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Small Cell Lung CancerPhase 3NCT04012606

Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer

A Phase 3 study of Small Cell Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase III, multicenter, double-blinded, placebo-controlled study of platinum（Cisplatin or Carboplatin） plus etoposide with or without toripalimab as first Line therapy in patients with extensive stage small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
442 participants
Where
1 siteChina
Study dates
23 Jul 2019to 20 Apr 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years , male or female;
  • Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system
  • ECOG PS 0~1;
  • No prior treatment or immunocheckpoint inhibitors for ES-SCLC;
  • Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC；
  • Patients with asymptomatic brain metastases who have received previous treatment
Show all 11Show fewer
  • Has provided tumor tissue samples
  • Estimated survival time ≥8 weeks;
  • There is at least one measurable lesion that conforms to RECIST criteria v1.1.For lesions that have received previous radiation therapy, the lesion can only be included in the measurable lesion if the disease progression is clear after radiotherapy and the lesion is not the only measurable lesion.
  • Before the first dose of the study drug, it should have appropriate organ function, and the laboratory test value should meet the protocol.
  • Has adequate hematologic and end organ function

Who cannot join

  • Prior systemtic treatment for ES-SCLC;
  • Prior treatment with any CD137 agnist or immunocheckpoint inhibitors.
  • Subjects with active or untreated central nervous system (CNS) tumor metastasis;
  • 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
  • Cancerous meningitis;
  • Uncontrolled or symptomatic hypercalcemia;
Show all 11Show fewer
  • Other malignant tumors within 5 years prior to the first dose of study treatment
  • Subjects with any active, known or suspected autoimmune disease;
  • History of idiopathic pulmonary fibrosis, drug-induced pneumonitis,or evidence of active pneumonitis .
  • Subjects who received major surgery within 28 days prior to enrollment or were not fully recovered from prior surgery;
  • Significant cardiovascular disease, such as New York Heart Assoc

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ying Cheng

    Changchun

Other trials in China

About this study

Official title: A Phase III Randomized, Double-Blind, Placebo-controlled Study of Platinum(Cisplatin or Carboplatin) Plus Etoposide With or Without Toripalimab as First Line Therapy in Patients With ExtensiveStage Small Cell Lung Cancer

This is a phase III, multicenter, double-blinded, placebo-controlled study of platinum（Cisplatin or Carboplatin） plus etoposide with or without toripalimab as first Line therapy in patients with extensive stage small cell lung cancer.

The purpose of this study is to evaluate the safety and efficacy of toriplimab in combination with platinum（Cisplatin or Carboplatin） plus etoposide in treatment naive extensive stage small cell lung cancer.

Participants will receive asigned study treatment until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

Being tested
TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin 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.

  • TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide PlaceboDrug

    TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.

Study groups in NCT04012606
Study groupRoleWhat they receive
TORIPALIMABExperimentalNot described
Receives: Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo
ChemotherapyActive comparatorNot described
Receives: Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo

What is being measured

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

  1. PFS (Progression Free Survival) by investigator

    Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)

    Measured: Approximately 2 years

  2. Overall suvival (OS)

    Overall suvival (OS)

    Measured: Approximately 2.8 years

Secondary outcomes (8)

  1. PFS (Progression Free Survival) per RECIST1.1 as Assessed by BIRC (Blinded Independent Review Board）

    PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria;

    Measured: Approximately 2 years

  2. ORR (Objective Response Rate)

    Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;

    Measured: Approximately 2 years

  3. DOR (Duration of Response)

    Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1;

    Measured: Approximately 2 years

  4. DCR (Disease of Response)

    Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1;

    Measured: Approximately 2 years

  5. TTR (Time to Response)

    Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1;

    Measured: Approximately 2 years

  6. OS (Overall Survival) rate

    OS rates at 1 and 2 years

    Measured: Approximately 2 years

  7. Incidence of AEs/SAEs

    Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0

    Measured: Approximately 2 years

  8. PFS (Progression Free Survival) Rate

    PFS rates at 6-month（inestigators and BICR） and at 1-year

    Measured: Approximately 1year

Timeline

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

  1. First posted9 Jul 2019
  2. Study start23 Jul 2019
  3. Primary completion20 Apr 2023
  4. Study completion20 Apr 2023

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
442 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04012606
Sponsor's protocol ID
JS001-028-III-SCLC
Status last verified
Jan 2025
First submitted
5 Jul 2019
Last updated
16 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cheng Y, Zhang W, Wu L, Zhou C, Wang D, Xia B, Bi M, Fu X, Li C, Lv D, Zhao Y, Chen G, Yi T, Huang J, Li M, Yang R, Huang X, Wang Y, Zhang M, Pan Y, Sun Y, Hu S, Zhang X, Zhou M, Fang J, Jin F, Liu Y, Li Y, Zhang Z, Hu J, Liu L, Wang R, Li Y, Gu K, Ding C, Fan Q, Zhang G, Chen Y, Jiang L, Zheng WE, Chen S, Huang C, Han Z, Yang H, Wang J, Wang B, Wu H, Bao Y, Li M, Luo X, Gu S, Yu W, Xu K, Zhang S, Yu J. Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: The Phase 3 EXTENTORCH Randomized Clinical Trial. JAMA Oncol. 2025 Jan 1;11(1):16-25. doi: 10.1001/jamaoncol.2024.5019.

    PubMed 39541202

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Small Cell Lung Cancer, run by Shanghai Junshi Bioscience 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 11 inclusion and 11 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: finished, as of the sponsor's last update on 16 Jan 2025. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

PFS (Progression Free Survival) by investigator (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. 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 NCT04012606, which also lists 1 linked publication.

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 16 Jan 2025.

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