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Not yet recruiting NCT07162883

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

Phase III Interventional Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QL2107, Keytruda®.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of QL2107 (Keytruda® Biosimilar Candidate) in Comparison With Keytruda® (Pembrolizumab) for Adjuvant Therapy to Demonstrate Pharmacokinetic Similarity in Subjects With Resected Non-Small Cell Lung Cancer

Overview

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.

Interventions

  • Drug QL2107
    IV infusion.
  • Drug Keytruda®
    IV infusion.

Primary outcome measures

  • AUCtau,sd of QL2107 and Keytruda [Time frame: At Cycle 1 (cycle length = 21 days)]]
  • AUCtau,ss of QL2107 and Keytruda [Time frame: At Cycle 7 (cycle length = 21 days)]]
Secondary outcome measures (5)
  • Cmax,sd of QL2107 and Keytruda [Time frame: At Cycle 1 (cycle length = 21 days)]]
  • Cmax,ss of QL2107 and Keytruda [Time frame: At Cycle 7 (cycle length = 21 days)]]
  • Ctrough of QL2107 and Keytruda [Time frame: Up to Cycle 10 at Predose (cycle length = 21 days)]
  • Number of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) [Time frame: Up to Week 52]
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to Week 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07162883 · QL2107-102 · 2024-519883-42-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