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New cocktail of drugs aims to tackle tough lung cancer

NCT ID NCT04924101

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether adding experimental drugs (MK-4830, boserolimab, or lenvatinib) to the standard combination of pembrolizumab and chemotherapy can improve outcomes for people with extensive-stage small cell lung cancer. Participants receive one of these new combinations as their first treatment. The study measures how many tumors shrink or disappear and how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab, MK-4830, boserolimab, lenvatinib, etoposide, cisplatin, carboplatin
What this could lead to
If successful, this combination could improve response rates and delay cancer progression for people with advanced small cell lung cancer.
What could go wrong
This is an early-phase trial with no formal hypothesis testing, so results may not confirm benefit. Adding multiple drugs also raises the risk of side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

122 people

The number who actually took part.

Started

Jul 2021

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Lenvatinib (7 days); Etoposide, Cisplatin, or Carboplatin (180 days) and Pembrolizumab, MK-4830, or (no contraception measures); refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per protocol unless confirmed to be azoospermic * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman/women of childbearing potential (WOCBP) or is a WOCBP and uses a contraceptive method that is highly effective with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows: Lenvatinib (30 days), Etoposide, Cisplatin, or Carboplatin (180 days), and Pembrolizumab, MK-4830, or Boserolimab (120 days) * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours (urine test) or 72 hours (serum test) before the first dose of study intervention * Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention * Has measurable disease per RECIST 1.1 as assessed by local site investigator/radiology and verified by blinded independent central review (BICR) * Submits an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated where such sample exist * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization * Has adequate organ function within 10 days before the first dose of study intervention * Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg with no changes in antihypertensive medications within 1 week before randomization Exclusion Criteria: * Has had major surgery within 3 weeks before first dose of study interventions * Has a preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula * Has urine protein ≥1 g/24 hours * Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multiple gated acquisition (MUGA) or echocardiogram (ECHO) * Prolongation of QT interval with Fridericia's correction (QTcF) interval to \>480 ms * Has clinically significant cardiovascular disease or major arterial thromboembolic event within 12 months before first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability * Has active hemoptysis within 3 weeks before the first dose of study intervention * Has gastrointestinal malabsorption or any other condition that might affect oral study intervention absorption * Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention * Has any major hemorrhage or venous thromboembolic events within 3 months before the first dose of study intervention. Participants with venous thrombosis diagnosed more than 3 months before the first dose of study intervention must be on stable doses of anticoagulants * Has a history of inflammatory bowel disease * Has a history of a gastrointestinal perforation within 6 months before the first dose of study intervention * Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease * Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor * Has received prior treatment (chemotherapy, radiotherapy, or surgical resection) including investigational agents for SCLC * Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, 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 radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation. A participant that meets this exclusion criterion but is otherwise deemed eligible for the study may be randomized across the specific intervention groups. * Has symptomatic ascites, pleural effusion, or pericardial effusion. A participant who is clinically stable following treatment for these conditions is eligible * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention * 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. Participants with brain metastases may participate only if they satisfy all of the following: a) Completed treatment at least 14 days before the first dose of study intervention b) Have no evidence of new or enlarging brain metastases confirmed by posttreatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and c) Are neurologically stable without the need for steroids for at least 7 days before the first dose of study intervention as per local site assessment. Participants with untreated brain metastases will be allowed if they are asymptomatic, the investigator determines there is no immediate CNS-specific treatment required, there is no significant surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer in number * Has a history of severe hypersensitivity reaction 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 and/or Hepatitis B virus infection or an active Hepatitis C infection * Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Has had an allogenic tissue/solid organ transplant

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Small cell lung cancer

Contacts and locations

Locations

  • Asan Medical Center-Department of Oncology ( Site 1103)

    Seoul, 05505, South Korea

  • Banner MD Anderson Cancer Center ( Site 0102)

    Gilbert, Arizona, 85234, United States

  • Baptist Health Lexington-Research ( Site 0108)

    Lexington, Kentucky, 40503, United States

  • Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 2502)

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Chungbuk National University Hospital ( Site 1107)

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Cleveland Clinic-Taussig Cancer Center ( Site 0116)

    Cleveland, Ohio, 44195, United States

  • GBUZ "SPb CRPCstmc(o)" ( Site 2705)

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Georgia Cancer Specialists ( Site 0106)

    Atlanta, Georgia, 30341, United States

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2003)

    Hamilton, Ontario, L8V 4X2, Canada

  • Hospital Insular de Gran Canaria ( Site 2402)

    Las Palmas de Gran Canaria, Las Palmas, 35001, Spain

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 2401)

    Barcelona, 08035, Spain

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals ( Site 2403)

    L'Hospitalet de Llobregat, Catalonia, 08908, Spain

  • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 2304)

    Milan, 20141, Italy

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2800)

    Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2005)

    Kingston, Ontario, K7L 2V7, Canada

  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2100)

    Vienna, 1210, Austria

  • Klinik Penzing-2. Lungenabteilung ( Site 2101)

    Vienna, State of Vienna, 1140, Austria

  • Krasnoyarsk Regional Oncology Dispensary, Named after Krizhanovsky ( Site 2708)

    Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia

  • MFSMC-HJWCI-Oncology Research ( Site 0128)

    Baltimore, Maryland, 21237, United States

  • Meir Medical Center ( Site 2601)

    Kfar Saba, 4428164, Israel

  • Memorial Sloan Kettering Cancer Center ( Site 0115)

    New York, New York, 10065, United States

  • N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0122)

    Omaha, Nebraska, 68130, United States

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0129)

    Omaha, Nebraska, 68130, United States

  • Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 2806)

    Budapest, Pest County, 1121, Hungary

  • Ospedale San Raffaele-Oncologia Medica ( Site 2303)

    Milan, Lombardy, 20132, Italy

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0130)

    Fort Wayne, Indiana, 46845, United States

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0114)

    Mineola, New York, 11501, United States

  • Rabin Medical Center-Oncology ( Site 2604)

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology ( Site 2600)

    Haifa, 3109601, Israel

  • Samodzielny Publiczny Zespó Grulicy i Chorób Puc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemi

    Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland

  • Samsung Medical Center ( Site 1100)

    Seoul, 06351, South Korea

  • Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 2704)

    Saint Petersburg, 197758, Russia

  • Semmelweis University-Pulmonológiai Klinika ( Site 2802)

    Budapest, 1083, Hungary

  • Seoul National University Bundang Hospital ( Site 1104)

    Seongnam, Kyonggi-do, 13620, South Korea

  • Seoul National University Hospital ( Site 1101)

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1105)

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center ( Site 2602)

    Jerusalem, 9103102, Israel

  • Sheba Medical Center-ONCOLOGY ( Site 2603)

    Ramat Gan, 5262100, Israel

  • St Francis Cancer Center-Research Office ( Site 0117)

    Greenville, South Carolina, 29607, United States

  • St. Marys Hospital Center ( Site 2000)

    Montreal, Quebec, H3T 1M5, Canada

  • The Catholic University Of Korea St. Vincent's Hospital ( Site 1106)

    Suwon, Kyonggi-do, 16247, South Korea

  • Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 2801)

    Törökbálint, Pest County, 2045, Hungary

  • UPMC Hillman Cancer Center ( Site 0127)

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Colorado Anschutz Medical Campus ( Site 0104)

    Aurora, Colorado, 80045, United States

  • Virginia Cancer Institute ( Site 0119)

    Richmond, Virginia, 23229, United States

  • Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 2805)

    Zalaegerszeg, Zala County, 8900, Hungary

  • ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 2300)

    Siena, Tuscany, 53100, Italy

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