ES-SCLCPhase 2NCT07349225
Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy and Sequential Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing Iparomlimab and Tuvonralimab Injection, Etoposide and Cisplatin in people with ES-SCLC, run by The Second Affiliated Hospital of Dalian Medical University.
Trial summary
This study will evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection in combination with Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ES-SCLC
- What is being tested?
- Iparomlimab and Tuvonralimab Injection, Etoposide and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 28 Feb 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For voluntary signing of the informed consent form, participants aged 18 to 75 years (inclusive), regardless of gender, are eligible
- Histologically or cytologically confirmed ES-SCLC (according to the Veterans Administration Lung Study Group [VALG] staging system)
- Expected survival ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- No prior systemic first-line therapy or immune checkpoint inhibitor treatment for ES-SCLC
- Prior treatment with curative-intent surgery and adjuvant therapy (e.g., radiotherapy or chemotherapy), with a treatment-free interval of at least 6 months between the last dose of chemotherapy/radiotherapy/chemoradiotherapy and the diagnosis of ES-SCLC
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- According to RECIST v1.1 (Appendix 2), previously irradiated lesions can only be considered measurable if there is documented disease progression at that site after radiotherapy, and such lesions must not be the sole site of disease
- Laboratory test results must meet the following criteria prior to enrollment: a) Hematology: No blood transfusion or hematopoietic growth factor administration within 14 days before enrollment; white blood cell count (WBC) ≥3.0×10^9/L; absolute neutrophil count (ANC) ≥1.5×10^9/L; platelets (PLT) ≥100×10^9/L; hemoglobin (HGB) ≥9.0 g/dL. b) Liver function: Non-liver metastasis subjects: Aspartate aminotransferase (AST) ≤2.5×ULN and alanine aminotransferase (ALT) ≤2.5×ULN. Liver metastasis subjects: ALT and AST ≤5×ULN; serum total bilirubin (TBIL) ≤1.5×ULN (except Gilbert syndrome, where TBIL ≤3.0 mg/dL). c) Renal function: Serum creatinine ≤1.5×ULN or calculated creatinine clearance (CrCl) ≥50 mL/min (using the Cockcroft-Gault formula in Appendix 3). d) Coagulation: International normalized ratio (INR) ≤1.5×ULN or activated partial thromboplastin time (APTT) ≤1.5×ULN (only for subjects not receiving anticoagulation therapy; subjects on stable-dose anticoagulants are eligible). e) Other tests confirming adequate cardiopulmonary function
- Male patients with reproductive potential or female patients of childbearing potential must use effective contraception (e.g., oral contraceptives, intrauterine devices, or barrier methods combined with spermicides) during the study and continue for 6 months after treatment completion
- For patients with HBV or HCV infection, the following criteria must be met: HBV-infected patients (HBsAg or HBV-DNA positive): Prior to the first treatment, HBV-infected patients must receive ≥3 days of guideline-recommended antiviral therapy with confirmed reduction in HBV-DNA levels upon retesting . Standard antiviral treatment must continue throughout the study period . HCV-infected subjects (HCVAb or HCV RNA positive): Must be in a stable condition as judged by the investigator. If already on antiviral therapy, treatment should be maintained during the study
- Good compliance and cooperation with follow-up
Who cannot join
- Patients with allergies or intolerance to the EP chemoradiotherapy regimen or any active/auxiliary components of the investigational drug
- Active or untreated central nervous system (CNS) metastases identified by computed tomography (CT) or magnetic resonance imaging (MRI) during screening or prior radiographic assessments
- Malignant effusions (pleural/ascites/pericardial) refractory to prior interventions (Defined as significant reaccumulation requiring repeat drainage or other interventions within 2 weeks, accompanied by symptomatic worsening)
- Active autoimmune diseases , including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), antiphospholipid syndrome, granulomatosis with polyangiitis (Wegener's), Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis (MS)
- Uncontrolled hypertension despite treatment with ≥1 antihypertensive agent(s) (Defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg, based on the average of ≥2 BP readings, despite ongoing antihypertensive therapy. Adjustment of treatment to improve these parameters is permitted.)
