Clinical trial · Interventional

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

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

NCT07134413CI-TRIAL-00093960not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
NSCLC	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
QL1706 plus bevacizumab with or without chemotherapy	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
QL1706 plus bevacizumab combined chemotherapy
description
Patients will receive QL1706 (5 mg/kg) plus bevacizumab (15 mg/kg) and chemotherapy (nab-paclitaxel, pemetrexed, or docetaxel) every 3 weeks.
interventionNames
1. Drug: QL1706 plus bevacizumab with or without chemotherapy
type
EXPERIMENTAL
label
QL1706 combined bevacizumab
description
Patients will receive QL1706 (5 mg/kg) plus bevacizumab (15 mg/kg) every 3 weeks.
interventionNames
1. Drug: QL1706 plus bevacizumab with or without chemotherapy

Primary outcomes (1)

measure
Overall Response Rate
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.