SCLC, Extensive StagePhase 2NCT07698054
Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer
A Phase 2 study testing Toripalimab; Etoposide in people with SCLC, Extensive Stage and Bayesian, run by Henan Cancer Hospital.
Trial summary
This study is a randomized, open-label, multi-center investigator-initiated clinical trial. Patients who meet the inclusion criteria receive the treatment plan stipulated in the protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC, Extensive Stage, Bayesian, Metronomic Chemotherapy
- What is being tested?
- Toripalimab; Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 1.Age ≥18 years old, both male and female are acceptable.
- 2. Histology and pathology diagnosis of extensive stage small cell lung cancer, and must meet the following standards:
- always has not received the immune therapy,
- Previously received immunotherapy, with the number of treatment lines ≥2 and the immunotherapy being effective(immunotherapy PFS > 3 months, withdrawal time > 3 months)
- never used anlotinib,
- 3. ECOG: 0 ~ 2;
- 4 . The expected lifetime 12 weeks or more;
- 5. Major organs function normal
Who cannot join
- 1.Those who are allergic to toripalimab or etoposide or have metabolic disorders;
- 2.With known the special ripley sheet resistance, etoposide contraindication;
- 3.Other circumstances that the researcher assessed as unsuitable for participation in this clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Open-label, Bayesian Adaptive Randomized Phase II Clinical Study of Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer
This study is a randomized, open-label, multi-center investigator-initiated clinical trial. Patients who meet the inclusion criteria receive the treatment plan stipulated in the protocol. A Bayesian design is used to explore the efficacy and safety of teprotumumab combined with pulse chemotherapy in the treatment of advanced second-line extensive-stage small cell lung cancer.
- Conditions
- SCLC, Extensive Stage, Bayesian, Metronomic Chemotherapy
- Being tested
- Toripalimab; Etoposide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab; EtoposideDrug
Also called Etoposide；, carboplatin, temozolomide, Anlotinib
Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； carboplatin: AUC=5，d1， ivgtt,， Q3W； temozolomide:75mg/m2/d，d1-d21，PO，Q4W; Anlotinib:12mg，d1-d14 PO，Q3W
| Study group | Role | What they receive |
|---|---|---|
| Etoposide | Experimental | Etoposide: PO, 50 mg, d1-d14, Q3W Receives: Drug: Toripalimab; Etoposide |
| Etoposide+Toripalimab | Experimental | Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Receives: Drug: Toripalimab; Etoposide |
| Toripalimab+Etoposide+Anlotinib | Experimental | Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Anlotinib: 12mg, d1-d14, PO, Q3W; Receives: Drug: Toripalimab; Etoposide |
| Toripalimab+Etoposide+Carboplatin | Experimental | Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Carboplatin: AUC=5, d1, ivgtt, Q3W Receives: Drug: Toripalimab; Etoposide |
| Etoposide+Toripalimab+Temozolomide | Experimental | Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Temozolomide: 75mg/m ² /d, d1-d21, PO, Q4W; Receives: Drug: Toripalimab; Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
According to the RECIST 1.1 standard, the proportion of patients whose tumors have shrunk to a complete response (CR) or partial response (PR) and have maintained this condition for at least 4 weeks
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Extensive StageStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698054
- Sponsor's protocol ID
- SCLC-IIT-JS001-SA01
- Status last verified
- Apr 2026
- First submitted
- 6 May 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Bayesian Adaptive Randomized Phase II Clinical Study of Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07698054
- Acronym / sponsor ID
- SCLC-IIT-JS001-SA01
- Conditions
- SCLC, Extensive Stage, Bayesian, Metronomic Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Jul 2026 (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.
This study is a randomized, open-label, multi-center investigator-initiated clinical trial. Patients who meet the inclusion criteria receive the treatment plan stipulated in the protocol. A Bayesian design is used to explore the efficacy and safety of teprotumumab combined with pulse chemotherapy in the treatment of advanced second-line extensive-stage small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Etoposide | Experimental | Drug: Toripalimab; EtoposideEtoposide: PO, 50 mg, d1-d14, Q3W |
| Etoposide+Toripalimab | Experimental | Drug: Toripalimab; EtoposideToripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； |
| Toripalimab+Etoposide+Anlotinib | Experimental | Drug: Toripalimab; EtoposideToripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Anlotinib: 12mg, d1-d14, PO, Q3W; |
| Toripalimab+Etoposide+Carboplatin | Experimental | Drug: Toripalimab; EtoposideToripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Carboplatin: AUC=5, d1, ivgtt, Q3W |
| Etoposide+Toripalimab+Temozolomide | Experimental | Drug: Toripalimab; EtoposideToripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Temozolomide: 75mg/m ² /d, d1-d21, PO, Q4W; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1.Age ≥18 years old, both male and female are acceptable.
- 2. Histology and pathology diagnosis of extensive stage small cell lung cancer, and must meet the following standards:
- 3. ECOG: 0 ~ 2;
- 4 . The expected lifetime 12 weeks or more;
- 5. Major organs function normal
Key exclusion criteria (3 listed)
- 1.Those who are allergic to toripalimab or etoposide or have metabolic disorders;
- 2.With known the special ripley sheet resistance, etoposide contraindication;
- 3.Other circumstances that the researcher assessed as unsuitable for participation in this clinical study.
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 |
|---|---|---|
| Toripalimab; EtoposideAlso: Etoposide；, carboplatin, temozolomide, AnlotinibToripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； carboplatin: AUC=5，d1， ivgtt,， Q3W； temozolomide:75mg/m2/d，d1-d21，PO，Q4W; Anlotinib:12mg，d1-d14 PO，Q3W | Drug | Etoposide, Etoposide+Toripalimab, Etoposide+Toripalimab+Temozolomide, Toripalimab+Etoposide+Anlotinib, Toripalimab+Etoposide+Carboplatin |
Primary outcome
ORR
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
According to the RECIST 1.1 standard, the proportion of patients whose tumors have shrunk to a complete response (CR) or partial response (PR) and have maintained this condition for at least 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab; Etoposide in people with SCLC, Extensive Stage and Bayesian, run by Henan Cancer Hospital.
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 3 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: opening soon, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiming Wang (4000371818, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 13 Jul 2026.