Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of NSCLC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Qilu Pharmaceutical Co. Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Oct 2025 → ongoing

Decision date (initial)

2025-08-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Qilu Pharmaceutical Co., Ltd.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

Pharmacokinetic (PK): To demonstrate PK similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda®

Secondary objectives 3

1. PK: To evaluate the maximum (peak) serum concentrations after the initial dose and at steady state as well as serum trough concentrations of QL2107 compared with Keytruda®
2. Immunogenicity Objective: To evaluate and compare the immunogenicity profiles of QL2107 and Keytruda®
3. Safety Objectives: To evaluate and compare the safety profiles of QL2107 and Keytruda®

Conditions and MedDRA coding

Non-small cell lung cancer

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

IPD plan description

The plan to share Individual Participant Data (IPD) is currently pending, as it requires further ethical approvals and consent from investigators and patients.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Subjects who voluntarily participate; have read, understood and signed the informed consent form; and are able to comply with the study procedures.
2. Adult subjects (male or female) ≥ 18 years of age on the day of signing the informed consent form.
3. Disease status: Subjects with completely resected, histologically- or cytologically-confirmed (Stage II or IIIA) NSCLC, as per the American Joint Committee on Cancer Eighth Edition. Complete resection (R0) is achieved when resection margins are free, systematic or lobe-specific nodal dissection has been performed, the highest lymph node station harvested is negative, and there is no extracapsular nodal involvement.
4. Patients will be eligible to participate regardless of the level of PD-L1 status. Patients should provide PD-L1 reports or provide archived or fresh tissue samples for PD-L1 tests which may be performed locally or in central laboratory. A tumor tissue sample obtained at surgical rection is preferred; tumor samples obtained before NSCLC surgery are allowed only if the most recent biopsy/tumor sample cannot be collected.
5. 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 subject is randomized.
6. 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.
7. Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion criteria 5

1. Surgical-related AEs or chemotherapy-related toxicity not resolved to Grade 1, with the exception of Grade ≤2 alopecia, fatigue, neuropathy, and lack of appetite/nausea.
2. Subjects who have received systemic corticosteroids (>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. Note: Inhaled or topical steroids and adrenal replacement steroids are permitted in the absence of an active autoimmune disorder.
3. Subjects with known epidermal growth factor receptor (EGFR)-sensitive mutations or anaplastic lymphoma kinase (ALK) gene translocations are not allowed. Subjects must provide EGFR and ALK reports from previous histological or cytological tests; if no prior EGFR or ALK test has been performed, archived tissue samples should be provided for EGFR and ALK tests which may be performed.
4. Received prior therapy with an anticytotoxic T-lymphocyte antigen-4 monoclonal antibody (eg, ipilimumab), anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent; or agent directed to another stimulatory or co-inhibitory T cell receptor.
5. Prior or planned neoadjuvant or adjuvant radiotherapy and/or neoadjuvant chemotherapy for the current malignancy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Area under the concentration time curve for 1 dosing interval (tau = 21 days) after a single (initial) dose (AUC tau,sd) of QL2107 and Keytruda® (Cycle 1)
2. Area under the concentration time curve for 1 dosing interval (tau = 21 days) at steady state (AUC tau,ss) of QL2107 and Keytruda® (Cycle 7)

Secondary endpoints 3

1. Maximum (peak) serum concentration after a single dose (C max,sd) of QL2107 and Keytruda® (initial dose at Cycle 1).
2. Maximum (peak) serum concentration at steady state (C max,ss) of QL2107 and Keytruda® (Cycle 7).
3. The trough serum concentration measured before the next dose is administered (C trough) of QL2107 and Keytruda® (predose samples) at Cycle 2 (Week 4), Cycle 4 (Week 10), Cycle 5 (Week 13), Cycle 6 (Week 16), Cycle 7 (Week 19), Cycle 10 (Week 28) and Cycle 14 (Week 40).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Qilu Pharmaceutical Co. Ltd.

Sponsor organisation

Qilu Pharmaceutical Co. Ltd.

Address

8888 Lvyou Road, High Tech Zone High Tech Zone

City

Jinan

Postcode

250104

Country

China

Scientific contact point

Organisation

Qilu Pharmaceutical Co. Ltd.

Contact name

Chunmei Li

Public contact point

Organisation

Qilu Pharmaceutical Co. Ltd.

Contact name

Chunmei Li

Third parties 7

Locations

5 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 71 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications