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Clinical Trials in China / NCT05224141
Active, not recruiting Phase 3

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)

NCT05224141 · tracked via the Priya Life Science China tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2022-03-24
Last updated
2025-07-08

Condition(s) studied

Small Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

Pembrolizumab/Vibostolimab Co-FormulationSaline placeboEtoposideCisplatinAtezolizumabCarboplatin

Pembrolizumab/Vibostolimab Co-Formulation: Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Saline placebo: Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)

Etoposide: Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles

Cisplatin: Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Atezolizumab: Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Carboplatin: Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Study summary

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy * Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan * Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse * Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse * Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 * Has a predicted life expectancy of \>3 months Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease * Has received prior treatment for Small Cell Lung Cancer (SCLC) * Is expected to require any other form of antineoplastic therapy for SCLC while on study * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has a known history of, or active, neurologic paraneoplastic syndrome * Has an active infection requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV) infection * Has a known history of Hepatitis B or known active Hepatitis C virus infection * Has had an allogenic tissue/solid organ transplant * Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention * Has symptomatic ascites or pleural effusion

Primary outcome measure(s)

Trial sites (140)

FacilityCityRegionStatus
Infirmary Cancer Care ( Site 0022) Mobile Alabama
Los Angeles Hematology Oncology Medical Group ( Site 0006) Los Angeles California
VA West Los Angeles Medical Center ( Site 0004) Los Angeles California
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) Boca Raton Florida
Fort Wayne Medical Oncology and Hematology ( Site 0013) Fort Wayne Indiana
Dana-Farber Cancer Institute ( Site 0018) Boston Massachusetts
Cancer and Hematology Centers of Western Michigan ( Site 0001) Grand Rapids Michigan
Hattiesburg Clinic Hematology/Oncology ( Site 0003) Hattiesburg Mississippi
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005) Lancaster Pennsylvania
Blue Ridge Cancer Care ( Site 0015) Blacksburg Virginia
University of Virginia Cancer Center ( Site 0019) Charlottesville Virginia
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203) Ciudad Autonoma de Buenos Aires Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) Mar del Plata Buenos Aires
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200) Buenos Aires Buenos Aires F.D.
Hospital Provincial del Centenario ( Site 0205) Rosario Santa Fe Province
Sanatorio Parque ( Site 0202) Rosario Santa Fe Province
Nepean Hospital ( Site 2700) Kingswood New South Wales
Calvary Mater Newcastle ( Site 2703) Waratah New South Wales
Frankston Hospital-Oncology and Haematology ( Site 2702) Frankston Victoria
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701) Melbourne Victoria
Medizinische Universität Graz ( Site 0504) Graz Styria
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505) Linz Upper Austria
Kepler Universitätsklinikum ( Site 0507) Linz Upper Austria
Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0502) Vienna Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501) Vienna Austria
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106) Kingston Ontario
Lakeridge Health ( Site 0102) Oshawa Ontario
Anhui Cancer Hospital ( Site 2915) Hefei Anhui
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901) Beijing Beijing Municipality
Beijing Peking Union Medical College Hospital ( Site 2921) Beijing Beijing Municipality
Fujian Provincial Cancer Hospital-oncology department ( Site 2904) Fuzhou Fujian
Harbin Medical University Cancer Hospital-oncology of department ( Site 2920) Harbin Heilongjiang
Henan Cancer Hospital ( Site 2916) Zhengzhou Henan
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912) Wuhan Hubei
Hubei Cancer Hospital ( Site 2922) Wuhan Hubei
Hunan Cancer Hospital ( Site 2907) Changsha Hunan
The First Affiliated Hospital of Soochow University ( Site 2913) Suzhou Jiangsu
Jilin Cancer Hospital-GCP office ( Site 2909) Changchun Jilin
The First Hospital of Jilin University ( Site 2914) Changchun Jilin
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910) Xi'an Shaanxi

+ 100 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile →

More Merck Sharp & Dohme LLC trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05224141 on ClinicalTrials.gov ↗ ← All trials in China