QL1706 and Bevacizumab for PD-L1-negative Non-Squamous NSCLC
QL1706 plus bevacizumab with or without chemotherapy
Treatment Study
Summary
Study start date: August 1, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on finding out how well a new combination of treatments works for patients with a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC). These patients have previously been treated with drugs called immune checkpoint inhibitors but have not responded to them. The study aims to see if using QL1706 together with another drug called bevacizumab, with or without additional chemotherapy, can help these patients. This is especially important for those whose cancer has advanced and are PD-L1 negative, meaning they do not have a specific protein on their cancer cells that can be targeted by existing treatments. Participants in the study will be divided into two groups. One group will receive QL1706 and bevacizumab along with a chemotherapy drug that they haven't been treated with before. The other group will receive only QL1706 and bevacizumab. The chemotherapy drugs available are nab-paclitaxel, pemetrexed, or docetaxel. The study will monitor the effectiveness and safety of these treatments in helping control the lung cancer. Researchers will look for any changes in the cancer and any side effects experienced by the patients to determine how well the treatments work and how safe they are.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.77 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives