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

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).

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed an informed consent form
Patients aged ≥18
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
at least one measurable lesion according to RECIST 1.1 criteria
ECOG PS 0-1.
Subjects must have adequately documented disease progression following prior treatment with PD-1/PD-L1 inhibitors (administered as monotherapy or in combination with chemotherapy)

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

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).
Patients with symptomatic, neurologically unstable central nervous system (CNS) metastases, or CNS diseases that require increased steroid doses to control
Prior lines of systemic anti-tumor therapy ≥ 2.

Treatment and study plan

QL1706 plus bevacizumab with or without chemotherapy

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

Primary outcomes

Overall Response Rate

Time frame: 2 years

ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.

Secondary outcomes

Progression-free survival

Time frame: 2 years

From the first treatment to the date of first documentation of disease progression, or death due to any cause
Overall survival

Time frame: 2 years

From the first administration to death from any cause

Sponsors and collaborators

Lead sponsor

Guangdong Association of Clinical Trials

Other

Registry information

Official study title

Efficacy and Safety of QL1706 and Bevacizumab With or Without Chemotherapy in Patients With Non-Squamous Non-Small Cell Lung Cancer Previously Treated With Immune Checkpoint Inhibitors

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2029
First posted: Aug 21, 2025
Registry last updated: Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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