Extensive-stage Small Cell Lung CancerPhase 3NCT07802821
A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
A Phase 3 study testing QLC5508, QL2107 and Tislelizumab in people with Extensive-stage Small Cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in participants with extensive-stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- QLC5508, QL2107 and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2026to 15 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Participants with histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the Veterans Administration Lung Cancer Study Group (VALG) staging system.
- No prior systemic treatment for ES-SCLC.
- At least one extracranial measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, without deterioration within 2 weeks prior to the first dose of study treatment.
- Life expectancy ≥12 weeks.
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- Has adequate organ function.
- Male and female participants of reproductive/childbearing potential must agree to avoid pregnancy.
- Voluntarily sign the written informed consent form and comply with the protocol requirements.
Who cannot join
- Has received or undergoing any of the following treatment:
- Previous or current treatment with B7-H3 targeted therapy. Previous or current treatment with topoisomerase I inhibitors.
- Participants with transformed Non-Small Cell Lung Cancer (NSCLC), epidermal growth factor receptor (EGFR) mutation-positive NSCLC that has transformed to SCLC, or mixed SCLC-NSCLC histology.
- Presence with active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression.
- Radiotherapy with a limited field of radiation within 2 weeks prior to the study treatment; more than 30% of the bone marrow irradiation or large-scale radiotherapy within 4 weeks prior to study treatment.
- Major surgery within 4 weeks prior to the study treatment.
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- Unresolved AEs ≥ Grade 2 (CTCAE v6.0) from prior therapy.
- Previous or concurrent primary malignancies.
- History of severe heart disease or cerebrovascular disease.
- History of Severe or uncontrolled hypertension or diabetes mellitus.
- Severe infection within 4 weeks prior to study treatment; or uncontrolled active infection at screening.
- Known or suspected interstitial lung disease/non-infectious pneumonitis; or other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity.
- Known history of pre-existing or newly diagnosed autoimmune disease.
- History of severe neuropathy or mental disorders.
- History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to study drugs or any components of the study drugs.
- Unlikely to comply with study procedures and requirements in the opinion of the investigator.
- Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
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 East Hospital
Shanghai, 200000
Caicun Zhou, PhD, +86-21-38804518, dfec_filings@163.com
About this study
Official title: A Phase III, Randomized, Controlled, Open-label Clinical Study to Compare the Efficacy and Safety of QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy as First-line Treatment in Participants With Extensive-stage Small Cell Lung Cancer
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in participants with extensive-stage small cell lung cancer.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- QLC5508, QL2107, Tislelizumab, Carboplatin, Cisplatin
- 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.
QLC5508Drug
QLC5508 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first.
QL2107Drug
QL2107 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for QL2107 will be 2 years.
TislelizumabDrug
Tislelizumab will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for Tislelizumab will be 2 years.
CarboplatinDrug
Carboplatin will be administered intravenously once every 3 weeks. Carboplatin treatment will be administered for up to 4 cycles.
CisplatinDrug
Cisplatin will be administered intravenously once every 3 weeks. Cisplatin treatment will be administered for up to 4 cycles.
EtoposideDrug
Etoposide will be administered intravenously once every 3 weeks. Etoposide treatment will be administered for up to 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| QLC5508 in combination with QL2107 | Experimental | Not described Receives: Drug: QLC5508; Drug: QL2107 |
| Tislelizumab in Combination with Platinum-based Chemotherapy | Active comparator | Not described Receives: Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS is defined as the duration from the date of randomization to the date of death due to any cause.
Measured: Up to approximately 36 months
Secondary outcomes (9)
Progression-free survival (PFS)
PFS is defined as the duration from the date of randomization to the date of first documented progressive disease (PD) based on investigator assessment, or death from any cause, whichever occurs first.
Measured: Up to approximately 36 months
Objective response rate (ORR)
ORR is defined as the percentage of participants achieved complete response or partial response as assessed according to RECIST v1.1 criteria.
Measured: Up to approximately 36 months
Duration of response (DOR)
DOR is defined as the duration from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
Measured: Up to approximately 36 months
Disease control rate (DCR)
DCR is defined as the percentage of participants achieved complete response, partial response, or stable disease as assessed according to RECIST v1.1 criteria.
Measured: Up to approximately 36 months
6-month PFS rate
The 6-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 6 months from the date of randomization.
