Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC)

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: QL2107; Drug: Keytruda®

Study type: Interventional

Funder types: Industry

Identifiers

NCT07162883

QL2107-102

2024-519883-42-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The primary purpose of this study is to demonstrate Pharmacokinetic similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda.

Enrollment: 122 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants (male or female) more than and equal to 18 years of age on the day of signing the ICF.
• Disease status: Participants with completely resected, histologically- or cytologically-confirmed (Stage II or IIIA) NSCLC
• Treatment with platinum-based chemotherapy; • Chemotherapy must have begun within 12 weeks after the resection surgery. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized.
• No evidence of disease (NSCLC) for the post-surgery baseline assessment must be documented by full chest/abdomen/pelvis computed tomography (CT) and/or magnetic resonance imaging (MRI) and brain CT/MRI within 12 weeks prior to the randomization date.
• Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion criteria

• Surgical-related adverse events (AEs) or chemotherapy-related toxicity not resolved to Grade 1, with the exception of Grade <=2 alopecia, fatigue, neuropathy, and lack of appetite/nausea.
• Participants who have received systemic corticosteroids (more than [>] 10 mg prednisone daily or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, or tumor necrosis factor alpha inhibitors) within 2 weeks prior to the first dose.
• Participants with known epidermal growth factor receptor (EGFR)-sensitive mutations or anaplastic lymphoma kinase (ALK) gene translocations are not allowed.
• Received prior therapy with an anticytotoxic T-lymphocyte antigen-4 mAb (example, ipilimumab); anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (Programmed Death-Ligand 1), or anti-programmed cell death ligand 2 (PD-L2) agent; or agent directed to another stimulatory or co-inhibitory T cell receptor.
• Participants with any active autoimmune disease or history of autoimmune diseases including but not limited to autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups

QL2107 200mg

Experimental group

Description:

Participants will receive QL2107 200 milligrams (mg) intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21 days treatment cycle for up to 17 treatment cycles.

Treatment:

Drug: QL2107

Keytruda® 200 mg

Active Comparator group

Description:

Participants will receive Keytruda® 200 mg IV infusion Q3W, on Day 1 of each 21- days treatment cycle for up to 17 treatment cycles.

Treatment:

Drug: Keytruda®