A Study of QL1706 Combined With Chemotherapy in Advanced Non-small Cell Lung Cancer

Phase 2

Active, not recruiting

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: QL1706

• Registration Number: NCT05329025
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

This study will evaluate the efficacy and safety of QL1706 when given in combination with bevacizumab, paclitaxel or pemetrexed, and carboplatin in patients with Stage IIIB/C and Stage IV Non-Small Cell Lung Cancer (NSCLC). The study will be conducted in two phases: Induction Phase and Maintenance Phase.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Study Start: 2022-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Histologically or cytologically confirmed Stage IIIB/C or IV non-squamous NSCLC Measurable disease, as defined by RECIST v1.1 Eastern Cooperative Oncology Group Performance Status of 0 or 1 Life expectancy >=3 months Adequate hematologic and organ function

Exclusion Criteria

• History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment A	QL1706	Participants with squamous cell carcinoma will receive QL1706, paclitaxel and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with QL1706 until unacceptable toxicity or loss of clinical benefit.
Treatment B	QL1706	Participants with non-squamous cell carcinoma will receive QL1706, bevacizumab, pemetrexed, and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with QL1706, bevacizumab and pemetrexed until unacceptable toxicity or loss of clinical benefit.

Primary Outcome Measures

Name	Time	Method
Adverse events Adverse events Adverse events adverse events	Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) in the intent to treat (ITT) population, as determined by the investigator	First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
Objective Response Rate (ORR) in the ITT population	First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
Duration of response (DOR) in the ITT population	First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
Overall Survival (OS) in the ITT population	First administration until disease progression or death, which ever occurs first (up to approximately 24 months)

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China