A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
Recruiting · NCT07554339 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy. The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.
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 a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.
- Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.
- Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.
- Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.
- If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy.
- If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
- Has a body weight ≥35 kg.
Exclusion criteria
- The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.
- Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has received prior treatment (other than definitive CCRT) for NSCLC.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids.
- Has an active infection requiring systemic therapy.
- Has a 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 3 US states.
- NHO Revive Research Institute LLC ( Site 0118) - Lincoln, Nebraska, United States
- New York Oncology Hematology P.C ( Site 9000) - Albany, New York, United States
- WakeMed Raleigh Campus ( Site 0144) - Raleigh, North Carolina, United States
- Hacettepe Universite Hastaneleri ( Site 1900) - Ankara, Turkey (Türkiye)
- Liv Hospital Ankara ( Site 1911) - Ankara, Turkey (Türkiye)
- University Medical Center Groningen ( Site 1505) - Groningen, Netherlands
- Erciyes University ( Site 1904) - Kayseri, Turkey (Türkiye)
- Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005) - Kyiv, Ukraine
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803) - Madrid, Spain
- Hospital Clinico San Carlos ( Site 1810) - Madrid, Spain
- Hospital Universitario La Paz ( Site 1808) - Madrid, Spain
- Taipei Medical University Shuang Ho Hospital ( Site 2612) - New Taipei City, Taiwan
- Severance Hospital, Yonsei University Health System ( Site 2501) - Seoul, South Korea
- Asan Medical Center ( Site 2500) - Seoul, South Korea
- Hospital Universitario Virgen Macarena ( Site 1805) - Seville, Spain
- National Cheng Kung University Hospital ( Site 2601) - Tainan, Taiwan
- Mackay Memorial Hospital ( Site 2611) - Taipei, Taiwan
- National Taiwan University Cancer Center (NTUCC) ( Site 2610) - Taipei, Taiwan
- Tri-Service General Hospital ( Site 2608) - Taipei, Taiwan
- Anhui Provincial Cancer Hospital ( Site 2209) - Hefei, Anhui, China
- ALEXANDRA General Hospital of Athens ( Site 1200) - Athens, Attica, Greece
- Athens Medical Center ( Site 1201) - Athens, Attica, Greece
- Metaxa Cancer Hospital of Piraeus ( Site 1203) - Piraeus, Attica, Greece
- Beijing Peking Union Medical College Hospital ( Site 2220) - Beijing, Beijing Municipality, China
- Clinica Adventista Belgrano ( Site 0304) - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Instituto Alexander Fleming ( Site 0301) - Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303) - Mar del Plata, Buenos Aires, Argentina
- Hospital Britanico de Buenos Aires ( Site 0305) - Buenos Aires, Buenos Aires F.D., Argentina
- Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002) - Chernivtsi, Chernivetska Oblast, Ukraine
- Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012) - Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
- University General Hospital of Alexandroupoli ( Site 1206) - Alexandroupoli, East Macedonia and Thrace, Greece
- AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416) - Vitória, Espírito Santo, Brazil
- Zhongshan Hospital Affiliated to Xiamen University ( Site 2213) - Xiamen, Fujian, China
- The First Affiliated Hospital of Xiamen University. ( Site 2239) - Xiamen, Fujian, China
- Radboudumc ( Site 1504) - Nijmegen, Gelderland, Netherlands
- Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807) - Girona, Gerona, Spain
- Guangxi Medical University Cancer Hospital ( Site 2202) - Nanning, Guangxi, China
- Fourth Hospital of Hebei Medical University ( Site 2201) - Shijiazhuang, Hebei, China
- Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206) - Wuhan, Hubei, China
- Hubei Cancer Hospital ( Site 2203) - Wuhan, Hubei, China
- The Second Xiangya Hospital Of Central South University ( Site 2207) - Changsha, Hunan, China
- Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006) - Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
- Nanjing Drum Tower Hospital ( Site 2224) - Nanjing, Jiangsu, China
- Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013) - Kropyvnytskyi, Kirovohrad Oblast, Ukraine
- Ukrainian Center of Tomotherapy ( Site 2014) - Kropyvnytskyi, Kirovohrad Oblast, Ukraine
- Kyiv City Clinical Oncology Center ( Site 2015) - Kyiv, Kyivska Oblast, Ukraine
- Shalimov Institute of Surgery and Transplantation ( Site 2003) - Kyiv, Kyivska Oblast, Ukraine
- National Cancer Center ( Site 2505) - Goyang-si, Kyonggi-do, South Korea
- Ajou University Hospital ( Site 2504) - Suwon, Kyonggi-do, South Korea
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401) - Rome, Lazio, Italy
- Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009) - Lviv, Lviv Oblast, Ukraine
- Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000) - Lviv, Lviv Oblast, Ukraine
- Sendai Kousei Hospital ( Site 2300) - Sendai, Miyagi, Japan
- Northern Beaches Hospital ( Site 2401) - Frenchs Forest, New South Wales, Australia
- Clinique Teissier Groupe ( Site 1006) - Valenciennes, Nord, France
- Chungbuk National University Hospital ( Site 2502) - Cheongju-si, North Chungcheong, South Korea
- Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108) - Münster, North Rhine-Westphalia, Germany
- Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011) - Odesa, Odesa Oblast, Ukraine
- Princess Alexandra Hospital ( Site 2406) - Woolloongabba, Queensland, Australia
- ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001) - Rivne, Rivne Oblast, Ukraine
Showing 60 of 73 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →