Intismeran Autogene: 1 mg Intramuscular (IM) Injection
Pembrolizumab: 200 mg IV Infusion
Carboplatin: Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion
Paclitaxel: 200 or 175 mg/m\^2 IV Infusion
Nab-paclitaxel: 100 mg/m\^2 IV Infusion
Placebo: Placebo matched to Intismeran Autogene IM injection
Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer.
The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.
| Facility | City | Region | Status |
|---|---|---|---|
| Moffitt Cancer Center ( Site 0021) | Tampa | Florida | Recruiting |
| VA Ann Arbor Healthcare System ( Site 0019) | Ann Arbor | Michigan | Recruiting |
| Washington University School of Medicine ( Site 0024) | St Louis | Missouri | Recruiting |
| Valley Health Systems - Ridgewood Campus ( Site 0010) | Paramus | New Jersey | Recruiting |
| New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001) | Albany | New York | Recruiting |
| Cleveland Clinic - Ohio ( Site 0016) | Cleveland | Ohio | Recruiting |
| Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025) | Corvallis | Oregon | Recruiting |
| Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000) | Nashville | Tennessee | Recruiting |
| Texas Oncology - Central/South Texas ( Site 8002) | Austin | Texas | Recruiting |
| Virginia Cancer Specialists ( Site 0003) | Fairfax | Virginia | Recruiting |
| Swedish Medical Center-Swedish Cancer Institute ( Site 0023) | Seattle | Washington | Recruiting |
| Hospital Italiano de Buenos Aires ( Site 0200) | Ciudad Autonoma de Buenos Aires. | Buenos Aires | Recruiting |
| Instituto Alexander Fleming ( Site 0201) | Ciudad Autonoma de Buenos Aires | Buenos Aires | Recruiting |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205) | Mar del Plata | Buenos Aires | Recruiting |
| Clinica Adventista Belgrano ( Site 0206) | Caba. | Buenos Aires F.D. | Recruiting |
| Fundacion Estudios Clinicos ( Site 0207) | Rosario | Santa Fe Province | Recruiting |
| Sanatorio Parque ( Site 0203) | Rosario | Santa Fe Province | Recruiting |
| Westmead Hospital ( Site 0400) | Westmead | New South Wales | Recruiting |
| Princess Alexandra Hospital ( Site 0403) | Woolloongabba | Queensland | Recruiting |
| One Clinical Research ( Site 0402) | Nedlands | Western Australia | Recruiting |
| Centro de Estudios Clínicos SAGA ( Site 0307) | Santiago | Region M. de Santiago | Recruiting |
| FALP ( Site 0300) | Santiago | Region M. de Santiago | Recruiting |
| Bradfordhill ( Site 0301) | Santiago | Region M. de Santiago | Recruiting |
| Bradford Hill Norte ( Site 0308) | Antofagasta | Chile | Recruiting |
| Centre Georges François Leclerc ( Site 0805) | Dijon | Cote-d Or | Recruiting |
| Institut de Cancérologie de l'Ouest ( Site 0801) | Angers | Pays de la Loire Region | Recruiting |
| CHU GABRIEL MONTPIED ( Site 0802) | Clermont-Ferrand | Puy-de-Dome | Recruiting |
| Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004) | Ravenna | Emilia-Romagna | Recruiting |
| Ospedale San Raffaele-Oncologia Medica ( Site 1002) | Milan | Italy | Recruiting |
| Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000) | Milan | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001) | Roma | Italy | Recruiting |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101) | Poznan | Greater Poland Voivodeship | Recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100) | Warsaw | Masovian Voivodeship | Recruiting |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102) | Przemyśl | Podkarpackie Voivodeship | Recruiting |
| National Cancer Center ( Site 0504) | Goyang-si | Kyonggi-do | Recruiting |
| Seoul National University Bundang Hospital ( Site 0500) | Seongnam-si | Kyonggi-do | Recruiting |
| Chungbuk National University Hospital-Internal medicine ( Site 0501) | Cheongju-si | North Chungcheong | Recruiting |
| Asan Medical Center ( Site 0503) | Seoul | South Korea | Recruiting |
| Samsung Medical Center ( Site 0502) | Seoul | South Korea | Recruiting |
| ICO L Hospitalet ( Site 1311) | Hospitalet | Barcelona | Recruiting |
+ 15 more sites — see the full list on the official registry below.
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 NCT07221474 on ClinicalTrials.gov ↗ ← All trials in the USA