AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3NCT07190248

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

A Phase 3 study testing Calderasib, Pembrolizumab (+) Berahyaluronidase alfa and Pemetrexed in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 221 sites in 30 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Calderasib, Pembrolizumab (+) Berahyaluronidase alfa and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
675 participants
Where
221 sitesin 30 countries
Study dates
8 Oct 2025to 6 Aug 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • 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)

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

221 sites in 30 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

221 sites in 30 countries

China31 sites, 30 recruiting

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

    Beijing, Beijing Municipality, 100142

    Study Coordinator, （010）88196949

    Recruiting

  • Beijing Peking Union Medical College Hospital ( Site 2702)

    Beijing, Beijing Municipality, 100730

    Study Coordinator, +8601069151169

    Recruiting

  • Xiangya Hospital Central South University ( Site 2741)

    Changsha, Hunan, 410008

    Study Coordinator, 0731-89753999

    Recruiting

  • Hunan Cancer Hospital ( Site 2710)

    Changsha, Hunan, 410013

    Study Coordinator, 0731-88651669

    Recruiting

  • Sichuan Cancer Hospital. ( Site 2739)

    Chengdu, Sichuan, 610213

    Study Coordinator, 028-85420509

    Recruiting

  • West China Hospital Sichuan University ( Site 2735)

    Chengdu, Sichuan, 611135

    Study Coordinator, 028-85422114

    Recruiting

  • Chongqing University Cancer Hospital ( Site 2736)

    Chongqing, Sichuan, 400030

    Study Coordinator, 023-65301682

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University ( Site 2701)

    Fujian, Fujian, 350005

    Study Coordinator, 0591 8798 3333

    Recruiting

  • Fujian Provincial Cancer Hospital ( Site 2706)

    Fuzhou, Fujian, 350014

    Study Coordinator, 0591-83660063

    Recruiting

  • The First Affiliated Hospital of Xiamen University ( Site 2717)

    Fuzhou, Fujian, 361003

    Study Coordinator, 0592-2132222

    Recruiting

  • The First Affiliated Hospital.Sun Yat-sen University ( Site 2714)

    Guangzhou, Guangdong, 510080

    Study Coordinator, +8602087333133

    Recruiting

  • AFFILIATED CANCER HOSPITAL AND INSTITUTE OF GUANGZHOU MEDICAL UNIVERSITY ( Site 2743)

    Guangzhou, Guangdong, 510095

    Study Coordinator, 020-66673677

    Recruiting

  • Zhujiang Hospital of Southern Medical University ( Site 2744)

    Guangzhou, Guangdong, 510280

    Study Coordinator, 02061643888

    Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 2716)

    Hangzhou, Zhejiang, 310003

    Study Coordinator, 86 057187236114

    Recruiting

  • Sir Run Run Shaw Hospital ( Site 2731)

    Hangzhou, Zhejiang, 310015

    Study Coordinator, (0571)86090073

    Recruiting

  • Zhejiang Cancer Hospital ( Site 2727)

    Hangzhou, Zhejiang, 310022

    Study Coordinator, 0571-88128276

    Recruiting

  • Anhui Provincial Cancer Hospital ( Site 2708)

    Hefei, Anhui, 230031

    Study Coordinator, 0551-65320585

    Recruiting

  • JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 2745)

    Jiamusi, Heilongjiang, 154007

    Study Coordinator, 0454-8782000

    Recruiting

  • Yunnan Province Cancer Hospital ( Site 2734)

    Kunming, Yunnan, 650118

    Study Coordinator, 0871-68189037

    Recruiting

  • LinYi Cancer Hospital ( Site 2737)

    Linyi, Shandong, 276000

    Study Coordinator, +8605398127192

    Recruiting

  • Jiangxi Cancer Hospital ( Site 2725)

    Nanchang, Jiangxi, 330029

    Study Coordinator, 18170058120

    Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 2715)

    Nanjing, Jiangsu, 210000

    Active, not recruiting

  • Affiliated Cancer Hospital of Guangxi Medical University ( Site 2704)

    Nanning, Guangxi, 530021

    Study Coordinator, 07715331955

    Recruiting

  • Shanghai Chest Hospital ( Site 2747)

    Shanghai, Shanghai Municipality, 200030

    Study Coordinator, （021）6282 1990

    Recruiting

  • Shanghai Pulmonary Hospital-Oncology Department ( Site 2723)

    Shanghai, Shanghai Municipality, 200433

    Study Coordinator, 021-65115006

    Recruiting

  • Shanxi Cancer Hospital ( Site 2728)

