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

Qilu Pharmaceutical

Status and phase: Active, not recruiting; Phase 2

Conditions: Non-small-cell Lung Cancer

Treatments: Drug: QL1706

Study type: Interventional

Funder types: Industry

Identifiers

NCT05329025

QL1706-201

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Treatment A

Experimental group

Description:

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:

Drug: QL1706

Treatment B

Experimental group

Description:

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.

Treatment:

Drug: QL1706