- Moderate-to-severe pulmonary diseases that significantly impair lung function , including but not limited to interstitial lung disease (ILD), drug-induced pneumonitis, idiopathic pneumonia, or idiopathic pulmonary fibrosis (IPF)
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- Patients with active tuberculosis infection confirmed by medical history or CT examination, or those with a history of active tuberculosis infection within 1 year prior to enrollment
- Severe infections within 4 weeks prior to initial treatment , including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia
- Severe cardiovascular or cerebrovascular diseases within 3 months prior to initial treatment , including myocardial infarction, cerebrovascular accident, unstable arrhythmia, or unstable angina
- History of allogeneic bone marrow transplantation or solid organ transplantation
- Prior treatment with immune checkpoint inhibitors (ICIs) , including but not limited to anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents
- Use of systemic immunosuppressive therapy within 2 weeks prior to initial treatment , or anticipated need for systemic immunosuppressive therapy during the study treatment period
- Participation in any other interventional clinical study or use of any other investigational product within 4 weeks prior to signing the informed consent form
- History of abdominal or tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 1 month prior to initial treatment
- Major vascular disease occurring within 3 months prior to initial treatment (e.g., aortic aneurysm requiring surgical repair)
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study
- Positive for human immunodeficiency virus (HIV) antibody
- History of schizophrenia or psychotropic drug abuse
- Other factors considered by the investigator to make the subject unsuitable for participation in the 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 Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
This study will evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection in combination with Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer.
Read the detailed description
This is a prospective, single-arm, multicenter clinical study assessing the efficacy and safety of Iparomlimab and Tuvonralimab Injection in combination with Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer. As well as, this study aimed to longitudinally monitor the dynamic changes of molecular residual disease in patients with extensive-stage small cell lung cancer to evaluate treatment efficacy and explore the potential application value of MRD as a biomarker for efficacy assessment.
- Conditions
- ES-SCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab InjectionDrug
Induction Therapy: Ipilimumab and tuvonralimab injection, 5 mg/kg, Day 1, every 3 weeks for 4 to 6 cycles.
Maintenance therapy: Ipilimumab and tuvonralimab injection, 5 mg/kg, Day 1, every 3 weeks. Maintenance therapy was continued for up to 2 years or until disease progression (PD), intolerable toxicity, withdrawal of informed consent, investigator-determined subject discontinuation from the study, non-compliance with study treatment or procedures, or other reasons specified in the protocol.
EtoposideDrug
Induction Therapy: etoposide, 100 mg/m2, D1-3, every 3 weeks for 4 to 6 cycles.
CisplatinDrug
Induction Therapy: cisplatin, 25 mg/m², D1-3, every 3 weeks for 4 to 6 cycles.
Targeted Radiation TherapyRadiation
Subjects who achieved a CR, PR, or SD with good local control following induction therapy, were subjected to sequential TRT (≥3Gy×10 or 15, using an involved-field irradiation technique. The specific regimen could be adjusted according to the patient's disease status and the standard practices of the investigator's institutional radiation oncology department)
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab Injection Combined with EP and Sequential Thoracic Radiotherapy | Experimental | Subjects first underwent induction therapy, receiving 4 to 6 cycles of Iparomlimab and Tuvonralimab Injection combined with etoposide and cisplatin. Upon completion of treatment, imaging evaluation was performed. Subjects who achieved a response of CR, PR, or SD with good local control proceeded to receive sequential thoracic radiotherapy (TRT), followed by maintenance therapy with Iparomlimab and Tuvonralimab Injection as a single agent. Receives: Drug: Iparomlimab and Tuvonralimab Injection; Drug: Etoposide; Drug: Cisplatin; Radiation: Targeted Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
PFS was defined as the time from the first administration of the study drug to the first occurrence of objective tumor progression or death from any cause, whichever occurred first.
Measured: 1 year
Secondary outcomes (5)
Objective Response Rate
ORR was defined as the proportion of patients whose best observed response from the first administration of the study drug until the first objective tumor progression was either CR (Complete Response) or PR (Partial Response).
Measured: 1 year
Disease Control Rate
DCR was defined as the proportion of patients whose best observed response from the first administration of the study drug until the first objective tumor progression was CR, PR, or SD (Stable Disease).
Measured: 1 year
Duration of Response
The time from the date of the first tumor assessment documenting CR or PR to the date of the first assessment documenting PD (Progressive Disease) or death from any cause, whichever occurred first, during the study treatment period.
Measured: 1 year
Thoracic Local Control Rate
Defined as the proportion of patients who maintained control of the primary thoracic tumor and regional lymph nodes from the initiation of thoracic radiotherapy (TRT).
Measured: 1 year
Overall Survival
The time from the first administration of the study drug to death from any cause.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ES-SCLCStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349225
- Sponsor's protocol ID
- QL-RE1-25001
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07349225
- Acronym / sponsor ID
- QL-RE1-25001
- Conditions
- ES-SCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 16 Jan 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 will evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection in combination with Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer.