    Taiyuan, Shanxi, 030013

    Study Coordinator, +863514651680

    Recruiting

  • Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2724)

    Taizhou, Zhejiang, 317000

    Study Coordinator, 0576-8512 0120

    Recruiting

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 2722)

    Wuhan, Hubei, 430030

    Study Coordinator, 027-83663940

    Recruiting

  • Hubei Cancer Hospital ( Site 2721)

    Wuhan, Hubei, 430079

    Study Coordinator, 027-87670003

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2729)

    Xi'an, Shaanxi, 710061

    Study Coordinator, 029-85323338

    Recruiting

  • Henan Cancer Hospital ( Site 2746)

    Zhengzhou, Henan, 450008

    Study Coordinator, +86037165588007

    Recruiting

Other trials in China

Japan29 sites, 28 recruiting

  • Nippon Medical School Hospital ( Site 2819)

    Bunkyo, Tokyo, 113-8603

    Study Coordinator, +81-3-3822-2131

    Recruiting

  • Tokyo Metropolitan Komagome Hospital ( Site 2823)

    Bunkyo, Tokyo, 113-8677

    Study Coordinator, +81-3-3823-2101

    Recruiting

  • Chiba University Hospital ( Site 2812)

    Chiba, 260-8677

    Study Coordinator, +81-43-222-7171

    Recruiting

  • National Hospital Organization Kyushu Medical Center ( Site 2801)

    Fukuoka, 810-8563

    Study Coordinator, +81-92-852-0700

    Recruiting

  • National Hospital Organization Himeji Medical Center ( Site 2827)

    Himeji, Hyōgo, 670-8520

    Study Coordinator, +81-79-225-3211

    Recruiting

  • Kansai Medical University Hospital ( Site 2809)

    Hirakata, Osaka, 573-1191

    Study Coordinator, +81-72-804-0101

    Recruiting

  • Hirosaki University Hospital ( Site 2818)

    Hirosaki, Aomori, 036-8563

    Study Coordinator, +81-172-33-5111

    Recruiting

  • Hiroshima City Hiroshima Citizens Hospital ( Site 2821)

    Hiroshima, 730-8518

    Study Coordinator, +81-82-221-2291

    Recruiting

  • Kanazawa University Hospital ( Site 2805)

    Kanazawa, Ishikawa-ken, 920-8641

    Study Coordinator, +81-76-265-2000

    Recruiting

  • St. Marianna University Hospital ( Site 2814)

    Kawasaki, Kanagawa, 216-8511

    Study Coordinator, +81-44-977-8111

    Recruiting

  • Kobe City Medical Center General Hospital ( Site 2811)

    Kobe, Hyōgo, 650-0047

    Study Coordinator, +81-78-302-4321

    Recruiting

  • Saiseikai Kumamoto Hospital ( Site 2816)

    Kumamoto, 861-4193

    Study Coordinator, +81-96-351-8000

    Recruiting

  • Kurume University Hospital ( Site 2815)

    Kurume, Fukuoka, 830-0011

    Study Coordinator, +81-942-35-3311

    Recruiting

  • Saiseikai Matsusaka Municipal Hospital ( Site 2808)

    Matsusaka, Mie-ken, 515-8544

    Study Coordinator, +81-598-23-1515

    Recruiting

  • Aichi Cancer Center ( Site 2813)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

  • Osaka Metropolitan University Hospital ( Site 2826)

    Osaka, 545-8586

    Study Coordinator, +81-6-6645-2121

    Recruiting

  • Gunma Prefectural Cancer Center ( Site 2802)

    Ōta, Gunma, 373-8550

    Active, not recruiting

  • Toho University Omori Medical Center ( Site 2825)

    Ōta-ku, Tokyo, 143-8541

    Study Coordinator, +81-3-3762-4151

    Recruiting

  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 2822)

    Sakai, Osaka, 591-8555

    Study Coordinator, +81-72-252-3021

    Recruiting

  • Tohoku University Hospital ( Site 2804)

    Sendai, Miyagi, 980-8574

    Study Coordinator, +81-22-717-7000

    Recruiting

  • Tokyo Medical University Hospital ( Site 2829)

    Shinjuku, Tokyo, 160-0023

    Study Coordinator, +81-3-3342-6111

    Recruiting

  • National Center for Global Health and Medicine ( Site 2806)

    Shinjuku, Tokyo, 162-8655

    Study Coordinator, +81-3-3202-7181

    Recruiting

  • Takarazuka City Hospital ( Site 2828)

    Takarazuka, Hyōgo, 665-0827

    Study Coordinator, +81-797-87-1161

    Recruiting

  • Osaka Medical and Pharmaceutical University Hospital ( Site 2810)

