QL1706 Plus Anlotinib as a Later-line Treatment for Patients With Advanced Lung Cancer

NCT07636226 | Not Yet Recruiting Phase 2

• 1 other identifier: SL-B2025-731-02
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; later-line

Outcome Measures

Primary Outcomes (1)

• OS

  Overall survival (OS), defined as the time from first study treatment to death from any cause.

  From date of first study treatment to date of death from any cause, assessed up to approximately 36 months

Secondary Outcomes (4)

• PFS

  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

  From first study treatment to disease progression or initiation of new anti-tumor therapy, assessed up to approximately 36 months

• 12-months OS rate

  From date of first study treatment to date of death from any cause, assessed up to 12 months

• Adverse Events

  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.

Study Arms (4)

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.

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.

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.

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.

Drug: Anlotinib

Interventions

QL1706 DRUG

Every 3 weeks, 5mg/kg of QL1706 is administered intravenously until the disease progresses.

cohort 1; cohort 3

Anlotinib DRUG

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.

cohort 1; cohort 2; cohort 3; cohort 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. 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)
• 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.
• \. Able to go to the research center to ensure that patients complete all research-related appointments.
• \. 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;

You may not qualify if:

• \. Patients with symptomatic central nervous system metastases, or those with unstable neurological symptoms requiring an increase in the dosage of corticosteroids.
• \. Presence of another primary malignant tumor (excluding cervical carcinoma in situ or skin basal cell carcinoma).
• \. 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.
• \. Previous use of CTLA-4 monotherapy or combination antibodies containing CTLA-4.
• \. Previous treatment with anti-angiogenic drugs. 6. Presence of uncontrolled or symptomatic pleural or pericardial effusion, etc.
• \. 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.
• \. Any condition that may interfere with the subject's participation in the study or the evaluation of the study results.
• \. 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);

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li Zhang

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, MD

CONTACT

+86-20-87343289; zhangli@sysucc.org.cn

Yan Huang, MD

CONTACT

huangyan@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share