Limited-stage Small Cell Lung Cancer, LS-SCLCPhase 2NCT04647357
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer
A Phase 2 study testing SHR-1316 in people with Limited-stage Small Cell Lung Cancer, LS-SCLC, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy 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, LS-SCLC
- What is being tested?
- SHR-1316
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 27 Nov 2020to 27 Dec 2023
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is 18-75 years old (including both ends), regardless of gender;
- Histologically confirmed limited stage small cell lung cancer ;
- ECOG PS 0 ~ 1;
- Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication.
- The last chemotherapy must be finished before or at the same time of radiotherapy.
- The disease did not progress after concurrent chemoradiotherapy;
- The expected survival time was more than 3 months;
- Pulmonary function: FEV1 > 70%;
Who cannot join
- The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
- Mixed SCLC or NSCLC confirmed by histology;
- Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;
- Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;
- Extensive SCLC;
- Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery);
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- Interstitial pneumonia
- History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
- HIV, active Hepatitis B or Hepatitis C infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment
SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy
- Being tested
- 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-1316Drug
Anti-PD-L1 antibody，Maintenance therapy, The drug was administered every three weeks
| Study group | Role | What they receive |
|---|---|---|
| SHR-1316 | Experimental | Not described Receives: Drug: SHR-1316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start27 Nov 2020 (estimated)
- Primary completion27 May 2023 (estimated)
- Study completion27 Dec 2023 (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 Cancer, LS-SCLCStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaorong Dong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647357
- Sponsor's protocol ID
- LS-SCLC-MT-IIT-SHR1316
- Status last verified
- Nov 2020
- First submitted
- 27 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment
- ClinicalTrials.gov ID
- NCT04647357
- Acronym / sponsor ID
- LS-SCLC-MT-IIT-SHR1316
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 27 Nov 2020 (estimated)
- Primary completion
- 27 May 2023 (estimated)
- Study completion
- 27 Dec 2023 (estimated)
- First posted
- 30 Nov 2020 (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.
SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1316 | Experimental | 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 (8 listed)
- The age is 18-75 years old (including both ends), regardless of gender;
- Histologically confirmed limited stage small cell lung cancer ;
- ECOG PS 0 ~ 1;
- Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication.
- The last chemotherapy must be finished before or at the same time of radiotherapy.
Key exclusion criteria (9 listed)
- The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
- Mixed SCLC or NSCLC confirmed by histology;
- Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;
- Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;
- Extensive SCLC;
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-1316Anti-PD-L1 antibody，Maintenance therapy, The drug was administered every three weeks | Drug | SHR-1316 |
Primary outcome
PFS
Time frame: Up to approximately 24 months
progression-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1316 in people with Limited-stage Small Cell Lung Cancer, LS-SCLC, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 8 inclusion and 9 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 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaorong Dong, PhD (027-85872859, xiaorongdong@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to approximately 24 months). 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 Nov 2020.