the pharmacokinetics, tolerability, safety and immunogenicity of SHR-1316 (sc) subcutaneous administration combined with carboplatin and etoposide as first-line treatment for extensive stage small cell lung cancer, and to observe the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Widespread Small Cell Lung Cancer
- What is being tested?
- SHR-1316 (sc) Injection, SHR-1316 Injection and Carboplatin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2025to Sep 2028
- Phase
- Phase 1
- 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
- Patients with extensive stage small cell lung cancer confirmed by histology or cytology; Has not received first-line systemic therapy or immune checkpoint inhibitor treatment for ES-SCLC in the past.
- ECOG physical fitness score 0-1 points.
- According to RECIST v1.1, there must be at least one measurable tumor lesion.
- Expected survival time ≥ 12 weeks.
- Having sufficient bone marrow and organ function.
- Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form.
Who cannot join
- Patients with central nervous system or meningeal metastases.
- Spinal cord compression that cannot be cured by surgery and/or radiotherapy cannot be included in the study.
- Patients diagnosed by researchers with uncontrollable tumor related pain.
- Symptomatic third space effusion requires repeated drainage, such as pericardial effusion, pleural effusion, and abdominal effusion that cannot be controlled by pumping or other treatments.
- Having undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first use of the investigational drug, or requiring elective surgery during the trial period.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or clinically significant active pneumonia at screening; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area may participate in this study).
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- Severe infections, including but not limited to bacteremia requiring hospitalization and severe pneumonia, were present within 4 weeks prior to the first medication; Within 2 weeks prior to the first medication, there is an active infection with CTCAE ≥ 2 that requires treatment with systemic antibiotics.
- Individuals with active pulmonary tuberculosis infection detected through medical history or CT examination within the year prior to enrollment, or those with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment.
- History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplant recipients.
- Known to have alcohol or drug dependence; Individuals with mental disorders or poor compliance; Pregnant or lactating women; Or the researcher believes that there is a history of other serious systemic diseases or other reasons that make it unsuitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200
About this study
Official title: An Open Label, Multicenter Phase I Clinical Study on the Pharmacokinetics, Safety, Tolerability, and Efficacy of SHR-1316 (SC) Combined With Carboplatin and Etoposide in First-line Treatment of Extensive Stage Small Cell Lung Cancer
This study is a multicenter, open label phase I clinical trial aimed at evaluating the pharmacokinetics, tolerability, safety and immunogenicity of SHR-1316 (sc) subcutaneous administration combined with carboplatin and etoposide as first-line treatment for extensive stage small cell lung cancer, and to observe the initial anti-tumor efficacy.
- Conditions
- Widespread Small Cell Lung Cancer
- Being tested
- SHR-1316 (sc) Injection, SHR-1316 Injection, Carboplatin Injection, Etoposide Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1316 (sc) InjectionDrug
SHR-1316 (sc) injection.
SHR-1316 InjectionDrug
SHR-1316 injection.
Carboplatin InjectionDrug
Carboplatin injection.
Etoposide InjectionDrug
Etoposide injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1316 (sc) Dose A Group | Experimental | Not described Receives: Drug: SHR-1316 (sc) Injection; Drug: SHR-1316 Injection; Drug: Carboplatin Injection; Drug: Etoposide Injection |
| SHR-1316 (sc) Dose B Group | Experimental | Not described Receives: Drug: SHR-1316 (sc) Injection; Drug: SHR-1316 Injection; Drug: Carboplatin Injection; Drug: Etoposide Injection |
| SHR-1316 (sc) Dose C Group | Experimental | Not described Receives: Drug: SHR-1316 (sc) Injection; Drug: SHR-1316 Injection; Drug: Carboplatin Injection; Drug: Etoposide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SHR-1316 serum trough concentration (Ctrough)
Measured: Day1 pre-dose to Day28.
Area under the concentration curve from time 0 to 21 days for SHR-1316 (sc) (AUC0-21d)
Measured: Day1 pre-dose to Day21.
Area under the concentration curve from time 0 to 28 days for SHR-1316 (sc) (AUC0-28d)
Measured: Day1 pre-dose to Day28.
Secondary outcomes (9)
Maximum Concentration of SHR-1316 (sc) (Cmax)
Measured: Day1 pre-dose to Day28.
Time to maximum plasma concentration (Tmax)
Measured: Day1 pre-dose to Day28.
Terminal half-life (t1/2)
Measured: Day1 pre-dose to Day28.
Incidence and severity of adverse events (AEs)
Measured: About 2 years.
Objective Response Rate (ORR)
Measured: About 2 years.
Duration of Relief (DoR)
Measured: About 1.5 years.
Disease Control Rate (DCR)
Measured: About 2 years.
