NSCLC
Conditions
Keywords
iparomlimab and tuvonralimab, QL1706, Checkpoint inhibitor, NSCLC
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).
Interventions
DRUGQL1706 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
Sponsors
Guangdong Association of Clinical Trials
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 years | From the first treatment to the date of first documentation of disease progression, or death due to any cause |
| Overall survival | 2 years | From the first administration to death from any cause |
Outcome results
None listed