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

NCT07554339 | Recruiting Phase 3 DMC FDA Drug

• 6 other identifiers: 1084-0152025-522038-29-00U1111-1321-6971MK-1084-015KANDLELIT-015jRCT2021260021
• Study Type: interventional
• Target: 310
• Locations: 10 countries
• Sites: 50

Brief 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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

  Up to approximately 6 years

Secondary Outcomes (9)

• Overall Survival (OS)

  Up to approximately 9 years

• Number of Participants Who Experience an Adverse Events (AEs)

  Up to approximately 9 years

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 9 years

• Objective Response Rate (ORR)

  Up to approximately 9 years

• Duration of Response (DOR)

  Up to approximately 9 years

Study Arms (2)

Calderasib + Durvalumab

EXPERIMENTAL

Participants will receive calderasib and durvalumab.

Drug: Calderasib; Biological: Durvalumab

Placebo + Durvalumab

ACTIVE COMPARATOR

Participants will receive placebo to calderasib and durvalumab.

Biological: Durvalumab; Other: Placebo to MK-1084

Interventions

Calderasib DRUG

Tablet for oral administration.

Also known as: MK-1084

Calderasib + Durvalumab

Durvalumab BIOLOGICAL

Solution for intravenous (IV) infusion.

Also known as: IMFINZI®

Calderasib + Durvalumab; Placebo + Durvalumab

Placebo to MK-1084 OTHER

Placebo to MK-1084.

Placebo + Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (50)

NHO Revive Research Institute LLC ( Site 0118)

Lincoln, Nebraska, 68506, United States

RECRUITING

New York Oncology Hematology P.C ( Site 9000)

Albany, New York, 12206, United States

RECRUITING

Clinica Adventista Belgrano ( Site 0304)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1430EGF, Argentina

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Hospital Britanico de Buenos Aires ( Site 0305)

Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

RECRUITING

Sanatorio Parque ( Site 0302)

Rosario, Santa Fe Province, S2000DSV, Argentina

RECRUITING

Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)

Xiamen, Fujian, 361000, China

RECRUITING

The First Affiliated Hospital of Xiamen University. ( Site 2239)

Xiamen, Fujian, 361003, China

RECRUITING

Guangxi Medical University Affiliated Tumor Hospital ( Site 2202)

Qingxiu District, Guangxi, 530022, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206)

Wuhan, Hubei, 430048, China

RECRUITING

Hubei Cancer Hospital ( Site 2203)

Wuhan, Hubei, 430070, China

RECRUITING

Nanjing Drum Tower Hospital ( Site 2224)

Nanjing, Jiangsu, 210000, China

RECRUITING

Shandong Cancer Hospital ( Site 2200)

Jinan, Shandong, 250117, China

RECRUITING

Zhongshan Hospital affiliated to Fudan University ( Site 2215)

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Shanxi Provincial Cancer Hospital ( Site 2227)

Taiyuan, Shanxi, 030013, China

RECRUITING

Sichuan Cancer hospital. ( Site 2218)

Chengdu, Sichuan, 610213, China

RECRUITING

Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)

Münster, North Rhine-Westphalia, 48153, Germany

RECRUITING

Athens Medical Center ( Site 1201)

Athens, Attica, 151 25, Greece

RECRUITING

Metaxa Cancer Hospital of Piraeus ( Site 1203)

Piraeus, Attica, 185 37, Greece

RECRUITING

University General Hospital of Alexandroupoli ( Site 1206)

Alexandroupoli, East Macedonia and Thrace, 681 00, Greece

RECRUITING

Radboudumc ( Site 1504)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Leids Universitair Medisch Centrum ( Site 1503)

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

University Medical Center Groningen ( Site 1505)

Groningen, 9713 GZ, Netherlands

RECRUITING

National Cancer Center ( Site 2505)

Goyang-si, Kyonggi-do, 10408, South Korea

RECRUITING

Ajou University Hospital ( Site 2504)

Suwon, Kyonggi-do, 16499, South Korea

RECRUITING

Chungbuk National University Hospital ( Site 2502)

Cheongju-si, North Chungcheong, 28644, South Korea

RECRUITING

Keimyung University Dongsan Hospital ( Site 2503)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System ( Site 2501)

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center ( Site 2500)

Seoul, 05505, South Korea

RECRUITING

Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807)

Girona, Gerona, 17007, Spain

RECRUITING

Fundación Instituto Valenciano de Oncología ( Site 1809)

Valencia, Valenciana, Comunitat, 46009, Spain

RECRUITING

Hospital Clinico San Carlos ( Site 1810)

Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz ( Site 1808)

Madrid, 28046, Spain

RECRUITING

Hospital Universitario Virgen Macarena ( Site 1805)

Seville, 41007, Spain

RECRUITING

Taipei Medical University Shuang Ho Hospital ( Site 2612)

New Taipei City, 23561, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 2601)

Tainan, 704, Taiwan

RECRUITING

Mackay Memorial Hospital ( Site 2611)

Taipei, 10449, Taiwan

RECRUITING

Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002)

Chernivtsi, Chernivetska Oblast, 58013, Ukraine

RECRUITING

Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012)

Kryvyi Rih, Dnipropetrovsk Oblast, 50000, Ukraine

RECRUITING

Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

RECRUITING

Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)

Kropyvnytskyi, Kirovohrad Oblast, 25006, Ukraine

RECRUITING

Ukrainian Center of Tomotherapy ( Site 2014)

Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine

RECRUITING

Shalimov Institute of Surgery and Transplantation ( Site 2003)

Kyiv, Kyivska Oblast, 03680, Ukraine

RECRUITING

Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009)

Lviv, Lviv Oblast, 79031, Ukraine

RECRUITING

Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000)

Lviv, Lviv Oblast, 79059, Ukraine

RECRUITING

Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)

Odesa, Odesa Oblast, 65025, Ukraine

RECRUITING

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)

Rivne, Rivne Oblast, 33010, Ukraine

RECRUITING

Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004)

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

RECRUITING

Volyn Regional Clinical Hospital ( Site 2010)

Lutsk, Volyn Oblast, 43018, Ukraine

RECRUITING

Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005)

Kyiv, 03057, Ukraine

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): December 15, 2032
• Study Completion (Estimated): August 17, 2037
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (3); CN (10); DE (1); AR (4); GR (3); ES (5); KR (6); US (2); TW (3); UA (13)