Progression-free Survival (PFS)
Measured: About 2 years.
Overall Survival (OS)
Measured: About 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start16 Jun 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Widespread 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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
- NCT07009457
- Sponsor's protocol ID
- SHR-1316(sc)-101
- Status last verified
- Jun 2026
- First submitted
- 29 May 2025
- Last updated
- 30 Jun 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Phase I Clinical Study on the Pharmacokinetics, Safety, Tolerability, and Efficacy of SHR-1316 (SC) Combined With Carboplatin and Etoposide in First-line Treatment of Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07009457
- Acronym / sponsor ID
- SHR-1316(sc)-101
- Conditions
- Widespread Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 6 Jun 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 multicenter, open label phase I clinical trial aimed at evaluating the pharmacokinetics, tolerability, safety and immunogenicity of SHR-1316 (sc) subcutaneous administration combined with carboplatin and etoposide as first-line treatment for extensive stage small cell lung cancer, and to observe the initial anti-tumor efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR-1316 (sc) Dose A Group | Experimental | Drug: SHR-1316 (sc) Injection, Drug: SHR-1316 Injection, Drug: Carboplatin Injection, Drug: Etoposide Injection |
| SHR-1316 (sc) Dose B Group | Experimental | Drug: SHR-1316 (sc) Injection, Drug: SHR-1316 Injection, Drug: Carboplatin Injection, Drug: Etoposide Injection |
| SHR-1316 (sc) Dose C Group | Experimental | Drug: SHR-1316 (sc) Injection, Drug: SHR-1316 Injection, Drug: Carboplatin Injection, Drug: Etoposide Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with extensive stage small cell lung cancer confirmed by histology or cytology; Has not received first-line systemic therapy or immune checkpoint inhibitor treatment for ES-SCLC in the past.
- ECOG physical fitness score 0-1 points.
- According to RECIST v1.1, there must be at least one measurable tumor lesion.
- Expected survival time ≥ 12 weeks.
- Having sufficient bone marrow and organ function.
Key exclusion criteria (10 listed)
- Patients with central nervous system or meningeal metastases.
- Spinal cord compression that cannot be cured by surgery and/or radiotherapy cannot be included in the study.
- Patients diagnosed by researchers with uncontrollable tumor related pain.
- Symptomatic third space effusion requires repeated drainage, such as pericardial effusion, pleural effusion, and abdominal effusion that cannot be controlled by pumping or other treatments.
- Having undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first use of the investigational drug, or requiring elective surgery during the trial period.
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-1316 (sc) InjectionSHR-1316 (sc) injection. | Drug | SHR-1316 (sc) Dose A Group, SHR-1316 (sc) Dose B Group, SHR-1316 (sc) Dose C Group |
| SHR-1316 InjectionSHR-1316 injection. | Drug | SHR-1316 (sc) Dose A Group, SHR-1316 (sc) Dose B Group, SHR-1316 (sc) Dose C Group |
| Carboplatin InjectionCarboplatin injection. | Drug | SHR-1316 (sc) Dose A Group, SHR-1316 (sc) Dose B Group, SHR-1316 (sc) Dose C Group |
| Etoposide InjectionEtoposide injection. | Drug | SHR-1316 (sc) Dose A Group, SHR-1316 (sc) Dose B Group, SHR-1316 (sc) Dose C Group |
Primary outcome
SHR-1316 serum trough concentration (Ctrough)
Time frame: Day1 pre-dose to Day28.
Area under the concentration curve from time 0 to 21 days for SHR-1316 (sc) (AUC0-21d)
Time frame: Day1 pre-dose to Day21.
Area under the concentration curve from time 0 to 28 days for SHR-1316 (sc) (AUC0-28d)
Time frame: Day1 pre-dose to Day28.
9 secondary outcomes
Maximum Concentration of SHR-1316 (sc) (Cmax)
Time frame: Day1 pre-dose to Day28.
Time to maximum plasma concentration (Tmax)
Time frame: Day1 pre-dose to Day28.
Terminal half-life (t1/2)
Time frame: Day1 pre-dose to Day28.
Incidence and severity of adverse events (AEs)
Time frame: About 2 years.
Objective Response Rate (ORR)
Time frame: About 2 years.
Duration of Relief (DoR)
Time frame: About 1.5 years.
Disease Control Rate (DCR)
Time frame: About 2 years.
Progression-free Survival (PFS)
Time frame: About 2 years.
Overall Survival (OS)
Time frame: About 3 years.
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 30 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-1316 (sc) Injection, SHR-1316 Injection and Carboplatin Injection in people with Widespread 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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SHR-1316 serum trough concentration (Ctrough) (time frame: Day1 pre-dose to Day28.). 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 30 Jun 2026.