Small Cell Lung CancerPhase 2/3NCT07636226
QL1706 Plus Anlotinib as a Later-line Treatment for Patients With Advanced Lung Cancer
A Phase 2/3 study testing QL1706 and Anlotinib in people with Small Cell Lung Cancer, run by Sun Yat-sen University.
Trial summary
This is a multicenter, open-label, randomized controlled phase II/III study evaluating the efficacy and safety of QL1706 in combination with anlotinib as later-line treatment in patients with advanced lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- QL1706 and Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 30 Dec 2029
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female patients aged 18 years and above, up to 80 years old. 2. Small cell lung cancer or lung squamous cell carcinoma confirmed by tissue or pathological examination.
- 3. Requires previous treatment with platinum-based drugs. 4. Requires previous treatment with PD-1/PD-L1 drugs. 5. Patients must have received at least 2 lines of treatment, no more than 3 lines of treatment.
- 6. Confirmed as small cell lung cancer by histological examination. 7. Able to provide informed consent and comply with the trial protocol. 8. According to RECIST 1.1 standards, there are measurable lesions (CT scan). 9. Expected lifespan ≥ 12 weeks. 10. ECOG performance status 0-1. 11. Patients must have adequate organ and bone marrow functions, defined as follows:
- Absolute neutrophil count ≥ 1,500/mcL
- Platelet count > 90,000/mcL
- Hemoglobin ≥ 9 g/dL (allowing for Hgb transfusion)
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- Creatinine ≤ 1.5 × ULN
- Total bilirubin ≤ 1.5 mg/dL or ≤ 26 μmol/L
- If there is liver metastasis, AST (SGOT) / ALT (SGPT) ≤ 5 × ULN; if there is no liver metastasis, ≤ 2.5 × ULN
- Albumin ≥ 2.5 g/dL 12. Patients are allowed to receive palliative radiotherapy (such as radiotherapy after brain metastasis), provided that there are measurable target lesions in the radiation field of the patient.
- 13. Able to go to the research center to ensure that patients complete all research-related appointments.
- 14. Pregnant women and male partners of pregnant women must agree to take adequate contraceptive measures (hormonal or barrier methods; abstinence) before entering the study, during the study, and within 90 days after completing the study (hormonal or barrier methods; abstinence). If a woman becomes pregnant during the study or suspects she is pregnant, she should immediately inform the attending doctor.
- Note: Pregnant women are defined as any woman meeting the following criteria (regardless of sexual orientation, whether tubal ligation has been performed or being single):
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- No hysterectomy or bilateral oophorectomy;
- No natural menopause for at least 12 consecutive months (i.e., any time during the previous 12 months there was menstruation).
Who cannot join
- 1. Patients with symptomatic central nervous system metastases, or those with unstable neurological symptoms requiring an increase in the dosage of corticosteroids.
- 2. Presence of another primary malignant tumor (excluding cervical carcinoma in situ or skin basal cell carcinoma).
- 3. The patient has a clinically significant disease that affects their participation in this study, including but not limited to: active or uncontrolled infection, SARS-CoV-2 infection, immunodeficiency, hepatitis B, hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled arrhythmia, QTc interval prolongation > 450 ms or a mental illness/socioeconomic condition that limits their compliance with the study requirements.
- 4. Previous use of CTLA-4 monotherapy or combination antibodies containing CTLA-4.
- 5. Previous treatment with anti-angiogenic drugs. 6. Presence of uncontrolled or symptomatic pleural or pericardial effusion, etc.
- 7. Uncontrolled or clinically significant third-space effusion. 8. Severe adverse reactions occurred during previous immunotherapy, and the investigator considers it unsuitable for re-administration of immunotherapy.
- 9. Any condition that may interfere with the subject's participation in the study or the evaluation of the study results.
- 10. Receiving major surgery within 30 days before the first day of the study. 11. Currently using or expected to use within 14 days before the first administration of drugs or foods known to be potent CYP3A4/5 inhibitors or CYP3A4/5 inducers (such as grapefruit juice or grapefruit/grapefruit-related citrus fruits (such as oranges, grapefruits), ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, indinavir, saquanavir, ritonavir, nelfinavir, amprenavir, fosamprenavir, nefazodone, lopinavir, ritonavir), and applying these drugs locally (such as 2% ketoconazole cream is allowed);
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yan Huang, MD contact
About this study
Official title: A Multicenter, Open-label, Randomized Controlled Phase II/III Study Evaluating the Efficacy and Safety of QL1706 in Combination With Anlotinib as a Later-line Treatment for Patients With Advanced Lung Cancer
This is a multicenter, open-label, randomized controlled phase II/III study evaluating the efficacy and safety of QL1706 in combination with anlotinib as later-line treatment in patients with advanced lung cancer.
Read the detailed description
The study consists of four cohorts, each planning to enroll 30 subjects. Cohort 1 (advanced SCLC) and Cohort 3 (advanced squamous NSCLC) will receive later-line treatment with QL1706 5 mg/kg intravenously once every 3 weeks (Q3W) plus anlotinib 10 mg orally once daily (qd). Cohort 2 (advanced SCLC) and Cohort 4 (advanced squamous NSCLC) will receive anlotinib 10 mg orally once daily alone. Treatment continues until disease progression (and the investigator determines that the subject no longer derives clinical benefit) or other criteria for study treatment discontinuation are met, whichever occurs first.
- Conditions
- Small Cell Lung Cancer
- Being tested
- QL1706, Anlotinib
- Keywords
- small cell lung cancer, later-line
- 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.
QL1706Drug
Every 3 weeks, 5mg/kg of QL1706 is administered intravenously until the disease progresses.
AnlotinibDrug
10mg Anlotinib is administered orally. It is given daily for the first 14 days, then stopped for 7 days. A 3-week period constitutes one cycle, and this process continues until the disease progresses.
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Experimental | Cohort 1 includes patients with advanced SCLC who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past. Receives: Drug: QL1706; Drug: Anlotinib |
| cohort 2 | Active comparator | Cohort 2 includes patients with advanced SCLC who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past. Receives: Drug: Anlotinib |
| cohort 3 | Experimental | Cohort 3 includes patients with advanced lung squamous cell carcinoma who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past. Receives: Drug: QL1706; Drug: Anlotinib |
| cohort 4 | Active comparator | Cohort 4 includes patients with advanced lung squamous cell carcinoma who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past. Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival (OS), defined as the time from first study treatment to death from any cause.
Measured: From date of first study treatment to date of death from any cause, assessed up to approximately 36 months
Secondary outcomes (4)
PFS
Progression-free survival (PFS) is defined as the time from the first trial treatment to disease progression or death due to any cause (whichever occurs first).
Measured: From date of first study treatment to the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to approximately 36 months.
DCR
Disease Control Rate (DCR), the proportion of patients achieving the best overall therapeutic response of CR, PR or SD
Measured: From first study treatment to disease progression or initiation of new anti-tumor therapy, assessed up to approximately 36 months
12-months OS rate
The 12-month overall survival rate is defined as the proportion of patients who remain alive 12 months after the first trial treatment.
Measured: From date of first study treatment to date of death from any cause, assessed up to 12 months
Adverse Events
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Relationship to study treatment (QL1706 and/or anlotinib) is assessed by the investigator.
Measured: From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (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 Sun Yat-sen UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, MD, Sun Yat-sen University
- Investigators
- Li Zhang, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636226
- Sponsor's protocol ID
- SL-B2025-731-02
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing was not included in the informed consent form approved by the ethics committee. Therefore, sharing individual participant data would violate the ethical agreements made with study participants.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized Controlled Phase II/III Study Evaluating the Efficacy and Safety of QL1706 in Combination With Anlotinib as a Later-line Treatment for Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT07636226
- Acronym / sponsor ID
- SL-B2025-731-02
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell lung cancer, later-line
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 9 Jun 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 is a multicenter, open-label, randomized controlled phase II/III study evaluating the efficacy and safety of QL1706 in combination with anlotinib as later-line treatment in patients with advanced lung cancer.
