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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

11 Nov 2024 → ongoing

Decision date (initial)

2024-10-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-513165-39-00

WHO UTN

U1111-1306-1214

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety

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

Secondary objectives 1

1. To evaluate the safety and tolerability of MK-3475A SC and pembrolizumab IV

Conditions and MedDRA coding

Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS ≥50%

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

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

Exclusion criteria 7

1. Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
2. Received prior systemic anticancer therapy for their metastatic NSCLC.
3. Known additional malignancy that is progressing or has required active treatment within the past 3 years.
4. Known active CNS metastases and/or carcinomatous meningitis.
5. Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed.
6. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
7. Active infection requiring systemic therapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
2. Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State

Secondary endpoints 2

1. Number of Participants Who Report ≥1 Adverse Event (AE)
2. Number of Participants Who Discontinue Study Intervention Due to an AE

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Sung Jin Kim

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Sung Jin Kim

Third parties 9

Locations

4 EU/EEA countries · 13 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 33 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