    Takatsuki, Osaka, 569-8686

    Study Coordinator, +81-72-683-1221

    Recruiting

  • Ehime University Hospital ( Site 2800)

    Tōon, Ehime, 791-0295

    Study Coordinator, +81-89-964-5111

    Recruiting

  • Fujita Health University Hospital ( Site 2807)

    Toyoake, Aichi-ken, 470-1192

    Study Coordinator, +81-562-93-2111

    Recruiting

  • National Hospital Organization Ureshino Medical Center ( Site 2817)

    Ureshino, Saga-ken, 843-0393

    Study Coordinator, +81-954-43-1120

    Recruiting

  • Yokohama Municipal Citizen's Hospital ( Site 2824)

    Yokohama, Kanagawa, 221-0855

    Study Coordinator, +81-45-316-4580

    Recruiting

  • Kanagawa Cancer Center ( Site 2820)

    Yokohama, Kanagawa, 241-8515

    Study Coordinator, +81-45-520-2222

    Recruiting

Other trials in Japan

United States16 sites, 15 recruiting

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

    Albany, New York, 12206

    Study Coordinator, 518-489-3612

    Recruiting

  • St. Charles Health System, Inc ( Site 0146)

    Bend, Oregon, 97701

    Study Coordinator, 541-706-5800

    Recruiting

  • Central Alabama Research ( Site 0108)

    Birmingham, Alabama, 35209

    Study Coordinator, 205-949-1907

    Recruiting

  • University of Connecticut Health Center ( Site 0130)

    Farmington, Connecticut, 06030-8010

    Study Coordinator, 860-679-7816

    Recruiting

  • Hematology Oncology Associates of Fredericksburg ( Site 9550)

    Fredericksburg, Virginia, 22408

    Study Coordinator, 540-371-0079x360

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0152)

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-5900

    Recruiting

  • Indiana University Health Arnett Cancer Center ( Site 0116)

    Lafayette, Indiana, 47904

    Study Coordinator, 765-838-6885

    Recruiting

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

    Lancaster, Pennsylvania, 17601

    Study Coordinator, 717-544-9400

    Recruiting

  • Mount Sinai Cancer Center ( Site 0137)

    Miami Beach, Florida, 33140

    Completed

  • Bon Secours Cancer Institute at St. Francis ( Site 0148)

    Midlothian, Virginia, 23114

    Study Coordinator, 804-893-8717

    Recruiting

  • WVU Cancer Institute ( Site 0153)

    Morgantown, West Virginia, 26506

    Study Coordinator, 304-598-4500

    Recruiting

  • Blue Ridge Cancer Care ( Site 0144)

    Roanoke, Virginia, 24014

    Study Coordinator, 540-982-0237

    Recruiting

  • Wilmot Cancer Institute ( Site 0141)

    Rochester, New York, 14642

    Study Coordinator, 585-275-5830

    Recruiting

  • Low Country Cancer Care ( Site 0156)

    Savannah, Georgia, 31404

    Study Coordinator, 912-692-2000

    Recruiting

  • Stamford Hospital ( Site 0126)

    Stamford, Connecticut, 06902

    Study Coordinator, 203-276-2695

    Recruiting

  • New England Cancer Specialists ( Site 0139)

    Westbrook, Maine, 04092

    Study Coordinator, 207-303-3300

    Recruiting

Other trials in United States

Italy14 sites, 14 recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1811)

    Bergamo, Lombardy, 24127

    Study Coordinator, +39035267111

    Recruiting

  • Azienda Santiaria dell'Alto Adige, comprensorio di Bolzano ( Site 1818)

    Bolzano, Bozen, 39100

    Study Coordinator, +390471438953

    Recruiting

  • AOU Renato Dulbecco ( Site 1804)

    Catanzaro, 88100

    Study Coordinator, +390961883771

    Recruiting

  • AOU Careggi ( Site 1801)

    Florence, Tuscany, 50134

    Study Coordinator, +390554271415

    Recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)

    Meldola, Forli-Cesena, 47014

    Study Coordinator, +390543739100

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 1817)

    Milan, 20162

    Study Coordinator, +390264442291

    Recruiting

  • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 1815)

    Modena, Emilia-Romagna, 41124

    Study Coordinator, +390594223252

    Recruiting

  • A.O.R.N. Antonio Cardarelli ( Site 1810)

    Naples, 80131

    Study Coordinator, +39817472223

    Recruiting

  • Policlinico San Matteo ( Site 1802)

