QL1706/Bevacizumab ± Chemotherapy in Post-ICI Non-Squamous NSCLC

NCT ID: NCT07134413

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2029-07-31

Brief Summary

The goal of this clinical trial is to evaluate QL1706 plus bevacizumab with or without chemotherapy in patients with PD-L1-negative, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) previously treated with immune checkpoint inhibitors (ICIs). The primary objectives are:

To assess the efficacy and safety of QL1706 combined with bevacizumab (± chemotherapy) in this population.

Eligible patients with PD-L1-negative, locally advanced or metastatic non-squamous NSCLC who progressed after prior PD-1/PD-L1 inhibitor therapy will be assigned to one of two treatment arms at the investigator's discretion:

Arm 1: QL1706 + bevacizumab + chemotherapy (target enrollment: 67 subjects). Single-agent chemotherapy (selected from regimens not previously received) will be administered, with options including nab-paclitaxel, pemetrexed, or docetaxel.

Arm 2: QL1706 + bevacizumab (target enrollment: 10 subjects).

Conditions

NSCLC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QL1706 plus bevacizumab combined chemotherapy

Patients will receive QL1706 (5 mg/kg) plus bevacizumab (15 mg/kg) and chemotherapy (nab-paclitaxel, pemetrexed, or docetaxel) every 3 weeks.

Group Type: EXPERIMENTAL

QL1706 plus bevacizumab with or without chemotherapy

Intervention Type: DRUG

QL1706(iparomlimab and Tuvonralimab) was generated by using MabPair, a new technological platform that enables the production of two antibodies close to their natural forms from a single host cell line and is manufactured as one product. QL1706 contains a mixture of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 that were produced together in a fixed ratio. Each antibody was individually optimized to achieve desirable target coverage and antibody effector functions.

Bevacizumab is a monoclonal antibody medication used to treat various cancers and a specific eye disease. It works by blocking a protein called VEGF, which helps tumors form new blood vessels, thus starving the tumor of nutrients and oxygen.

Chemotherapy (nab-paclitaxel, pemetrexed, or docetaxel) Nab-paclitaxel, also known as nanoparticle albumin-bound paclitaxel, is a chemotherapy drug used to treat certain cancers. It's a form of paclitaxel that's bound to albumin nanoparticles, which improves its solubility and delivery to cance

QL1706 combined bevacizumab

Patients will receive QL1706 (5 mg/kg) plus bevacizumab (15 mg/kg) every 3 weeks.

Group Type: EXPERIMENTAL

QL1706 plus bevacizumab with or without chemotherapy

Intervention Type: DRUG

QL1706(iparomlimab and Tuvonralimab) was generated by using MabPair, a new technological platform that enables the production of two antibodies close to their natural forms from a single host cell line and is manufactured as one product. QL1706 contains a mixture of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 that were produced together in a fixed ratio. Each antibody was individually optimized to achieve desirable target coverage and antibody effector functions.

Bevacizumab is a monoclonal antibody medication used to treat various cancers and a specific eye disease. It works by blocking a protein called VEGF, which helps tumors form new blood vessels, thus starving the tumor of nutrients and oxygen.

Chemotherapy (nab-paclitaxel, pemetrexed, or docetaxel) Nab-paclitaxel, also known as nanoparticle albumin-bound paclitaxel, is a chemotherapy drug used to treat certain cancers. It's a form of paclitaxel that's bound to albumin nanoparticles, which improves its solubility and delivery to cance

Interventions

QL1706 plus bevacizumab with or without chemotherapy

QL1706(iparomlimab and Tuvonralimab) was generated by using MabPair, a new technological platform that enables the production of two antibodies close to their natural forms from a single host cell line and is manufactured as one product. QL1706 contains a mixture of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 that were produced together in a fixed ratio. Each antibody was individually optimized to achieve desirable target coverage and antibody effector functions.

Bevacizumab is a monoclonal antibody medication used to treat various cancers and a specific eye disease. It works by blocking a protein called VEGF, which helps tumors form new blood vessels, thus starving the tumor of nutrients and oxygen.

Chemotherapy (nab-paclitaxel, pemetrexed, or docetaxel) Nab-paclitaxel, also known as nanoparticle albumin-bound paclitaxel, is a chemotherapy drug used to treat certain cancers. It's a form of paclitaxel that's bound to albumin nanoparticles, which improves its solubility and delivery to cance

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed an informed consent form

2. Patients aged ≥18

3. Histologically or cytologically confirmed stage III or IV non-squamous non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) 8th Edition staging system

4. at least one measurable lesion according to RECIST 1.1 criteria

5. ECOG PS 0-1.

6. Subjects must have adequately documented disease progression following prior treatment with PD-1/PD-L1 inhibitors (administered as monotherapy or in combination with chemotherapy)

8. The most recent tumor tissue sample prior to the first dose of the study drug demonstrated PD-L1 TPS <1% 9. appropriate organ function

Exclusion Criteria

1. Known presence of sensitizing mutations in EGFR, EGFR exon 20 insertions, ALK fusions, ROS1 fusions, RET fusions, NTRK fusions, BRAF V600E mutations, MET exon 14 skipping mutations, or HER2 sensitizing mutations (for other genetic alterations, eligibility will be determined by the Biomarker Committee on a case-by-case basis).

2. Patients with symptomatic, neurologically unstable central nervous system (CNS) metastases, or CNS diseases that require increased steroid doses to control

3. Prior lines of systemic anti-tumor therapy ≥ 2.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Association of Clinical Trials

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

QL-NSCLC-QIBA-1002/CTONG2502

Identifier Type: -

Identifier Source: org_study_id