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

NCT07162883 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: QL2107-1022024-519883-42-00
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Lung Neoplasms; Lymphatic Metastasis

Outcome Measures

Primary Outcomes (2)

• AUCtau,sd of QL2107 and Keytruda

  Area under the concentration time curve for 1 dosing interval (tau = 21 days) after a single initial) dose (AUCtau,sd) of QL2107 and Keytruda® will be reported.

  At Cycle 1 (cycle length = 21 days)]

• AUCtau,ss of QL2107 and Keytruda

  Area under the concentration time curve for 1 dosing interval (tau = 21 days) at steady state (AUCtau,ss) of QL2107 and Keytruda® will be reported.

  At Cycle 7 (cycle length = 21 days)]

Secondary Outcomes (5)

• Cmax,sd of QL2107 and Keytruda

  At Cycle 1 (cycle length = 21 days)]

• Cmax,ss of QL2107 and Keytruda

  At Cycle 7 (cycle length = 21 days)]

• Ctrough of QL2107 and Keytruda

  Up to Cycle 10 at Predose (cycle length = 21 days)

• Number of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)

  Up to Week 52

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to Week 52

Study Arms (2)

QL2107 200mg

EXPERIMENTAL

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.

Drug: QL2107

Keytruda® 200 mg

ACTIVE COMPARATOR

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

Drug: Keytruda®

Interventions

QL2107 DRUG

IV infusion.

QL2107 200mg

Keytruda® DRUG

IV infusion.

Keytruda® 200 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Lung Neoplasms; Lymphatic Metastasis

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share