    Pavia, 27100

    Study Coordinator, +390382502511

    Recruiting

  • Azienda Ospedaliera S. Giovanni Addolorata ( Site 1805)

    Rome, Lazio, 00184

    Study Coordinator, +393476063165

    Recruiting

  • Istituto Clinico Humanitas ( Site 1812)

    Rozzano, Milano, 20089

    Study Coordinator, +39 0282244583

    Recruiting

  • Ospedale San Giuseppe Moscati ( Site 1816)

    Statte, Taranto, 74010

    Study Coordinator, +390994585810

    Recruiting

  • P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale ( Site 1813)

    Udine, Friuli Venezia Giulia, 33100

    Study Coordinator, +393339040187

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 1809)

    Verona, 37126

    Study Coordinator, +390458128120

    Recruiting

Other trials in Italy

Brazil9 sites, 9 recruiting

  • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410)

    Florianópolis, Santa Catarina, 88020-210

    Study Coordinator, +554833804828

    Recruiting

  • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412)

    Fortaleza, Ceará, 60336-232

    Study Coordinator, +55 85 3286 - 5934.

    Recruiting

  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400)

    Porto Alegre, Rio Grande do Sul, 90110-270

    Study Coordinator, +555133072943

    Recruiting

  • Real Hospital Portugues ( Site 0418)

    Recife, Pernambuco, 52010075

    Study Coordinator, +5581996214574

    Recruiting

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419)

    Ribeirão Preto, São Paulo, 14048-900

    Study Coordinator, +551636022014

    Recruiting

  • Faculdade de Medicina do ABC ( Site 0411)

    Santo André, São Paulo, 09060-870

    Study Coordinator, +55 11 4993-5491

    Recruiting

  • Hospital Alemao Oswaldo Cruz ( Site 0413)

    São Paulo, São Paulo, 01327-001

    Study Coordinator, +551135491542

    Recruiting

  • IBCC - Núcleo de Pesquisa e Ensino ( Site 0417)

    São Paulo, 04014-002

    Study Coordinator, +551144500360

    Recruiting

  • Hospital Santa Rita de Cassia ( Site 0403)

    Vitória, Espírito Santo, 29043-260

    Study Coordinator, +5527998469004

    Recruiting

Other trials in Brazil

France8 sites, 8 recruiting

  • Clinique de l'Europe ( Site 1213)

    Amiens, Somme, 80000

    Study Coordinator, +330360125235

    Recruiting

  • CHU Caen ( Site 1212)

    Caen, Calvados, 14000

    Study Coordinator, 003323106 3106

    Recruiting

  • Centre Hospitalier Metropole Savoie Site de Chambery ( Site 1208)

    Chambéry, Savoie, 73011

    Study Coordinator, +334 79 96 58 13

    Recruiting

  • Hopital Europeen Marseille ( Site 1207)

    Marseille, Bouches-du-Rhone, 13003

    Study Coordinator, +33413427237

    Recruiting

  • Groupe Hospitalier Paris Saint Joseph ( Site 1215)

    Paris, 75014

    Study Coordinator, 33 1 44 12 33 33

    Recruiting

  • Hôpital Européen Georges Pompidou ( Site 1214)

    Paris, 75015

    Study Coordinator, +33156093473

    Recruiting

  • Centre Hospitalier de Pau ( Site 1217)

    Pau, Pyrenees-Atlantiques, 64000

    Study Coordinator, +33559924848

    Recruiting

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

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

    Study Coordinator, +33383157853

    Recruiting

Other trials in France

Malaysia8 sites, 8 recruiting

  • Hospital Pulau Pinang ( Site 3108)

    George Town, Pulau Pinang, 10990

    Study Coordinator, 04-2225503

    Recruiting

  • Sultan Ismail Hospital ( Site 3103)

    Johor Bahru, Johor, 81100

    Study Coordinator, 6073565000

    Recruiting

  • Hospital Wanita and Kanak Kanak Sabah ( Site 3110)

    Kota Kinabalu, Sabah, 88996

    Study Coordinator, +6088522600

    Recruiting

  • Cengild G.I. Medical Centre ( Site 3112)

    Kuala Lumpur, 592000

    Study Coordinator, +60128223310

    Recruiting

  • Hospital Tengku Ampuan Afzan ( Site 3109)

    Kuantan, Pahang, 25100

    Study Coordinator, +6095133333

    Recruiting

  • Sarawak General Hospital ( Site 3101)

    Kuching, Sarawak, 93586

    Study Coordinator, +6082276666

    Recruiting

  • Sunway Medical Centre ( Site 3106)