Detailed description
This is a prospective, single-arm, multicenter clinical study assessing the efficacy and safety of Iparomlimab and Tuvonralimab Injection in combination with Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer. As well as, this study aimed to longitudinally monitor the dynamic changes of molecular residual disease in patients with extensive-stage small cell lung cancer to evaluate treatment efficacy and explore the potential application value of MRD as a biomarker for efficacy assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and Tuvonralimab Injection Combined with EP and Sequential Thoracic Radiotherapy | Experimental | Drug: Iparomlimab and Tuvonralimab Injection, Drug: Etoposide, Drug: Cisplatin, Radiation: Targeted Radiation TherapySubjects first underwent induction therapy, receiving 4 to 6 cycles of Iparomlimab and Tuvonralimab Injection combined with etoposide and cisplatin. Upon completion of treatment, imaging evaluation was performed. Subjects who achieved a response of CR, PR, or SD with good local control proceeded to receive sequential thoracic radiotherapy (TRT), followed by maintenance therapy with Iparomlimab and Tuvonralimab Injection as a single agent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For voluntary signing of the informed consent form, participants aged 18 to 75 years (inclusive), regardless of gender, are eligible
- Histologically or cytologically confirmed ES-SCLC (according to the Veterans Administration Lung Study Group [VALG] staging system)
- Expected survival ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- No prior systemic first-line therapy or immune checkpoint inhibitor treatment for ES-SCLC
Key exclusion criteria (19 listed)
- Patients with allergies or intolerance to the EP chemoradiotherapy regimen or any active/auxiliary components of the investigational drug
- Active or untreated central nervous system (CNS) metastases identified by computed tomography (CT) or magnetic resonance imaging (MRI) during screening or prior radiographic assessments
- Malignant effusions (pleural/ascites/pericardial) refractory to prior interventions (Defined as significant reaccumulation requiring repeat drainage or other interventions within 2 weeks, accompanied by symptomatic worsening)
- Active autoimmune diseases , including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), antiphospholipid syndrome, granulomatosis with polyangiitis (Wegener's), Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis (MS)
- Uncontrolled hypertension despite treatment with ≥1 antihypertensive agent(s) (Defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg, based on the average of ≥2 BP readings, despite ongoing antihypertensive therapy. Adjustment of treatment to improve these parameters is permitted.)
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 |
|---|---|---|
| Iparomlimab and Tuvonralimab InjectionInduction Therapy: Ipilimumab and tuvonralimab injection, 5 mg/kg, Day 1, every 3 weeks for 4 to 6 cycles. Maintenance therapy: Ipilimumab and tuvonralimab injection, 5 mg/kg, Day 1, every 3 weeks. Maintenance therapy was continued for up to 2 years or until disease progression (PD), intolerable toxicity, withdrawal of informed consent, investigator-determined subject discontinuation from the study, non-compliance with study treatment or procedures, or other reasons specified in the protocol. | Drug | Iparomlimab and Tuvonralimab Injection Combined with EP and Sequential Thoracic Radiotherapy |
| EtoposideInduction Therapy: etoposide, 100 mg/m2, D1-3, every 3 weeks for 4 to 6 cycles. | Drug | Iparomlimab and Tuvonralimab Injection Combined with EP and Sequential Thoracic Radiotherapy |
| CisplatinInduction Therapy: cisplatin, 25 mg/m², D1-3, every 3 weeks for 4 to 6 cycles. | Drug | Iparomlimab and Tuvonralimab Injection Combined with EP and Sequential Thoracic Radiotherapy |
| Targeted Radiation TherapySubjects who achieved a CR, PR, or SD with good local control following induction therapy, were subjected to sequential TRT (≥3Gy×10 or 15, using an involved-field irradiation technique. The specific regimen could be adjusted according to the patient's disease status and the standard practices of the investigator's institutional radiation oncology department) | Radiation | Iparomlimab and Tuvonralimab Injection Combined with EP and Sequential Thoracic Radiotherapy |
Primary outcome
Progression-Free Survival
Time frame: 1 year
PFS was defined as the time from the first administration of the study drug to the first occurrence of objective tumor progression or death from any cause, whichever occurred first.
5 secondary outcomes
Objective Response Rate
Time frame: 1 year
Disease Control Rate
Time frame: 1 year
Duration of Response
Time frame: 1 year
Thoracic Local Control Rate
Time frame: 1 year
Overall Survival
Time frame: 1 year
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 16 Jan 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 Iparomlimab and Tuvonralimab Injection, Etoposide and Cisplatin in people with ES-SCLC, run by The Second Affiliated Hospital of Dalian Medical University.
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 19 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 16 Jan 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 jincheng SONG, DR (+86 17709873393, 601253811@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 1 year). 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 16 Jan 2026.