A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
Condition(s) studied
Investigational drug(s) / intervention(s)
Calderasib: Tablet for oral administration.
Durvalumab: Solution for intravenous (IV) infusion.
Placebo to MK-1084: Placebo to MK-1084.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) — Up to approximately 6 years
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Trial sites (107)
| Facility | City | Region | Status |
|---|---|---|---|
| Low Country Cancer Care ( Site 0155) | Savannah | Georgia | Recruiting |
| Duly Healthcare ( Site 0158) | Lisle | Illinois | Recruiting |
| NHO Revive Research Institute LLC ( Site 0118) | Lincoln | Nebraska | Recruiting |
| New York Oncology Hematology P.C ( Site 9000) | Albany | New York | Recruiting |
| WakeMed Raleigh Campus ( Site 0144) | Raleigh | North Carolina | Recruiting |
| Virginia Cancer Specialists ( Site 0114) | Fairfax | Virginia | Recruiting |
| Instituto Alexander Fleming ( Site 0301) | Ciudad Autonoma de Buenos Aires. | Buenos Aires | Recruiting |
| Hospital Italiano de Buenos Aires. ( Site 0300) | Ciudad Autonoma de Buenos Aires | Buenos Aires | Recruiting |
| Clinica Adventista Belgrano ( Site 0304) | Ciudad Autonoma de Buenos Aires | Buenos Aires | Recruiting |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303) | Mar del Plata | Buenos Aires | Recruiting |
| Hospital Britanico de Buenos Aires ( Site 0305) | Buenos Aires | Buenos Aires F.D. | Recruiting |
| Sanatorio Parque ( Site 0302) | Rosario | Santa Fe Province | Recruiting |
| Northern Beaches Hospital ( Site 2401) | Frenchs Forest | New South Wales | Recruiting |
| Mater Misericordiae Limited ( Site 2402) | South Brisbane | Queensland | Recruiting |
| Princess Alexandra Hospital ( Site 2406) | Woolloongabba | Queensland | Recruiting |
| Frankston Hospital ( Site 2403) | Frankston | Victoria | Recruiting |
| CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0406) | Fortaleza | Ceará | Recruiting |
| AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416) | Vitória | Espírito Santo | Recruiting |
| CEPON ( Site 0413) | Florianópolis | Santa Catarina | Recruiting |
| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401) | Barretos | São Paulo | Recruiting |
| Anhui Provincial Cancer Hospital ( Site 2209) | Hefei | Anhui | Recruiting |
| Beijing Cancer hospital ( Site 2226) | Beijing | Beijing Municipality | Recruiting |
| Beijing Peking Union Medical College Hospital ( Site 2220) | Beijing | Beijing Municipality | Recruiting |
| Zhongshan Hospital Affiliated to Xiamen University ( Site 2213) | Xiamen | Fujian | Recruiting |
| The First Affiliated Hospital of Xiamen University. ( Site 2239) | Xiamen | Fujian | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University ( Site 2211) | Guangzhou | Guangdong | Recruiting |
| The Second Affiliated Hospital of Guilin Medical University ( Site 2212) | Guilin | Guangxi | Recruiting |
| Guangxi Medical University Cancer Hospital ( Site 2202) | Nanning | Guangxi | Recruiting |
| Fourth Hospital of Hebei Medical University ( Site 2201) | Shijiazhuang | Hebei | Recruiting |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206) | Wuhan | Hubei | Recruiting |
| Hubei Cancer Hospital ( Site 2203) | Wuhan | Hubei | Recruiting |
| The Second Xiangya Hospital Of Central South University ( Site 2207) | Changsha | Hunan | Recruiting |
| Hunan Cancer Hospital ( Site 2214) | Changsha | Hunan | Recruiting |
| Nanjing Drum Tower Hospital ( Site 2224) | Nanjing | Jiangsu | Recruiting |
| Shandong Cancer Hospital ( Site 2200) | Jinan | Shandong | Recruiting |
| Zhongshan Hospital affiliated to Fudan University ( Site 2215) | Shanghai | Shanghai Municipality | Recruiting |
| Fudan University Shanghai Cancer Center ( Site 2216) | Shanghai | Shanghai Municipality | Recruiting |
| Shanxi Provincial Cancer Hospital ( Site 2227) | Taiyuan | Shanxi | Recruiting |
| Sichuan Cancer hospital. ( Site 2218) | Chengdu | Sichuan | Recruiting |
| Chongqing University Cancer Hospital ( Site 2236) | Chongqing | Sichuan | Recruiting |
+ 67 more sites — see the full list on the official registry below.
On this site
📄 Imfinzi (durvalumab) drug profile →More Merck Sharp & Dohme LLC trials in the USA
Other trials for the same condition
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 NCT07554339 on ClinicalTrials.gov ↗ ← All trials in the USA