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

Official 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

Overview

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

• Drug 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 me

Primary outcome measures

• Overall Response Rate [Time frame: 2 years]

Secondary outcome measures (2)

• Progression-free survival [Time frame: 2 years]
• Overall survival [Time frame: 2 years]

Eligibility criteria

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)

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

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07134413 · QL-NSCLC-QIBA-1002/CTONG2502

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