Limited-stage Small Cell Lung Cancer (LS-SCLC)Phase 2NCT07091305
A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy
A Phase 2 study testing QL1706 (bispecific antibody targeting PD-1 and CLTA-4) in people with Limited-stage Small Cell Lung Cancer (LS-SCLC) and Chemoradiotherapy, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The study is being conducted to evaluation of the Efficacy and Safety of QL1706 Combined with Chemotherapy Induction in Sequential Immunotherapy Consolidation After Concurrent Chemoradiotherapy for Limited-Stage Small Cell Lung Cancer(LS-SCLC), and Exploration of the Correlation Between Biomarkers (PD-L1, TMB, ctDNA… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Limited-stage Small Cell Lung Cancer (LS-SCLC), Chemoradiotherapy, Induction Therapy
- What is being tested?
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2025to 1 Aug 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
- The patient must be aged between 18 and 75 years (inclusive of boundary values), and both males and females are eligible.
- Pathologically confirmed LS-SCLC
- Investigator confirmation of at least one measurable lesion, as defined by RECIST v1.1
- ECOG performance status of 0 or 1
- Forced expiratory volume in one second (FEV₁) > 1.0 L
- No clinically significant interstitial lung disease on baseline CT or PET/CT.
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- Adequate organ and bone-marrow function (all tests performed within 7 days prior to first dose; no transfusions, growth factors, albumin, or other corrective therapies within 14 days):Hemoglobin ≥ 90 g/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 90 × 10⁹/L,Serum creatinine ≤ 1.5 × ULN, TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Albumin (ALB) ≥ 25 g/L,INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN (subjects on prophylactic anticoagulation must have values within a safe therapeutic range, per investigator)
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use reliable contraception from screening until 3 months after the last dose; male subjects must agree to use effective contraception or have undergone surgical sterilization for the same period.
- No prior systemic anti-tumor therapy before enrollment.
- Estimated life expectancy ≥ 12 weeks.
Who cannot join
- Known hypersensitivity to QL1706 or any of its excipients
- Histologically confirmed non-small cell lung cancer (NSCLC) or mixed tumor containing an NSCLC component.
- History of another primary malignancy or previous allogeneic organ transplantation.
- Surgery (other than diagnostic biopsy) within 4 weeks before first dose of study drug.
- Active substance abuse (e.g., illicit drug use), chronic alcoholism, AIDS, or known HIV infection.
- Active autoimmune disease, or history of autoimmune disease likely to recur. Systemic corticosteroid therapy equivalent to >10 mg/day prednisone (or other immunosuppressive therapies) within 14 days before first dose.
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- Prior therapy with any antibody or agent targeting T-cell co-regulatory proteins (e.g., PD-1, PD-L1, CTLA-4, TIM-3, LAG-3).
- Interstitial lung disease (ILD), or history of ILD requiring steroid therapy. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (e.g., bronchiolitis obliterans), or evidence of active pneumonia on screening chest CT.
- Live vaccine administration within 28 days prior to first study drug dose. Any condition or comorbidity contraindicating chemo- or radiotherapy (e.g., active infection, myocardial infarction within 6 months, symptomatic heart disease including unstable angina, congestive heart failure, uncontrolled arrhythmia, ongoing immunosuppressive therapy).
- Pregnant or breastfeeding women; women of childbearing potential or men unwilling to use adequate contraception.
- Known hereditary bleeding diathesis or coagulation disorder.
- Prior malignancy, except adequately treated non-melanoma skin cancer, or in situ carcinoma (e.g., breast, oral, cervical) with expected survival >3 years.
- Any other medical, psychiatric, or laboratory abnormality that, in the investigator's judgment, could interfere with trial participation or interpretation of results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai
Xuwei Cai, 86021-22200000, zengya1225@126.com
About this study
Official title: A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy：A Phase II Trial
The study is being conducted to evaluation of the Efficacy and Safety of QL1706 Combined with Chemotherapy Induction in Sequential Immunotherapy Consolidation After Concurrent Chemoradiotherapy for Limited-Stage Small Cell Lung Cancer(LS-SCLC), and Exploration of the Correlation Between Biomarkers (PD-L1, TMB, ctDNA, etc.) Related to QL1706 Treatment and Treatment Efficacy and Prognosis.
