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

June 4, 2026 updated by: Li Zhang, MD, Sun Yat-sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. Absolute neutrophil count ≥ 1,500/mcL
    2. Platelet count > 90,000/mcL
    3. Hemoglobin ≥ 9 g/dL (allowing for Hgb transfusion)
    4. Creatinine ≤ 1.5 × ULN
    5. Total bilirubin ≤ 1.5 mg/dL or ≤ 26 μmol/L
    6. If there is liver metastasis, AST (SGOT) / ALT (SGPT) ≤ 5 × ULN; if there is no liver metastasis, ≤ 2.5 × ULN

    7. 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):

    1. No hysterectomy or bilateral oophorectomy;

    2. No natural menopause for at least 12 consecutive months (i.e., any time during the previous 12 months there was menstruation).

      Exclusion Criteria:

  • 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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cohort 1
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
Every 3 weeks, 5mg/kg of QL1706 is administered intravenously until the disease progresses.
Drug: Anlotinib
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.
Active Comparator: cohort 2
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
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.
Experimental: cohort 3
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
Every 3 weeks, 5mg/kg of QL1706 is administered intravenously until the disease progresses.
Drug: Anlotinib
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.
Active Comparator: cohort 4
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From date of first study treatment to date of death from any cause, assessed up to approximately 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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).
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
Disease Control Rate (DCR), the proportion of patients achieving the best overall therapeutic response of CR, PR or SD
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
The 12-month overall survival rate is defined as the proportion of patients who remain alive 12 months after the first trial treatment.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Li Zhang, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SL-B2025-731-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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