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Clinical Trial of MK-7684A with chemotherapy for extensive stage small cell lung cancer (ES-SCLC)
EU CTIS ID: 2023-503517-30-00
What this study is testing
To compare overall survival for MK-7684A in combination with etoposide/platinum followed by MK-7684A to atezolizumab in combination with etoposide/platinum followed by atezolizumab.
- 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
- 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
You likely can't join if
- Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
- 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
See the full eligibility criteria
- 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 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Argentina
- Russian Federation
- China
- United States
- Israel
- Turkey
- United Kingdom
- Australia
- Korea, Republic of
- Mexico
- Japan
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 Canada; Argentina; Russian Federation; China; United States; Israel and 6 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.