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Extensive-stage Small Cell Lung CancerPhase 3NCT03711305

Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

A Phase 3 study testing SHR-1316, Carboplatin and Etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized, double-blinded, placebo-controlled phase III, multicenter study is designed to evaluate the safety and efficacy of SHR-1316 in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Extensive-stage Small Cell Lung Cancer
What is being tested?
SHR-1316, Carboplatin and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
462 participants
Where
2 sitesChina
Study dates
30 Dec 2018to Dec 2023
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

  • Age >= 18 years and <= 75 years
  • Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • No prior systemic treatment or immune checkpoint inhibitor treatment for ES-SCLC
  • At least 6 months treatment-free period since last chemo/radiotherapy with curative intent for limited-stage SCLC
  • Measurable disease, as defined by RECIST v1.1
Show all 23Show fewer
  • Adequate hematologic and end organ function
  • Patients must submit a pre-treatment tumor tissue sample during the study.
  • Signed inform consent form
  • Exclusion Criteria:• Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
  • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
  • Leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled or symptomatic hypercalcemia
  • Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • History of autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease
  • Prior treatment with immune checkpoint blockade therapies
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
  • Significant cardiovascular disease
  • Prior allogeneic bone marrow transplantation or solid organ transplant
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to randomization
  • History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin or etoposide
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • Jilin Cancer Hospital

    Jilin City, Changchun

Other trials in China

About this study

Official title: Randomized, Double-blinded, Placebo Controlled, Multicenter, Phase III Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

This randomized, double-blinded, placebo-controlled phase III, multicenter study is designed to evaluate the safety and efficacy of SHR-1316 in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.

Read the detailed description

Participants will be randomized in a 1:1 ratio to receive either SHR-1316 + carboplatin + etoposide or placebo + carboplatin + etoposide for 4-6 cycles in the induction phase followed by maintenance with SHR-1316 or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or or unacceptable toxicity.

Being tested
SHR-1316, Carboplatin, Etoposide, Placebo
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

    SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.

  • CarboplatinDrug

    Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

  • EtoposideDrug

    Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

  • PlaceboDrug

    Placebo intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.

Study groups in NCT03711305
Study groupRoleWhat they receive
SHR-1316 + carboplatin + etoposideExperimentalParticipants will receive SHR-1316 intravenously in combination with carboplatin and etoposide during the induction phase (Cycles 1-4 or 6). Thereafter, participants will receive maintenance (after induction phase) SHR-1316 until persistent radiographic PD, intolerable toxicity or withdrawal of consent.
Receives: Drug: SHR-1316; Drug: Carboplatin; Drug: Etoposide
Placebo + carboplatin + etoposideActive comparatorParticipants will receive placebo intravenously in combination with carboplatin and etoposide during the induction phase (Cycles 1-4 or 6). Thereafter, participants will receive maintenance (after induction phase) placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent.
Receives: Drug: Carboplatin; Drug: Etoposide; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Overall Survival (OS)

    Baseline until death from any cause

    Measured: up to approximately 31 months

Secondary outcomes (6)

  1. Duration of Progression-Free Survival (PFS) as Assessed Using RECIST v1.1

    Measured: up to approximately 6 months

  2. Percentage of Participants With Objective Response (OR) as Assessed by the Investigator Using RECIST v1.1

    Baseline until partial response (PR) or complete response (CR), whichever occurs first

    Measured: up to approximately 31 months

  3. Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

    First occurrence of PR or CR until PD or death, whichever occurs first

    Measured: up to approximately 31 months

  4. Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 1 Year

    Measured: 6 months, 1 year

  5. Percentage of Participants Alive at 1 Year and 2 Years

    Measured: 1 year, 2 years

  6. Percentage of Participants with Adverse Events Or Serious Adverse Events.

    Measured: up to approximately 31 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start30 Dec 2018
  3. Primary completionOct 2022 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
462 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03711305
Sponsor's protocol ID
SHR-1316-III-301
Status last verified
Apr 2022
First submitted
16 Oct 2018
Last updated
18 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Long Y, Wang H, Xie X, Li J, Xu Y, Zhou Y. Updated cost-effectiveness analysis of adebrelimab plus chemotherapy for extensive-stage small cell lung cancer in China. BMJ Open. 2024 Apr 5;14(4):e077090. doi: 10.1136/bmjopen-2023-077090.

    PubMed 38582540

  • Wang J, Zhou C, Yao W, Wang Q, Min X, Chen G, Xu X, Li X, Xu F, Fang Y, Yang R, Yu G, Gong Y, Zhao J, Fan Y, Liu Q, Cao L, Yao Y, Liu Y, Li X, Wu J, He Z, Lu K, Jiang L, Hu C, Zhao W, Zhang B, Shi W, Zhang X, Cheng Y; CAPSTONE-1 Study Group. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Jun;23(6):739-747. doi: 10.1016/S1470-2045(22)00224-8. Epub 2022 May 13.

    PubMed 35576956

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR-1316, Carboplatin and Etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 23 inclusion and 0 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 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

Duration of Overall Survival (OS) (time frame: up to approximately 31 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03711305, which also lists 2 linked publications.

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 18 Apr 2022.

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