Detailed description
The study consists of four cohorts, each planning to enroll 30 subjects. Cohort 1 (advanced SCLC) and Cohort 3 (advanced squamous NSCLC) will receive later-line treatment with QL1706 5 mg/kg intravenously once every 3 weeks (Q3W) plus anlotinib 10 mg orally once daily (qd). Cohort 2 (advanced SCLC) and Cohort 4 (advanced squamous NSCLC) will receive anlotinib 10 mg orally once daily alone. Treatment continues until disease progression (and the investigator determines that the subject no longer derives clinical benefit) or other criteria for study treatment discontinuation are met, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Experimental | Drug: QL1706, Drug: AnlotinibCohort 1 includes patients with advanced SCLC who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past. |
| cohort 2 | Active comparator | Drug: AnlotinibCohort 2 includes patients with advanced SCLC who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past. |
| cohort 3 | Experimental | Drug: QL1706, Drug: AnlotinibCohort 3 includes patients with advanced lung squamous cell carcinoma who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past. |
| cohort 4 | Active comparator | Drug: AnlotinibCohort 4 includes patients with advanced lung squamous cell carcinoma who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Male or female patients aged 18 years and above, up to 80 years old. 2. Small cell lung cancer or lung squamous cell carcinoma confirmed by tissue or pathological examination.
- 3. Requires previous treatment with platinum-based drugs. 4. Requires previous treatment with PD-1/PD-L1 drugs. 5. Patients must have received at least 2 lines of treatment, no more than 3 lines of treatment.
- 6. Confirmed as small cell lung cancer by histological examination. 7. Able to provide informed consent and comply with the trial protocol. 8. According to RECIST 1.1 standards, there are measurable lesions (CT scan). 9. Expected lifespan ≥ 12 weeks. 10. ECOG performance status 0-1. 11. Patients must have adequate organ and bone marrow functions, defined as follows:
- 13. Able to go to the research center to ensure that patients complete all research-related appointments.
- 14. Pregnant women and male partners of pregnant women must agree to take adequate contraceptive measures (hormonal or barrier methods; abstinence) before entering the study, during the study, and within 90 days after completing the study (hormonal or barrier methods; abstinence). If a woman becomes pregnant during the study or suspects she is pregnant, she should immediately inform the attending doctor.
Key exclusion criteria (8 listed)
- 1. Patients with symptomatic central nervous system metastases, or those with unstable neurological symptoms requiring an increase in the dosage of corticosteroids.
- 2. Presence of another primary malignant tumor (excluding cervical carcinoma in situ or skin basal cell carcinoma).
- 3. The patient has a clinically significant disease that affects their participation in this study, including but not limited to: active or uncontrolled infection, SARS-CoV-2 infection, immunodeficiency, hepatitis B, hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled arrhythmia, QTc interval prolongation > 450 ms or a mental illness/socioeconomic condition that limits their compliance with the study requirements.
- 4. Previous use of CTLA-4 monotherapy or combination antibodies containing CTLA-4.
- 5. Previous treatment with anti-angiogenic drugs. 6. Presence of uncontrolled or symptomatic pleural or pericardial effusion, etc.
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 |
|---|---|---|
| QL1706Every 3 weeks, 5mg/kg of QL1706 is administered intravenously until the disease progresses. | Drug | cohort 1, cohort 3 |
| Anlotinib10mg Anlotinib is administered orally. It is given daily for the first 14 days, then stopped for 7 days. A 3-week period constitutes one cycle, and this process continues until the disease progresses. | Drug | cohort 1, cohort 2, cohort 3, cohort 4 |
Primary outcome
OS
Time frame: From date of first study treatment to date of death from any cause, assessed up to approximately 36 months
Overall survival (OS), defined as the time from first study treatment to death from any cause.
4 secondary outcomes
PFS
Time frame: From date of first study treatment to the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to approximately 36 months.
DCR
Time frame: From first study treatment to disease progression or initiation of new anti-tumor therapy, assessed up to approximately 36 months
12-months OS rate
Time frame: From date of first study treatment to date of death from any cause, assessed up to 12 months
Adverse Events
Time frame: From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.
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 9 Jun 2026.
- Individual participant dataSharing planned: No. IPD sharing was not included in the informed consent form approved by the ethics committee. Therefore, sharing individual participant data would violate the ethical agreements made with study participants.
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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.
Yan Huang, MD contact
Li Zhang principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing QL1706 and Anlotinib in people with Small Cell Lung Cancer, run by Sun Yat-sen 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 16 inclusion and 8 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 9 Jun 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 combined 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.
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 Li Zhang, MD (+86-20-87343289, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: From date of first study treatment to date of death from any cause, assessed 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 9 Jun 2026.