Measured: Up to approximately 36 months
12-month PFS rate
The 12-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 12 months from the date of randomization.
Measured: Up to approximately 36 months
12-month OS rate
The 12-month OS rate is defined as the proportion of participants who are alive at 12 months from the date of randomization.
Measured: Up to approximately 36 months
24-month OS rate
The 24-month OS rate is defined as the proportion of participants who are alive at 24 months from the date of randomization.
Measured: Up to approximately 36 months
Treatment Emergent Adverse Event (TEAE)
TEAEs are defined as any adverse event (AE) that occurs after the initiation of study treatment, or any pre-existing condition that worsens in severity or frequency after the initiation of study treatment, regardless of the causal relationship to the study treatment.
TEAEs will be graded and summarized by type, frequency, and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start27 Oct 2026
- Primary completion15 Mar 2029 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage 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
- None (open label)
- Enrolment
- 556 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
- NCT07802821
- Sponsor's protocol ID
- QLC5508-304
- Status last verified
- Oct 2026
- First submitted
- 30 Aug 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Controlled, Open-label Clinical Study to Compare the Efficacy and Safety of QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy as First-line Treatment in Participants With Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07802821
- Acronym / sponsor ID
- QLC5508-304
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2026 (actual)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 3 Sep 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 trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in participants with extensive-stage small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLC5508 in combination with QL2107 | Experimental | Drug: QLC5508, Drug: QL2107 |
| Tislelizumab in Combination with Platinum-based Chemotherapy | Active comparator | Drug: Tislelizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: Etoposide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years.
- Participants with histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the Veterans Administration Lung Cancer Study Group (VALG) staging system.
- No prior systemic treatment for ES-SCLC.
- At least one extracranial measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, without deterioration within 2 weeks prior to the first dose of study treatment.
Key exclusion criteria (17 listed)
- Has received or undergoing any of the following treatment:
- Previous or current treatment with B7-H3 targeted therapy. Previous or current treatment with topoisomerase I inhibitors.
- Participants with transformed Non-Small Cell Lung Cancer (NSCLC), epidermal growth factor receptor (EGFR) mutation-positive NSCLC that has transformed to SCLC, or mixed SCLC-NSCLC histology.
- Presence with active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression.
- Radiotherapy with a limited field of radiation within 2 weeks prior to the study treatment; more than 30% of the bone marrow irradiation or large-scale radiotherapy within 4 weeks prior to study treatment.
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 |
|---|---|---|
| QLC5508QLC5508 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first. | Drug | QLC5508 in combination with QL2107 |
| QL2107QL2107 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for QL2107 will be 2 years. | Drug | QLC5508 in combination with QL2107 |
| TislelizumabTislelizumab will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for Tislelizumab will be 2 years. | Drug | Tislelizumab in Combination with Platinum-based Chemotherapy |
| CarboplatinCarboplatin will be administered intravenously once every 3 weeks. Carboplatin treatment will be administered for up to 4 cycles. | Drug | Tislelizumab in Combination with Platinum-based Chemotherapy |
| CisplatinCisplatin will be administered intravenously once every 3 weeks. Cisplatin treatment will be administered for up to 4 cycles. | Drug | Tislelizumab in Combination with Platinum-based Chemotherapy |
| EtoposideEtoposide will be administered intravenously once every 3 weeks. Etoposide treatment will be administered for up to 4 cycles. | Drug | Tislelizumab in Combination with Platinum-based Chemotherapy |
Primary outcome
Overall survival (OS)
Time frame: Up to approximately 36 months
OS is defined as the duration from the date of randomization to the date of death due to any cause.
9 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to approximately 36 months
Objective response rate (ORR)
Time frame: Up to approximately 36 months
Duration of response (DOR)
Time frame: Up to approximately 36 months
Disease control rate (DCR)
Time frame: Up to approximately 36 months
6-month PFS rate
Time frame: Up to approximately 36 months
12-month PFS rate
Time frame: Up to approximately 36 months
12-month OS rate
Time frame: Up to approximately 36 months
24-month OS rate
Time frame: Up to approximately 36 months
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 36 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 30 Oct 2026.
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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 3 study testing QLC5508, QL2107 and Tislelizumab in people with Extensive-stage Small Cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd. 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 17 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 30 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 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 Haiying Yu, Bachelor (+86-17821799566, haiying.yu@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to approximately 36 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 30 Oct 2026.