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

Not Applicable

Not yet recruiting

• Conditions: NSCLC
• Interventions: Drug: QL1706 plus bevacizumab with or without chemotherapy

• Registration Number: NCT07134413
• Lead Sponsor: Guangdong Association of Clinical Trials

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Primary Completion: 2027-10
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 77

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)

7. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QL1706 plus bevacizumab combined chemotherapy	QL1706 plus bevacizumab with or without chemotherapy	Patients will receive QL1706 (5 mg/kg) plus bevacizumab (15 mg/kg) and chemotherapy (nab-paclitaxel, pemetrexed, or docetaxel) every 3 weeks.
QL1706 combined bevacizumab	QL1706 plus bevacizumab with or without chemotherapy	Patients will receive QL1706 (5 mg/kg) plus bevacizumab (15 mg/kg) every 3 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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