A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT07554339

Run by

Merck Sharp & Dohme LLC

People needed

310

Starts

2026-06-18

Expected to finish

2037-08-17

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• New York Oncology Hematology P.C ( Site 9000) — Albany, New York, United States (enrolling)
• Clinica Adventista Belgrano ( Site 0304) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303) — Mar del Plata, Buenos Aires, Argentina (enrolling)
• Hospital Britanico de Buenos Aires ( Site 0305) — Buenos Aires, Buenos Aires F.D., Argentina (enrolling)
• Sanatorio Parque ( Site 0302) — Rosario, Santa Fe Province, Argentina (enrolling)
• Zhongshan Hospital Affiliated to Xiamen University ( Site 2213) — Xiamen, Fujian, China (enrolling)
• The First Affiliated Hospital of Xiamen University. ( Site 2239) — Xiamen, Fujian, China (enrolling)
• Guangxi Medical University Affiliated Tumor Hospital ( Site 2202) — Qingxiu District, Guangxi, China (enrolling)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206) — Wuhan, Hubei, China (enrolling)
• Hubei Cancer Hospital ( Site 2203) — Wuhan, Hubei, China (enrolling)
• Nanjing Drum Tower Hospital ( Site 2224) — Nanjing, Jiangsu, China (enrolling)
• Shandong Cancer Hospital ( Site 2200) — Jinan, Shandong, China (enrolling)
• Zhongshan Hospital affiliated to Fudan University ( Site 2215) — Shanghai, Shanghai Municipality, China (enrolling)
• Shanxi Provincial Cancer Hospital ( Site 2227) — Taiyuan, Shanxi, China (enrolling)
• Sichuan Cancer hospital. ( Site 2218) — Chengdu, Sichuan, China (enrolling)
• Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108) — Münster, North Rhine-Westphalia, Germany (enrolling)
• Athens Medical Center ( Site 1201) — Athens, Attica, Greece (enrolling)
• Metaxa Cancer Hospital of Piraeus ( Site 1203) — Piraeus, Attica, Greece (enrolling)
• University General Hospital of Alexandroupoli ( Site 1206) — Alexandroupoli, East Macedonia and Thrace, Greece (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401) — Rome, Lazio, Italy (enrolling)
• Radboudumc ( Site 1504) — Nijmegen, Gelderland, Netherlands (enrolling)
• Leids Universitair Medisch Centrum ( Site 1503) — Leiden, South Holland, Netherlands (enrolling)
• University Medical Center Groningen ( Site 1505) — Groningen, Netherlands (enrolling)
• National Cancer Center ( Site 2505) — Goyang-si, Kyonggi-do, South Korea (enrolling)
• NHO Revive Research Institute LLC ( Site 0118) — Lincoln, Nebraska, United States (enrolling)

Full record on ClinicalTrials.gov

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