QL1706 (Iparomlimab and Tuvonralimab) is a single bifunctional MabPair product against PD-1 and CTLA-4. QL1604 is a monoclonal antibody against PD-1.
- Conditions
- Limited-stage Small Cell Lung Cancer (LS-SCLC), Chemoradiotherapy, Induction Therapy, Consolidation Immunotherapy
- Being tested
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
- Keywords
- Limited-stage small cell lung cancer, QL1706, chemoradiotherapy, induction therapy, consolidation immunotherapy
- 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.
QL1706 (bispecific antibody targeting PD-1 and CLTA-4)Drug
Induction: QL1706 5 mg/kg IV on Day 1, Etoposide: 100 mg/m² IV on Days 1-3, Cisplatin or Carboplatin: Cisplatin 75 mg/m² IV on Day 1 or Cisplatin 25 mg/m² IV on Days 1-3, Or Carboplatin AUC = 5 IV on Day 1, Q3W, for a total of 2 cycles.
Chemoradiotherapy：Thoracic Radiotherapy（60 Gy in 30 fractions, once daily (2 Gy/fraction), or 45 Gy in 30 fractions, twice daily (1.5 Gy/fraction)），Etoposide 100 mg/m² IV on Days 1-3, Cisplatin either 75 mg/m² IV on Day 1, or 25 mg/m² IV on Days 1-3, Or Carboplatin AUC=5 IV on Day 1 PCI: Patients achieving or approaching complete response, per investigator assessment, 25Gy in 10 fractions.
Consolidation: QL1706 5 mg/kg IV on Day 1, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Induction: QL1706 combined with Etoposide and platinum, intravenous infusion (IV), every 3 weeks.
Chemoradiotherapy, followed by QL1706 consolidation, intravenous infusion (IV), every 3 weeks. Receives: Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
To evaluate the efficacy of QL1706 combined with chemotherapy as induction therapy followed by chemoradiotherapy (CRT) for patients with LS-SCLC as measured by investigator-assessed PFS
Measured: up to 12 months after the last participant entry
Secondary outcomes (7)
Overall Survival (OS)
To evaluate the efficacy of QL1706 combined with chemotherapy as induction therapy followed by chemoradiotherapy (CRT) for patients with LS-SCLC as measured by investigator-assessed OS
Measured: up to 12 months after the last participant entry
Objective Response Rate (ORR)
Assessed according to RECIST V1.1.The Objective Response Rate (ORR) is defined as the best ORR during the study period, including cases of Complete Response (CR) and Partial Response (PR)
Measured: through study completion, an average of 12 months after last patient entry
Duration of Response (DoR)
For patients who achieve Complete Response (CR) or Partial Response (PR), the time from the first tumor assessment showing response to disease progression or death (whichever occurs first).
Measured: time from the first tumor assessment showing response to disease progression or death (whichever occurs first),assessed up to 24 months
Disease Control Rate (DCR)
DCR refers to the percentage of cases with the best efficacy evaluation of "Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)
Measured: through study completion, an average of 12 months
Quality-of-life(QoL)
QoL scores will be transformed to a scale of 0-100 according to the EORTC QLQ scoring manual. Mean scores will be compared at each assessment timepoint, and a difference of 10 points is considered clinically relevant.
Measured: Through study completion, an average of 12 months after last participant entry
Correlation between outcomes of study treatment and biomarkers in tissue, blood
A detailed plan for analyses will be defined when sufficient material for translational research has been collected.
Measured: Through study completion, an average of 2 years after last patient entry
Adverse events(AE)
Number of participant with treatment-related adverse events assessed based on CTCAE v5.0
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start23 Oct 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited-stage Small Cell Lung Cancer (LS-SCLC)Studies of the same condition, open and under way.
- More trials run by Shanghai Chest 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuwei Cai, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091305
- Sponsor's protocol ID
- IS25129
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy：A Phase II Trial
- ClinicalTrials.gov ID
- NCT07091305
- Acronym / sponsor ID
- IS25129
- Conditions
- Limited-stage Small Cell Lung Cancer (LS-SCLC), Chemoradiotherapy, Induction Therapy, Consolidation Immunotherapy
- Keywords
- Limited-stage small cell lung cancer, QL1706, chemoradiotherapy, induction therapy, consolidation immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 29 Jul 2025 (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.
The study is being conducted to evaluation of the Efficacy and Safety of QL1706 Combined with Chemotherapy Induction in Sequential Immunotherapy Consolidation After Concurrent Chemoradiotherapy for Limited-Stage Small Cell Lung Cancer(LS-SCLC), and Exploration of the Correlation Between Biomarkers (PD-L1, TMB, ctDNA, etc.) Related to QL1706 Treatment and Treatment Efficacy and Prognosis.
QL1706 (Iparomlimab and Tuvonralimab) is a single bifunctional MabPair product against PD-1 and CTLA-4. QL1604 is a monoclonal antibody against PD-1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4)Induction: QL1706 combined with Etoposide and platinum, intravenous infusion (IV), every 3 weeks. Chemoradiotherapy, followed by QL1706 consolidation, intravenous infusion (IV), every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient must be aged between 18 and 75 years (inclusive of boundary values), and both males and females are eligible.
- Pathologically confirmed LS-SCLC
- Investigator confirmation of at least one measurable lesion, as defined by RECIST v1.1
- ECOG performance status of 0 or 1
- Forced expiratory volume in one second (FEV₁) > 1.0 L
Key exclusion criteria (13 listed)
- Known hypersensitivity to QL1706 or any of its excipients
- Histologically confirmed non-small cell lung cancer (NSCLC) or mixed tumor containing an NSCLC component.
- History of another primary malignancy or previous allogeneic organ transplantation.
- Surgery (other than diagnostic biopsy) within 4 weeks before first dose of study drug.
- Active substance abuse (e.g., illicit drug use), chronic alcoholism, AIDS, or known HIV infection.
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 |
|---|---|---|
| QL1706 (bispecific antibody targeting PD-1 and CLTA-4)Induction: QL1706 5 mg/kg IV on Day 1, Etoposide: 100 mg/m² IV on Days 1-3, Cisplatin or Carboplatin: Cisplatin 75 mg/m² IV on Day 1 or Cisplatin 25 mg/m² IV on Days 1-3, Or Carboplatin AUC = 5 IV on Day 1, Q3W, for a total of 2 cycles. Chemoradiotherapy：Thoracic Radiotherapy（60 Gy in 30 fractions, once daily (2 Gy/fraction), or 45 Gy in 30 fractions, twice daily (1.5 Gy/fraction)），Etoposide 100 mg/m² IV on Days 1-3, Cisplatin either 75 mg/m² IV on Day 1, or 25 mg/m² IV on Days 1-3, Or Carboplatin AUC=5 IV on Day 1 PCI: Patients achieving or approaching complete response, per investigator assessment, 25Gy in 10 fractions. Consolidation: QL1706 5 mg/kg IV on Day 1, Q3W | Drug | Experimental arm |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 12 months after the last participant entry
To evaluate the efficacy of QL1706 combined with chemotherapy as induction therapy followed by chemoradiotherapy (CRT) for patients with LS-SCLC as measured by investigator-assessed PFS
7 secondary outcomes
Overall Survival (OS)
Time frame: up to 12 months after the last participant entry
Objective Response Rate (ORR)
Time frame: through study completion, an average of 12 months after last patient entry
Duration of Response (DoR)
Time frame: time from the first tumor assessment showing response to disease progression or death (whichever occurs first),assessed up to 24 months
Disease Control Rate (DCR)
Time frame: through study completion, an average of 12 months
Quality-of-life(QoL)
Time frame: Through study completion, an average of 12 months after last participant entry
Correlation between outcomes of study treatment and biomarkers in tissue, blood
Time frame: Through study completion, an average of 2 years after last patient entry
Adverse events(AE)
Time frame: through study completion, an average of 12 months
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 11 Jun 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.
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 QL1706 (bispecific antibody targeting PD-1 and CLTA-4) in people with Limited-stage Small Cell Lung Cancer (LS-SCLC) and Chemoradiotherapy, run by Shanghai Chest Hospital 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 11 Jun 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?
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 Xuwei Cai (02122200000, birdhome2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up to 12 months after the last participant entry). 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 11 Jun 2026.