Authorised Therapeutic confirmatory (Phase III) Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS ≥50%

Clinical Trial to compare subcutaneous pembrolizumab given with hyaluronidase to intravenous pembrolizumab in patients with newly diagnosed stage IV (non-small cell) lung cancer who are PD-L1 Strong

EU CTIS ID: 2024-513165-39-00

What this study is testing

1.To evaluate MK-3475A SC to pembrolizumab IV with respect to AUC 2.To evaluate MK-3475A SC to pembrolizumab IV with respect to steady state Ctrough

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer(NSCLC).
  • Measurable disease as assessed by the local site investigator/radiology.

You likely can't join if

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  • Received prior systemic anticancer therapy for their metastatic NSCLC.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active CNS metastases and/or carcinomatous meningitis.
  • Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
See the full eligibility criteria
Who can join
  • Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer(NSCLC).
  • Measurable disease as assessed by the local site investigator/radiology.
What rules you out
  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  • Received prior systemic anticancer therapy for their metastatic NSCLC.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active CNS metastases and/or carcinomatous meningitis.
  • Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Active infection requiring systemic therapy.

The study team makes the final eligibility decision.

Where it's taking place

  • Korea, Republic of
  • United States
  • United Kingdom
  • Guatemala
  • Turkey
  • Japan
  • Peru
  • China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Korea, Republic of; United States; United Kingdom; Guatemala; Turkey; Japan and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.