A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Recruiting · NCT07190248 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 10 US states.
- Central Alabama Research ( Site 0108) - Birmingham, Alabama, United States
- University of Connecticut Health Center ( Site 0130) - Farmington, Connecticut, United States
- Stamford Hospital ( Site 0126) - Stamford, Connecticut, United States
- Mount Sinai Cancer Center ( Site 0137) - Miami Beach, Florida, United States
- Indiana University Health Arnett Cancer Center ( Site 0116) - Lafayette, Indiana, United States
- New England Cancer Specialists ( Site 0139) - Westbrook, Maine, United States
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0152) - Hackensack, New Jersey, United States
- New York Oncology Hematology, P.C. ( Site 0119) - Albany, New York, United States
- Wilmot Cancer Institute ( Site 0141) - Rochester, New York, United States
- St. Charles Health System, Inc ( Site 0146) - Bend, Oregon, United States
- Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111) - Lancaster, Pennsylvania, United States
- Blue Ridge Cancer Care ( Site 0144) - Roanoke, Virginia, United States
- Gazi Universitesi Tip Fakultesi ( Site 2404) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Sehir Hastanesi ( Site 2401) - Ankara, Turkey (Türkiye)
- Yitzhak Shamir Medical Center. ( Site 1709) - Beer Ya Akov, Israel
- Queen Elizabeth Hospital Birmingham ( Site 2612) - Birmingham, United Kingdom
- SC ONCO CARD SRL ( Site 2109) - Brasov, Romania
- SC MNT Healthcare Europe SRL ( Site 2105) - Bucharest, Romania
- Delta Health Care SRL ( Site 2108) - Bucharest, Romania
- AOU Renato Dulbecco ( Site 1804) - Catanzaro, Italy
- Chiba University Hospital ( Site 2812) - Chiba, Japan
- Scientia Investigacion Clinica S.C. ( Site 0804) - Chihuahua City, Mexico
- Hospital Italiano de Cordoba ( Site 0308) - Córdoba, Argentina
- CEMAIC ( Site 0309) - Córdoba, Argentina
- Trakya Universitesi Tip Fakultesi ( Site 2406) - Edirne, Turkey (Türkiye)
- National Hospital Organization Kyushu Medical Center ( Site 2801) - Fukuoka, Japan
- University Medical Center Groningen ( Site 1908) - Groningen, Netherlands
- MEDI-K ( Site 3803) - Guatemala City, Guatemala
- Centro Integral De Oncologia Gastrointestinal Y Hemato-Oncologia De Guatemala, S. A ( Site 3802) - Guatemala City, Guatemala
- Servicios Médicos Oncológicos ( Site 3804) - Guatemala City, Guatemala
- Hiroshima City Hiroshima Citizens Hospital ( Site 2821) - Hiroshima, Japan
- Bakirkoy Dr. Sadi Konuk Training and Research Hospital ( Site 2408) - Istanbul, Turkey (Türkiye)
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2403) - Istanbul, Turkey (Türkiye)
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2405) - Istanbul, Turkey (Türkiye)
- Shaare Zedek Medical Center ( Site 1706) - Jerusalem, Israel
- Meir Medical Center. ( Site 1702) - Kfar Saba, Israel
- Cengild G.I. Medical Centre ( Site 3112) - Kuala Lumpur, Malaysia
- Saiseikai Kumamoto Hospital ( Site 2816) - Kumamoto, Japan
- Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512) - Kyiv, Ukraine
- Universal Clinic Oberig ( Site 2506) - Kyiv, Ukraine
- Leicester Royal Infirmary ( Site 2610) - Leicester, United Kingdom
- IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0902) - Lima, Peru
- Oncosalud ( Site 0901) - Lima, Peru
- Clinical Chc Montlégia ( Site 3901) - Liège, Belgium
- Hospital Universitario Ramon y Cajal ( Site 2203) - Madrid, Spain
- Instituto Nacional de Cancerologia. ( Site 0808) - Mexico City, Mexico
- Grupo Médico ASSET ( Site 0811) - Mexico City, Mexico
- ASST Grande Ospedale Metropolitano Niguarda ( Site 1817) - Milan, Italy
- A.O.R.N. Antonio Cardarelli ( Site 1810) - Naples, Italy
- Taipei Medical University Shuang Ho Hospital ( Site 3602) - New Taipei City, Taiwan
- Osaka Metropolitan University Hospital ( Site 2826) - Osaka, Japan
- Groupe Hospitalier Paris Saint Joseph ( Site 1215) - Paris, France
- Hôpital Européen Georges Pompidou ( Site 1214) - Paris, France
- Policlinico San Matteo ( Site 1802) - Pavia, Italy
- Sheba Medical Center ( Site 1700) - Ramat Gan, Israel
- Kyung Hee University Medical Center ( Site 3500) - Seoul, South Korea
- Korea University Guro Hospital ( Site 3505) - Seoul, South Korea
- Hospital Universitario Virgen de Valme ( Site 2205) - Seville, Spain
- IBCC - Núcleo de Pesquisa e Ensino ( Site 0417) - São Paulo, Brazil
- National Cheng Kung University Hospital ( Site 3604) - Tainan, Taiwan
Showing 60 of 205 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →