Clinical Study of QL1706 Combined With Chemotherapy in the Treatment of Patients With Advanced Non-small Cell Lung Cancer

Clinical 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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small-cell Lung Cancer
• Intervention / Treatment: Drug: QL1706

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; 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.	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.
Experimental: Treatment B; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: QL1706-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No