pembrolizumab for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Has previously untreated resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC), confirmed by pathology or imaging\n- Able to undergo protocol therapy, including necessary surgery\n- Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy\n- Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.\n- Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis."}

Exclusion criteria

• {"criterion_text":"- Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.\n- Has Grade ≥2 peripheral neuropathy\n- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.\n- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.\n- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n- Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n- Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.\n- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.\n- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n- Active infection requiring systemic therapy.\n- Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) [qualitative]) infection.\n- Known history of human immunodeficiency virus (HIV) infection\n- History of allogeneic tissue/solid organ transplant"}

Primary endpoints

• {"endpoint_text":"- Pathological Complete Response (pCR)\n- Percent Residual Viable Tumor (%RVT)","definition_or_measurement_approach":"Pathological Complete Response (pCR): incidence in the resected primary tumor and lymph nodes assessed by BIPR (blinded independent pathology review). Percent Residual Viable Tumor (%RVT): extent of residual viable tumor in resected lung tumor/lymph node sections relative to total carcinoma area assessed by BIPR."}

Secondary endpoints

• {"endpoint_text":"- Percentage of Participants Who Report at Least 1 Adverse Event (AE)\n- Percentage of Participants Who Discontinue Study Treatment Due to an AE\n- Event-free Survival (EFS)\n- Overall Survival (OS)\n- Distant Metastasis-Free Survival (DMFS)\n- Objective Response Rate (ORR)\n- Percentage of Participants Who Experience a Perioperative Complication\n- Mean Length of Length of Hospital Stay\n- Percentage of Participants Who Require Hospital Readmission after Discharge\n- Mean Length of Surgery\n- Percentage of Participants Who Require a Blood Transfusion","definition_or_measurement_approach":"EFS: estimated by either biopsy assessed by a local pathologist or by imaging assessed by the investigator using RECIST 1.1. ORR: assessed by the investigator according to RECIST 1.1. OS and DMFS are standard survival endpoints (overall survival; distant metastasis-free survival). Other safety and perioperative endpoints are reported as percentages or means as described but no additional measurement definitions provided in the available data."}

Spain

Earliest CTIS Part Ii Submission Date

30-05-2025

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

299

Number Of Sites

1

Number Of Participants

7

Poland

Earliest CTIS Part Ii Submission Date

30-08-2024

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

574

Number Of Sites

3

Number Of Participants

11

Hungary

Earliest CTIS Part Ii Submission Date

30-08-2024

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

572

Number Of Sites

3

Number Of Participants

9

Greece

Earliest CTIS Part Ii Submission Date

14-05-2025

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

317

Number Of Sites

4

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

28-08-2024

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

576

Number Of Sites

3

Number Of Participants

10

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

central imaging

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Name

Almac Clinical Technologies LLC

Responsibilities

code:3

Name

PPD Global Central Labs

Responsibilities

central laboratory services (code:4)

Third parties

• {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"central imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Bioanalytical Laboratory","duties_or_roles":"code:4","organisation_type":"Health care"}