Small-cell Lung CancerPhase 3NCT06789796
a Study of QL1706 or QL1604 in Patients With Limited-stage Small Cell Lung Cancer After Chemoradiotherapy.
A Phase 3 study testing Iparomlimab and Tuvonralimab (QL1706) and QL1604 in people with Small-cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The study is being conducted to evaluate the efficacy and safety of QL1706 versus QL1604 monotherapy as consolidation treatment in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after concurrent or sequential chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- Iparomlimab and Tuvonralimab (QL1706) and QL1604
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 636 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Mar 2030
- Phase
- Phase 3
- 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 [I-III stage SCLC (any T, any N, M0)], according to the American Joint Committee on Cancer (AJCC, 8th edition) staging manual.
- Received 4 cycles of chemotherapy concurrent or sequential with radiotherapy. Chemotherapy must contain platinum and etoposide. Radiotherapy must be either total 60-70 Gy over 6 weeks for the QD regimen or total 45 Gy over 3 weeks for BID schedules.
- Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry.
Who cannot join
- Mixed SCLC and non-small cell lung cancer (NSCLC).
- Extensive-stage SCLC.
- Active or prior documented autoimmune or inflammatory disorders.
- Received other chemotherapy regimens besides etoposide and platinum-based therapy.
- Active or prior documented autoimmune or inflammatory disorders.
- Presence of interstitial lung disease or active non-infectious pneumonia (excluding grade 1 radiation pneumonitis not treated with corticosteroids).
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 Randomized, Double-blind Phase III Clinical Study of QL1706 Versus QL1604 as Consolidation Treatment in Patients With Limited-stage Small Cell Lung Cancer Who Have Not Experienced Disease Progression After Concurrent or Sequential Chemoradiotherapy.
The study is being conducted to evaluate the efficacy and safety of QL1706 versus QL1604 monotherapy as consolidation treatment in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after concurrent or sequential chemoradiotherapy.
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
- Small-cell Lung Cancer
- Being tested
- Iparomlimab and Tuvonralimab (QL1706), placebo for QL1604, QL1604, placebo for Iparomlimab and Tuvonralimab (QL1706)
- 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.
Iparomlimab and Tuvonralimab (QL1706)Drug
5mg/kg , every 3 weeks
placebo for QL1604Drug
every 3 weeks
QL1604Drug
200mg, every 3 weeks
placebo for Iparomlimab and Tuvonralimab (QL1706)Drug
every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| QL1706 group | Experimental | Iparomlimab and Tuvonralimab + placebo for QL1604, intravenous infusion (IV), every 3 weeks Receives: Drug: Iparomlimab and Tuvonralimab (QL1706); Drug: placebo for QL1604 |
| QL1604 group | Active comparator | QL1604 + placebo for Iparomlimab and Tuvonralimab, IV, every 3 weeks Receives: Drug: QL1604; Drug: placebo for Iparomlimab and Tuvonralimab (QL1706) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after chemoradiotherapy (CRT) for patients with LS-SCLC as measured by Blinded Independent Review Committee (BIRC)-assessed PFS
Measured: up to 2 years
Overall survival (OS)
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by OS
Measured: up to 5 years
Secondary outcomes (7)
objective response rate (ORR)
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by ORR
Measured: up to 2 years
disease control rate (DCR)
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by DCR
Measured: up to 2 years
duration of response (DoR)
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by DoR
Measured: up to 2 years
PFS
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by Investigator-assessed PFS
Measured: up to 2 years
1-year OS rate
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by 1-year OS rate
Measured: up to 1 year
2-year OS rate
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by 2-year OS rate
Measured: up to 2 years
adverse events
To compare and evaluate the safety of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by the incidence of adverse events (Percentage of participants with treatment-related adverse events as assessed by CTCAEv5.0.) and abnormal laboratory parameters.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789796
- Sponsor's protocol ID
- QL1706-310
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Phase III Clinical Study of QL1706 Versus QL1604 as Consolidation Treatment in Patients With Limited-stage Small Cell Lung Cancer Who Have Not Experienced Disease Progression After Concurrent or Sequential Chemoradiotherapy.
- ClinicalTrials.gov ID
- NCT06789796
- Acronym / sponsor ID
- QL1706-310
- Conditions
- Small-cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 636 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 23 Jan 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 evaluate the efficacy and safety of QL1706 versus QL1604 monotherapy as consolidation treatment in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after concurrent or sequential chemoradiotherapy.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706 group | Experimental | Drug: Iparomlimab and Tuvonralimab (QL1706), Drug: placebo for QL1604Iparomlimab and Tuvonralimab + placebo for QL1604, intravenous infusion (IV), every 3 weeks |
| QL1604 group | Active comparator | Drug: QL1604, Drug: placebo for Iparomlimab and Tuvonralimab (QL1706)QL1604 + placebo for Iparomlimab and Tuvonralimab, 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 (4 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 [I-III stage SCLC (any T, any N, M0)], according to the American Joint Committee on Cancer (AJCC, 8th edition) staging manual.
- Received 4 cycles of chemotherapy concurrent or sequential with radiotherapy. Chemotherapy must contain platinum and etoposide. Radiotherapy must be either total 60-70 Gy over 6 weeks for the QD regimen or total 45 Gy over 3 weeks for BID schedules.
- Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry.
Key exclusion criteria (6 listed)
- Mixed SCLC and non-small cell lung cancer (NSCLC).
- Extensive-stage SCLC.
- Active or prior documented autoimmune or inflammatory disorders.
- Received other chemotherapy regimens besides etoposide and platinum-based therapy.
- Active or prior documented autoimmune or inflammatory disorders.
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 (QL1706)5mg/kg , every 3 weeks | Drug | QL1706 group |
| placebo for QL1604every 3 weeks | Drug | QL1706 group |
| QL1604200mg, every 3 weeks | Drug | QL1604 group |
| placebo for Iparomlimab and Tuvonralimab (QL1706)every 3 weeks | Drug | QL1604 group |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 2 years
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after chemoradiotherapy (CRT) for patients with LS-SCLC as measured by Blinded Independent Review Committee (BIRC)-assessed PFS
Overall survival (OS)
Time frame: up to 5 years
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by OS
7 secondary outcomes
objective response rate (ORR)
Time frame: up to 2 years
disease control rate (DCR)
Time frame: up to 2 years
duration of response (DoR)
Time frame: up to 2 years
PFS
Time frame: up to 2 years
1-year OS rate
Time frame: up to 1 year
2-year OS rate
Time frame: up to 2 years
adverse events
Time frame: up to 2 years
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 Feb 2025.
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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 3 study testing Iparomlimab and Tuvonralimab (QL1706) and QL1604 in people with Small-cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd..
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 4 inclusion and 6 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 11 Feb 2025. 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 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?
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 Zekai Yu, bachelor's degree (18611428367, zekai.yu@qilu-pharma.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 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?
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 Feb 2025.