臨床研究等提出・公開システム

A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer

Phase 3 Study of Chemotherapy with MK-7684A or Atezolizumab in First-Line ES-SCLC

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Complete

June. 17, 2022

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

-Has histologically or cytologically confirmed diagnosis of 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

-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
-Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
-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

Both

ES-SCLC

Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W (every 3 weeks) on Day 1 of each cycle until discontinuation criteria are met.
Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.
Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)
Etoposide 100 mg/m2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles
Cisplatin 75 mg/m2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Overall Survival (OS)

-Progression-Free Survival (PFS)
-Objective Response Rate (ORR)
-Duration of Response (DOR)
-Percentage of Participants Who Experienced an Adverse Event (AE)
-Percentage of Participants Who Discontinued Study Treatment Due to an AE
-Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
-Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
-Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
-Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
-Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
-Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
-TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
-TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
-TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
-TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

+81-22-222-6181

April. 20, 2022

Yes

https://engagezone.msd.com/

USA/Canada/Austria/Finland/France/Germany/Italy/Portugal/the Netherlands/Spain/Sweden/Switzerland/U.K./Lithuania/Ireland/Israel/Russia/Turkey/Ukraine/Greece/Hungary/Poland/Romania/Australia/New Zealand/Algiers near/Brazil/Mexico/Korea/China