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

ConditionNSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Association of Clinical Trials

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

77 Participants
are divided into 2 treatment groups
Group A: QL1706 plus bevacizumab combined chemotherapyExperimental treatment 1 intervention
Group B: QL1706 combined bevacizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate

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.

Time frame
2 years

Secondary outcomes

1

Progression-free survival

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

Time frame
2 years
2

Overall survival

From the first administration to death from any cause

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Association of Clinical Trials

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: