Small-cell Lung CancerPhase 3NCT04691063
The Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.
A Phase 3 study testing SHR-1316; Carboplatin; Etoposide；Radiotherapy and Palcebo; Carboplatin; Etoposide；Radiotherapy in people with Small-cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of SHR-1316 in combination with chemo-radiotherapy in patients with LS-SCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- SHR-1316; Carboplatin; Etoposide；Radiotherapy and Palcebo; Carboplatin; Etoposide；Radiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2021to 15 May 2025
- Phase
- Phase 3
- 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
- Male or female, 18-75 years of age.
- Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
- ECOG PS 0~1.
- At least 1 measurable lesion as defined by RECIST v1.1.
- Adequate organ function.
- Female subjects of childbearing potential or male subjects must be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug. And female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
- Signed the informed consent form.
Who cannot join
- Mixed SCLC or NSCLC.
- Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
- Extensive-stage SCLC.
- Subjects who is surgically resectable.
- Subjects with malignant pleural effusion.
- Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe diseases that seriously affect pulmonary function.
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- Active, known, or suspected autoimmune diseases.
- History of malignant tumors.
- Subjects with severe cardiovascular disease.
- Events of arterial/venous thrombosis within 6 months prior to the first dose.
- Subjects with serious infection.
- Subjects with active pulmonary tuberculosis (TB).
- Subjects with immunodeficiency diseases.
- Subjects with active hepatitis B virus or hepatitis C virus infection.
- Systemic immunosuppressants administation within 14 days prior to the first dose.
- Subjects who received major surgery within 28 days prior to the first dose.
- Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
- Subjects who have previously received tissue/organ transplants.
- Subjects with history of severe allergic reactions to monoclonal antibodies/fusion protein drugs.
- Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blinded, Phase III Trial of SHR-1316 or Placebo in Combination With Chemo-radiotherapy in Patients With Limited-stage Small-cell Lung Cancer.
The study is being conducted to evaluate the efficacy and safety of SHR-1316 in combination with chemo-radiotherapy in patients with LS-SCLC.
- Conditions
- Small-cell Lung Cancer
- Being tested
- SHR-1316; Carboplatin; Etoposide；Radiotherapy, Palcebo; Carboplatin; Etoposide；Radiotherapy
- 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-1316; Carboplatin; Etoposide；RadiotherapyDrug
SHR-1316; Carboplatin; Etoposide；Radiotherapy（Part 1 and Part 2）
Palcebo; Carboplatin; Etoposide；RadiotherapyDrug
Palcebo; Carboplatin; Etoposide；Radiotherapy（Part 2）
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR-1316; Carboplatin; Etoposide；Radiotherapy |
| Treatment group B | Placebo comparator | Not described Receives: Drug: Palcebo; Carboplatin; Etoposide；Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall Survival
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start22 Jan 2021
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-1316 in combination with chemo-radiotherapy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691063
- Sponsor's protocol ID
- SHR-1316-III-302
- Status last verified
- Dec 2020
- First submitted
- 25 Dec 2020
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blinded, Phase III Trial of SHR-1316 or Placebo in Combination With Chemo-radiotherapy in Patients With Limited-stage Small-cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT04691063
- Acronym / sponsor ID
- SHR-1316-III-302
- Conditions
- Small-cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 31 Dec 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.
The study is being conducted to evaluate the efficacy and safety of SHR-1316 in combination with chemo-radiotherapy in patients with LS-SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SHR-1316 in combination with chemo-radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-1316; Carboplatin; Etoposide；Radiotherapy |
| Treatment group B | Placebo comparator | Drug: Palcebo; Carboplatin; Etoposide；Radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 18-75 years of age.
- Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
- ECOG PS 0~1.
- At least 1 measurable lesion as defined by RECIST v1.1.
- Adequate organ function.
Key exclusion criteria (20 listed)
- Mixed SCLC or NSCLC.
- Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
- Extensive-stage SCLC.
- Subjects who is surgically resectable.
- Subjects with malignant pleural 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-1316; Carboplatin; Etoposide；RadiotherapySHR-1316; Carboplatin; Etoposide；Radiotherapy（Part 1 and Part 2） | Drug | Treatment group A |
| Palcebo; Carboplatin; Etoposide；RadiotherapyPalcebo; Carboplatin; Etoposide；Radiotherapy（Part 2） | Drug | Treatment group B |
Primary outcome
OS
Time frame: up to 36 months
Overall Survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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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 3 study testing SHR-1316; Carboplatin; Etoposide；Radiotherapy and Palcebo; Carboplatin; Etoposide；Radiotherapy in people with Small-cell Lung Cancer, run by Jiangsu HengRui Medicine 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 20 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 26 Feb 2021. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
OS (time frame: up to 36 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 26 Feb 2021.