Small Cell Lung Cancer Extensive StagePhase 2NCT06648200
Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer
A Phase 2 study testing JS004, Toripalimab and Etoposide in people with Small Cell Lung Cancer Extensive Stage and Small Cell Lung Cancer Recurrent, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Recurrent
- What is being tested?
- JS004, Toripalimab and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2024to 29 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient shall sign the Informed Consent Form;
- Aged 18 ≥ years;
- Histological or cytological diagnosis of SCLC by needle biopsy or EBUS, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment SCLC;
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
- Life expectancy is at least 12 weeks;
- At least 1 measurable lesion according to RECIST 1.1;
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- Patients with good function of other main organs (liver, kidney, blood system, etc.);
- Fertile female patients must voluntarily use effective contraceptives from the start of the trial to within 30 days after its completion, and urine or serum pregnancy test results within 7 days prior to enrollment are negative;
- Unsterilized male patients must voluntarily use effective contraception during the trial period and for 30 days after its conclusion.
Who cannot join
- Patients with a malignancy other than SCLC within five years prior to the start of this trial;
- Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
- With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
- Participants who are allergic to the test drug or any auxiliary materials;
- Participants with active hepatitis B, hepatitis C or HIV;
- Participants with Interstitial lung disease currently;
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- Pregnant or lactating women;
- Any malabsorption;
- Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
- Other factors that researchers think it is not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer: a Single-center, Randomized Trial
For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells; function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.
- Being tested
- JS004, Toripalimab, Etoposide, Platinum
- Keywords
- small cell lung cancer, Toripalimab, JS004, Extensive-stage, Recurrent
- Medical subject headings
- Small Cell Lung Carcinoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS004Drug
Also called tifcemalimab
Specified dose on specified days.
ToripalimabDrug
Specified dose on specified days.
EtoposideDrug
Specified dose on specified days.
PlatinumDrug
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy | Active comparator | In this arm, patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab until the disease progressed. Receives: Drug: Toripalimab; Drug: Etoposide; Drug: Platinum |
| Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy | Experimental | In this arm, patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab and JS004 combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab and JS004 until the disease progressed. Receives: Drug: JS004; Drug: Toripalimab; Drug: Etoposide; Drug: Platinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
It is defined as the time (months) from randomization to the first occurrence of disease progression according to RECIST 1.1 or death from any cause short of progression.
Measured: up to 60 months
Secondary outcomes (5)
Objective response rate (ORR)
ORR is defined according to the RECIST v1.1 criteria.
Measured: up to 30 months
Treatment-related adverse event (TRAE)
TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
Measured: Up to 30 months
Overall survival (OS)
It is defined as the time (months) from randomization to the death generated by any cause.
Measured: up to 60 months
Health related quality of life (HRQol)：EORTC-QLQ-C30
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 , Version 3). EORTC's QLQ-C30 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options.
Measured: up to 5 months
Health related quality of life (HRQol)：LC13
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (LC13, Version 3).The items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start18 Nov 2024
- Primary completion29 Aug 2026
- Study completion29 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer Extensive StageStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- All enrolled patients were randomly assigned to one of two groups. Patients in group 1 received toripalimab combined with etoposide and platinum Chemotherapy; patients in group 2 received toripalimab and JS004 combined with etoposide and platinum Chemotherapy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648200
- Sponsor's protocol ID
- LungMate-031
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers will consider whether IPD is available to other researchers only after the paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer: a Single-center, Randomized Trial
- ClinicalTrials.gov ID
- NCT06648200
- Acronym / sponsor ID
- LungMate-031
- Keywords
- small cell lung cancer, Toripalimab, JS004, Extensive-stage, Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 29 Aug 2026 (actual)
- Study completion
- 29 Aug 2026 (actual)
- First posted
- 18 Oct 2024 (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.
For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells; function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All enrolled patients were randomly assigned to one of two groups. Patients in group 1 received toripalimab combined with etoposide and platinum Chemotherapy; patients in group 2 received toripalimab and JS004 combined with etoposide and platinum Chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy | Active comparator | Drug: Toripalimab, Drug: Etoposide, Drug: PlatinumIn this arm, patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab until the disease progressed. |
| Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy | Experimental | Drug: JS004, Drug: Toripalimab, Drug: Etoposide, Drug: PlatinumIn this arm, patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab and JS004 combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab and JS004 until the disease progressed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient shall sign the Informed Consent Form;
- Aged 18 ≥ years;
- Histological or cytological diagnosis of SCLC by needle biopsy or EBUS, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment SCLC;
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
- Life expectancy is at least 12 weeks;
Key exclusion criteria (10 listed)
- Patients with a malignancy other than SCLC within five years prior to the start of this trial;
- Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
- With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
- Participants who are allergic to the test drug or any auxiliary materials;
- Participants with active hepatitis B, hepatitis C or HIV;
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 |
|---|---|---|
| JS004Also: tifcemalimabSpecified dose on specified days. | Drug | Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy |
| ToripalimabSpecified dose on specified days. | Drug | Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy, Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy |
| EtoposideSpecified dose on specified days. | Drug | Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy, Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy |
| PlatinumSpecified dose on specified days. | Drug | Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy, Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 60 months
It is defined as the time (months) from randomization to the first occurrence of disease progression according to RECIST 1.1 or death from any cause short of progression.
5 secondary outcomes
Objective response rate (ORR)
Time frame: up to 30 months
Treatment-related adverse event (TRAE)
Time frame: Up to 30 months
Overall survival (OS)
Time frame: up to 60 months
Health related quality of life (HRQol)：EORTC-QLQ-C30
Time frame: up to 5 months
Health related quality of life (HRQol)：LC13
Time frame: up to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided. The researchers will consider whether IPD is available to other researchers only after the paper is published.
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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 2 study testing JS004, Toripalimab and Etoposide in people with Small Cell Lung Cancer Extensive Stage and Small Cell Lung Cancer Recurrent, run by Shanghai Pulmonary Hospital, Shanghai, China 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 9 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: finished, as of the sponsor's last update on 15 Oct 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 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?
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?
Progression-free survival (PFS) (time frame: up to 60 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 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.