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

Non-small-cell Lung Cancer Clinical Trial

Official title:

A Study of the Safety and Efficacy of QL1706 in Combination With Chemotherapy in First-Line Treatment of Patients With Stage IIIB/C and Stage IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05329025
• Other study ID #: QL1706-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

Drug:
• QL1706
QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Objective Response Rate (ORR) in the ITT population		First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
Secondary	Duration of response (DOR) in the ITT population		First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
Secondary	Overall Survival (OS) in the ITT population		First administration until disease progression or death, which ever occurs first (up to approximately 24 months)