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A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT ID: NCT07190248

Last Updated: 2026-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

675 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2032-08-06

Brief Summary

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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.

Related Clinical Trials

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A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)

NCT06345729

Non-small Cell Lung Cancer
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Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)

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Non-Small-Cell Lung Carcinoma
COMPLETED PHASE3

Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)

NCT02220894

Non-small Cell Lung Cancer
COMPLETED PHASE3

Biomarkers of Response to Pembrolizumab Combined With Chemotherapy in Non-Small Cell Lung Cancer (KEYNOTE-782, MK-3475-782)

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Non-Small Cell Lung Cancer
COMPLETED PHASE2

Carboplatin, Pemetrexed, and Panitumumab in Patients With Advanced Non-Squamous K-ras Wild Type NSCLC

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Non-Small-Cell Lung Cancer
COMPLETED PHASE2

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Calderasib + Pembrolizumab (+) Berahyaluronidase alfa

Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) plus calderasib until discontinuation criterion is met.

Group Type EXPERIMENTAL

Calderasib

Intervention Type DRUG

Administered as an oral tablet

Pembrolizumab (+) Berahyaluronidase alfa

Intervention Type BIOLOGICAL

Administered as a SC injection

Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy

Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) and pemetrexed via intravenous (IV) infusion at a dose of 500 mg/m\^2 on days 1 and 22 of cycles 1 and 3 until discontinuation criterion is met PLUS investigator's choice of carboplatin via IV infusion at area under curve (AUC) 5 mg/mL/minute on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks) OR cisplatin via IV infusion at a dose of 75 mg/m\^2 on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks).

Group Type ACTIVE_COMPARATOR

Pembrolizumab (+) Berahyaluronidase alfa

Intervention Type BIOLOGICAL

Administered as a SC injection

Pemetrexed

Intervention Type DRUG

Administered as an IV Infusion

Cisplatin

Intervention Type DRUG

Administered as an IV Infusion

Carboplatin

Intervention Type DRUG

Administered as an IV Infusion

Interventions

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Calderasib

Administered as an oral tablet

Intervention Type DRUG

Pembrolizumab (+) Berahyaluronidase alfa

Administered as a SC injection

Intervention Type BIOLOGICAL

Pemetrexed

Administered as an IV Infusion

Intervention Type DRUG

Cisplatin

Administered as an IV Infusion

Intervention Type DRUG

Carboplatin

Administered as an IV Infusion

Intervention Type DRUG

Other Intervention Names

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MK-1084 MK-3475A Alimta Platinol-AQ PARAPLATIN®

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Hospital Universitario Ramon y Cajal ( Site 2203)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de Valme ( Site 2205)

Seville, , Spain

Site Status RECRUITING

Chang Gung Memorial Hospital- Chiayi ( Site 3611)

Chiayi City, Chiayi, Taiwan

Site Status RECRUITING

Central Alabama Research ( Site 0108)

Birmingham, Alabama, United States

Site Status RECRUITING

Stamford Hospital ( Site 0126)

Stamford, Connecticut, United States

Site Status RECRUITING

Mount Sinai Cancer Center ( Site 0137)

Miami Beach, Florida, United States

Site Status RECRUITING

New England Cancer Specialists ( Site 0139)

Westbrook, Maine, United States

Site Status RECRUITING

New York Oncology Hematology, P.C. ( Site 0119)

Albany, New York, United States

Site Status RECRUITING

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)

Lancaster, Pennsylvania, United States

Site Status RECRUITING

Blue Ridge Cancer Care ( Site 0144)

Roanoke, Virginia, United States

Site Status RECRUITING

Instituto Alexander Fleming ( Site 0311)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)

Mar del Plata, Buenos Aires, Argentina

Site Status RECRUITING

Hospital Italiano de Cordoba ( Site 0308)

Córdoba, , Argentina

Site Status RECRUITING

CEMAIC ( Site 0309)

Córdoba, , Argentina

Site Status RECRUITING

Genesis Care- Campbelltown ( Site 2907)

Campbelltown, New South Wales, Australia

Site Status RECRUITING

Northern Beaches Hospital ( Site 2905)

Frenchs Forest, New South Wales, Australia

Site Status RECRUITING

Mater Hospital Brisbane ( Site 2906)

South Brisbane, Queensland, Australia

Site Status RECRUITING

Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)

Graz, Styria, Austria

Site Status RECRUITING

Anhui Provincial Cancer Hospital ( Site 2708)

Hefei, Anhui, China

Site Status RECRUITING

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2700)

Beijing, Beijing Municipality, China

Site Status RECRUITING

Zhujiang Hospital of Southern Medical University ( Site 2744)

Guangzhou, Guangdong, China

Site Status RECRUITING

Affiliated Cancer Hospital of Guangxi Medical University ( Site 2704)

Nanning, Guangxi, China

Site Status RECRUITING

Sichuan Cancer Hospital. ( Site 2739)

Chengdu, Sichuan, China

Site Status RECRUITING

Hopital Europeen Marseille ( Site 1207)

Marseille, Bouches-du-Rhone, France

Site Status RECRUITING

CHU Caen ( Site 1212)

Caen, Calvados, France

Site Status RECRUITING

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1209)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Site Status RECRUITING

Centre Hospitalier Metropole Savoie Site de Chambery ( Site 1208)

Chambéry, Savoie, France

Site Status RECRUITING

Clinique de l'Europe ( Site 1213)

Amiens, Somme, France

Site Status RECRUITING

Groupe Hospitalier Paris Saint Joseph ( Site 1215)

Paris, , France

Site Status RECRUITING

Hôpital Européen Georges Pompidou ( Site 1214)

Paris, , France

Site Status RECRUITING

Agios Andreas Hospital Patras ( Site 1407)

Pátrai, Achaia, Greece

Site Status RECRUITING

Errikos Dunant Hospital Center ( Site 1408)

Athens, Attica, Greece

Site Status RECRUITING

Metropolitan General Hospital ( Site 1400)

Athens, Attica, Greece

Site Status RECRUITING

Papageorgiou General Hospital of Thessaloniki ( Site 1403)

Thessaloniki, , Greece

Site Status RECRUITING

Reformatus Pulmonologiai Centrum ( Site 1503)

Törökbálint, Pest County, Hungary

Site Status RECRUITING

Yitzhak Shamir Medical Center. ( Site 1709)

Beer Ya Akov, , Israel

Site Status RECRUITING

Shaare Zedek Medical Center ( Site 1706)

Jerusalem, , Israel

Site Status RECRUITING

Meir Medical Center. ( Site 1702)

Kfar Saba, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 1700)

Ramat Gan, , Israel

Site Status RECRUITING

Sourasky Medical Center ( Site 1705)

Tel Aviv, , Israel

Site Status RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1811)

Bergamo, Lombardy, Italy

Site Status RECRUITING

AOU Renato Dulbecco ( Site 1804)

Catanzaro, , Italy

Site Status RECRUITING

National Hospital Organization Himeji Medical Center ( Site 2827)

Himeji, Hyōgo, Japan

Site Status RECRUITING

Kobe City Medical Center General Hospital ( Site 2811)

Kobe, Hyōgo, Japan

Site Status RECRUITING

Matsusaka Municipal Hospital ( Site 2808)

Matsusaka, Mie-ken, Japan

Site Status RECRUITING

Tohoku University Hospital ( Site 2804)

Sendai, Miyagi, Japan

Site Status RECRUITING

Osaka Medical and Pharmaceutical University Hospital ( Site 2810)

Takatsuki, Osaka, Japan

Site Status RECRUITING

National Hospital Organization Ureshino Medical Center ( Site 2817)

Ureshino, Saga-ken, Japan

Site Status RECRUITING

Nippon Medical School Hospital ( Site 2819)

Bunkyo, Tokyo, Japan

Site Status RECRUITING

Tokyo Medical University Hospital ( Site 2829)

Shinjuku, Tokyo, Japan

Site Status RECRUITING

National Hospital Organization Kyushu Medical Center ( Site 2801)

