NCT07190248Recruiting
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Summary
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
Inclusion criteria
The main inclusion criteria include but are not limited to the following: • Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c • If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)
Exclusion criteria
The main exclusion criteria include but are not limited to the following: • Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea) • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease • Has a gastrointestinal disorder affecting absorption • Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease • Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC • Has 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 active autoimmune disease that has required systemic treatment in the past 2 years • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease • Has active infection requiring systemic therapy except those specified by protocol • Has history of stem cell/solid organ transplant • Has not adequately recovered from major surgery or has ongoing surgical complications
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Greece, Guatemala, Hungary, Israel, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Romania, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
- Sponsor
- Merck Sharp & Dohme LLC(Industry)
- Protocol no.
- 1084-007
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Drug, Biological
Treatments studied
- Calderasib
- Pembrolizumab (+) Berahyaluronidase alfa
- Pemetrexed
- Cisplatin
- Carboplatin
Locations · 217
- Zurich, SwitzerlandKlinik fur Hamatologie und Onkologie Hirslanden Zurich ( Site 4001)Recruiting at this site
- Zurich, SwitzerlandStadtspital Zürich Triemli - Klinik für Medizinische Onkologie und Hämatologie ( Site 4000)Recruiting at this site
- Marseille, FranceHopital Europeen Marseille ( Site 1207)Recruiting at this site
- Caen, FranceCHU Caen ( Site 1212)Recruiting at this site
- Vandœuvre-lès-Nancy, FranceCentre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1209)Recruiting at this site
- Pau, FranceCentre Hospitalier de Pau ( Site 1217)Recruiting at this site
- Chambéry, FranceCentre Hospitalier Metropole Savoie Site de Chambery ( Site 1208)Recruiting at this site
- Amiens, FranceClinique de l'Europe ( Site 1213)Recruiting at this site
- Paris, FranceGroupe Hospitalier Paris Saint Joseph ( Site 1215)Recruiting at this site
- Paris, FranceHôpital Européen Georges Pompidou ( Site 1214)Recruiting at this site
- Bolzano, ItalyAzienda Santiaria dell'Alto Adige, comprensorio di Bolzano ( Site 1818)Recruiting at this site
- Modena, ItalyAzienda Ospedaliero Universitaria di Modena Policlinico ( Site 1815)Recruiting at this site
- Meldola, ItalyIRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)Recruiting at this site
- Udine, ItalyP.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale ( Site 1813)Recruiting at this site
- Rome, ItalyAzienda Ospedaliera S. Giovanni Addolorata ( Site 1805)Recruiting at this site
- Bergamo, ItalyAzienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1811)Recruiting at this site
- Rozzano, ItalyIstituto Clinico Humanitas ( Site 1812)Recruiting at this site
- Statte, ItalyOspedale San Giuseppe Moscati ( Site 1816)Recruiting at this site
- Florence, ItalyAOU Careggi ( Site 1801)Recruiting at this site
- Catanzaro, ItalyAOU Renato Dulbecco ( Site 1804)Recruiting at this site
- Milan, ItalyASST Grande Ospedale Metropolitano Niguarda ( Site 1817)Recruiting at this site
- Naples, ItalyA.O.R.N. Antonio Cardarelli ( Site 1810)Recruiting at this site
- Pavia, ItalyPoliclinico San Matteo ( Site 1802)Recruiting at this site
- Verona, ItalyAzienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 1809)Recruiting at this site
- Klagenfurt, AustriaKlinikum Klagenfurt am Wörthersee ( Site 1002)Recruiting at this site
- Graz, AustriaMedizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)Recruiting at this site
- Vienna, AustriaKlinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001)Recruiting at this site
- Birmingham, United StatesCentral Alabama Research ( Site 0108)Recruiting at this site
- Farmington, United StatesUniversity of Connecticut Health Center ( Site 0130)Recruiting at this site
- Stamford, United StatesStamford Hospital ( Site 0126)Recruiting at this site
In total, worldwide, 217 of the 221 sites listed in the registry are recruiting; the other 4 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 26, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 187 more locations
Other identifiers
- U1111-1307-9569 · other registry
- 2024-514500-14-00 · other registry
- MK-1084-007 · other identifier
- KANDLELIT-007 · other identifier
- jRCT2031240722 · other registry
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.