Pembrolizumab for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Subjects who voluntarily participate; have read, understood and signed the informed consent form; and are able to comply with the study procedures."}
• {"criterion_text":"- Adult subjects (male or female) ≥ 18 years of age on the day of signing the informed consent form."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Eastern Cooperative Oncology Group performance status of 0 or 1."}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Prior or planned neoadjuvant or adjuvant radiotherapy and/or neoadjuvant chemotherapy for the current malignancy."}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"PK exposure measure: AUC over one dosing interval (tau = 21 days) after a single initial dose; measured in Cycle 1 samples for QL2107 and Keytruda®."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"PK exposure measure: AUC over one dosing interval (tau = 21 days) at steady state; measured at Cycle 7 for QL2107 and Keytruda®."}

Secondary endpoints

• {"endpoint_text":"- Maximum (peak) serum concentration after a single dose (C max,sd) of QL2107 and Keytruda® (initial dose at Cycle 1).","definition_or_measurement_approach":"Peak serum concentration following the initial (single) dose; measured in Cycle 1."}
• {"endpoint_text":"- Maximum (peak) serum concentration at steady state (C max,ss) of QL2107 and Keytruda® (Cycle 7).","definition_or_measurement_approach":"Peak serum concentration at steady state; measured in Cycle 7."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Predose (trough) serum concentrations measured at specified cycles/weeks (Cycle 2 Week 4; Cycle 4 Week 10; Cycle 5 Week 13; Cycle 6 Week 16; Cycle 7 Week 19; Cycle 10 Week 28; Cycle 14 Week 40)."}

Methods

• Site-based recruitment using localized recruitment materials (patient brochures, patient-facing posters with tear-off leaflets, patient brochure PDFs, clinical trial listing documents). Materials available per-country (EN, PL, ES, GR, RO, HU) as listed in the recruitment documents.
• Investigator/physician outreach using 'Doctor to patient' and 'Doctor to doctor' letters (K2 recruitment materials) to inform referring clinicians and potential participants.
• Flowchart and clinical trial listing materials for participants and sites to explain study pathway.
• Patient travel & reimbursement support coordinated by third parties (e.g. Taxi Travel Ticket S.L., Illingworth Research Group Limited) to assist participant attendance.

Poland

Earliest CTIS Part Ii Submission Date

08-08-2025

Latest Decision Or Authorization Date

29-08-2025

Processing Time Days

21

Number Of Sites

2

Number Of Participants

8

Spain

Earliest CTIS Part Ii Submission Date

11-08-2025

Latest Decision Or Authorization Date

28-08-2025

Processing Time Days

17

Number Of Sites

9

Number Of Participants

19

Hungary

Earliest CTIS Part Ii Submission Date

13-08-2025

Latest Decision Or Authorization Date

01-09-2025

Processing Time Days

19

Number Of Sites

2

Number Of Participants

8

Greece

Earliest CTIS Part Ii Submission Date

22-05-2025

Latest Decision Or Authorization Date

26-08-2025

Processing Time Days

96

Number Of Sites

2

Number Of Participants

9

Romania

Earliest CTIS Part Ii Submission Date

12-08-2025

Latest Decision Or Authorization Date

01-09-2025

Processing Time Days

20

Number Of Sites

4

Number Of Participants

8

Primary sponsor

Full Name

Qilu Pharmaceutical Co. Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

China

Contract research organisations

Name

WCG Clinical Inc.

Responsibilities

sponsorDuties codes: 8

Name

Syneos Health Netherlands B.V.

Responsibilities

sponsorDuties codes: 1,10,11,12,13,2,5,6,8,9

Name

Illingworth Research Group Limited

Responsibilities

Patient travel & reimbursement

Name

Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.

Responsibilities

sponsorDuties code: 4

Name

Catalent Germany Schorndorf GmbH

Responsibilities

sponsorDuties code: 14

Third parties

• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"Patient travel & reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Patient travel & reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,2,5,6,8,9 (multiple operational and study support functions)","organisation_type":"Pharmaceutical company"}