Fukuoka, , Japan

Site Status RECRUITING

Saiseikai Kumamoto Hospital ( Site 2816)

Kumamoto, , Japan

Site Status RECRUITING

Osaka Metropolitan University Hospital ( Site 2826)

Osaka, , Japan

Site Status RECRUITING

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2012)

Gliwice, Silesian Voivodeship, Poland

Site Status RECRUITING

Spitalul Clinic Colțea ( Site 2102)

Bucharest, București, Romania

Site Status RECRUITING

Institutul Oncologic Prof. Dr. I Chiricuta ( Site 2103)

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2101)

Florești, Cluj, Romania

Site Status RECRUITING

SC ONCO CARD SRL ( Site 2109)

Brasov, , Romania

Site Status RECRUITING

Delta Health Care SRL ( Site 2108)

Bucharest, , Romania

Site Status RECRUITING

SC MNT Healthcare Europe SRL ( Site 2105)

Bucharest, , Romania

Site Status RECRUITING

Chonnam National University Hwasun Hospital ( Site 3502)

Jeollanam-do, Jeonranamdo, South Korea

Site Status RECRUITING

Pusan National University Yangsan Hospital ( Site 3504)

Yangsan, Kyongsangnam-do, South Korea

Site Status RECRUITING

Pusan National University Hospital ( Site 3501)

Busan, Pusan-Kwangyokshi, South Korea

Site Status RECRUITING

Chungnam National University Hospital ( Site 3503)

Daejeon, Taejon-Kwangyokshi, South Korea

Site Status RECRUITING

Kyung Hee University Medical Center ( Site 3500)

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital ( Site 3505)

Seoul, , South Korea

Site Status RECRUITING

Institut Català d'Oncologia (ICO) - Badalona ( Site 2200)

Badalona, Catalonia, Spain

Site Status RECRUITING

HOSPITAL CLÍNIC DE BARCELONA ( Site 2201)

Barcelona, Catalonia, Spain

Site Status RECRUITING

Complejo Hospitalario Universitario A Coruna ( Site 2207)

A Coruña, La Coruna, Spain

Site Status RECRUITING

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 2202)

Majadahonda, Madrid, Comunidad de, Spain

Site Status RECRUITING

Hospital General Universitario de Valencia ( Site 2204)

Valencia, Valenciana, Comunitat, Spain

Site Status RECRUITING

Taipei Medical University Shuang Ho Hospital ( Site 3602)

New Taipei City, , Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital ( Site 3604)

Tainan, , Taiwan

Site Status RECRUITING

MacKay Memorial Hospital ( Site 3609)

Taipei, , Taiwan

Site Status RECRUITING

Tri-Service General Hospital ( Site 3603)

Taipei, , Taiwan

Site Status RECRUITING

Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2504)

Chernivtsi, Chernivetska Oblast, Ukraine

Site Status RECRUITING

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)

Rivne, Rivne Oblast, Ukraine

Site Status RECRUITING

Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512)

Kyiv, , Ukraine

Site Status RECRUITING

Universal Clinic Oberig ( Site 2506)

Kyiv, , Ukraine

Site Status RECRUITING

Countries

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United States Argentina Australia Austria China France Greece Hungary Israel Italy Japan Poland Romania South Korea Spain Taiwan Ukraine

Central Contacts

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Toll Free Number

Role: CONTACT

[email protected]
1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

205-949-1907

Study Coordinator

Role: primary

203-276-2695

Study Coordinator

Role: primary

305-674-2625

Study Coordinator

Role: primary

207-303-3300

Study Coordinator

Role: primary

518-489-3612

Study Coordinator

Role: primary

717-544-9400

Study Coordinator

Role: primary

540-982-0237

Study Coordinator

Role: primary

+5491166936669

Study Coordinator

Role: primary

+542234963224

Study Coordinator

Role: primary

+543514106550

Study Coordinator

Role: primary

+543513976568

Study Coordinator

Role: primary

+610246325500

Study Coordinator

Role: primary

+61291055000

Study Coordinator

Role: primary

+61731631369

Study Coordinator

Role: primary

+4331638578055

Study Coordinator

Role: primary

0551-65320585

Study Coordinator

Role: primary

（010）88196949

Study Coordinator

Role: primary

02061643888

Study Coordinator

Role: primary

07715331955

Study Coordinator

Role: primary

028-85420509

Study Coordinator

Role: primary

+33413427237

Study Coordinator

Role: primary

003323106 3106

Study Coordinator

Role: primary

+33383157853

Study Coordinator

Role: primary

+334 79 96 58 13

Study Coordinator

Role: primary

+330360125235

Study Coordinator

Role: primary

33 1 44 12 33 33

Study Coordinator

Role: primary

+33156093473

Study Coordinator

Role: primary

+302613601000

Study Coordinator

Role: primary

+302106972246

Study Coordinator

Role: primary

+302106502542

Study Coordinator

Role: primary

+302313323959

Study Coordinator

Role: primary

+36307005601

Study Coordinator

Role: primary

+97289542196

Study Coordinator

Role: primary

+97226555999

Study Coordinator

Role: primary

+97297472555

Study Coordinator

Role: primary

+97235303030

Study Coordinator

Role: primary

97236974444

Study Coordinator

Role: primary

+39035267111

Study Coordinator

Role: primary

+390961883771

Study Coordinator

Role: primary

+81-79-225-3211

Study Coordinator

Role: primary

+81-78-302-4321

Study Coordinator

Role: primary

+81-598-23-1515

Study Coordinator

Role: primary

+81-22-717-7000

Study Coordinator

Role: primary

+81-72-683-1221

Study Coordinator

Role: primary

+81-954-43-1120

Study Coordinator

Role: primary

+81-3-3822-2131

Study Coordinator

Role: primary

+81-3-3342-6111

Study Coordinator

Role: primary

+81-92-852-0700

Study Coordinator

Role: primary

+81-96-351-8000

Study Coordinator

Role: primary

+81-6-6645-2121

Study Coordinator

Role: primary

+48322789791

Study Coordinator

Role: primary

+40213874100

Study Coordinator

Role: primary

+40264598362

Study Coordinator

Role: primary

+40219368

Study Coordinator

Role: primary

+40 268960

Study Coordinator

Role: primary

+40 21 9977

Study Coordinator

Role: primary

+40 31 630 0000

Study Coordinator

Role: primary

82-61-379-7614

Study Coordinator

Role: primary

8215777512

Study Coordinator

Role: primary

+82512407889

Study Coordinator

Role: primary

+82-42-280-8035

Study Coordinator

Role: primary

8229588511

Study Coordinator

Role: primary

+82226261914

Study Coordinator

Role: primary

+34934978387

Study Coordinator

Role: primary

+34913368023

Study Coordinator

Role: primary

+34981178000ext92872

Study Coordinator

Role: primary

+34911916671

Study Coordinator

Role: primary

+34 963187527

Study Coordinator

Role: primary

+34913368023

Study Coordinator

Role: primary

+34955015273

Study Coordinator

Role: primary

+88653621000

Study Coordinator

Role: primary

+886970746943

Study Coordinator

Role: primary

+88662353535x3120

Study Coordinator

Role: primary

+886225433535

Study Coordinator

Role: primary

+886287923311x13899

Study Coordinator

Role: primary

380443344770

Study Coordinator

Role: primary

+38050 380 29 15

Study Coordinator

Role: primary

+380939720596

Study Coordinator

Role: primary

+380445213003

Related Links

Access external resources that provide additional context or updates about the study.

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://www.trialsummaries.com/Study/StudyDetails?id=27064&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

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U1111-1307-9569

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-514500-14-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-1084-007

Identifier Type: OTHER

Identifier Source: secondary_id

KANDLELIT-007

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031240722

Identifier Type: REGISTRY

Identifier Source: secondary_id

1084-007

Identifier Type: -

Identifier Source: org_study_id

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