    Petaling Jaya, Selangor, 47500

    Study Coordinator, +60127810425

    Recruiting

  • University Malaya Medical Centre ( Site 3107)

    Wilayah Persekutuan, Kuala Lumpur, 59100

    Study Coordinator, +6012-3225311

    Recruiting

Other trials in Malaysia

Romania8 sites, 8 recruiting

  • SC ONCO CARD SRL ( Site 2109)

    Brasov, 500052

    Study Coordinator, +40 268960

    Recruiting

  • Spitalul Clinic Colțea ( Site 2102)

    Bucharest, Bucharest, 030171

    Study Coordinator, +40213874100

    Recruiting

  • SC MNT Healthcare Europe SRL ( Site 2105)

    Bucharest, 013975

    Study Coordinator, +40 31 630 0000

    Recruiting

  • Delta Health Care SRL ( Site 2108)

    Bucharest, 014142

    Study Coordinator, +40 21 9977

    Recruiting

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

    Cluj-Napoca, Cluj, 400015

    Study Coordinator, +40264598362

    Recruiting

  • Centrul de Oncologie "Sfântul Nectarie" ( Site 2107)

    Craiova, Dolj, 200347

    Study Coordinator, +40 731604432

    Recruiting

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

    Florești, Cluj, 407280

    Study Coordinator, +40219368

    Recruiting

  • Spitalul Municipal Schuller Ploiești ( Site 2106)

    Ploieşti, Prahova, 100337

    Study Coordinator, +40 244 544 444

    Recruiting

Other trials in Romania

Turkey (Türkiye)8 sites, 8 recruiting

  • Hacettepe Universite Hastaneleri ( Site 2400)

    Altindağ, Ankara, 06230

    Study Coordinator, +905308346044

    Recruiting

  • Gazi Universitesi Tip Fakultesi ( Site 2404)

    Ankara, 06560

    Study Coordinator, +905304416643

    Recruiting

  • Ankara Bilkent Sehir Hastanesi ( Site 2401)

    Ankara, 06800

    Study Coordinator, +905360550126

    Recruiting

  • Trakya Universitesi Tip Fakultesi ( Site 2406)

    Edirne, 22030

    Study Coordinator, +905334046866

    Recruiting

  • Bakirkoy Dr. Sadi Konuk Training and Research Hospital ( Site 2408)

    Istanbul, 34147

    Study Coordinator, +905458730893

    Recruiting

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2403)

    Istanbul, 34722

    Study Coordinator, +90 216 606 5200

    Recruiting

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2405)

    Istanbul, 34899

    Study Coordinator, +905053208875

    Recruiting

  • Adana Medical Park Seyhan Hastanesi ( Site 2407)

    Seyhan, Adana, 01140

    Study Coordinator, +905393275092

    Recruiting

Other trials in Turkey (Türkiye)

Mexico7 sites, 7 recruiting

  • Grupo Médico ASSET SC ( Site 0811)

    Benito Juárez, Mexico City, 03100

    Study Coordinator, +522223813254

    Recruiting

  • Scientia Investigacion Clinica S.C. ( Site 0804)

    Chihuahua City, 31207

    Study Coordinator, +52614189866

    Recruiting

  • CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 0801)

    Guadalajara, Jalisco, 44260

    Study Coordinator, +523316016549

    Recruiting

  • Instituto Nacional de Cancerologia. ( Site 0808)

    Mexico City, 14080

    Study Coordinator, +525513150894

    Recruiting

  • Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0800)

    Monterrey, Nuevo León, 64460

    Study Coordinator, +528183338111

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 0813)

    Oaxaca City, Oaxaca, 68020

    Study Coordinator, +52 9516 035 559

    Recruiting

  • Clinica Integral Internacional de Oncología ( Site 0812)

    Puebla City, 72530

    Study Coordinator, 2226883533

    Recruiting

Other trials in Mexico

Spain7 sites, 7 recruiting

  • Complejo Hospitalario Universitario A Coruna ( Site 2207)

    A Coruña, La Coruna, 15006

    Study Coordinator, +34981178000ext92872

    Recruiting

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

    Badalona, Catalonia, 08916

    Study Coordinator, +34934978387

    Recruiting

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 2201)

    Barcelona, Catalonia, 08036

    Study Coordinator, +34913368023

    Recruiting

  • Hospital Universitario Ramon y Cajal ( Site 2203)

    Madrid, 28034

    Study Coordinator, +34913368023

    Recruiting

  • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 2202)

    Majadahonda, Madrid, Comunidad de, 28222

    Study Coordinator, +34911916671

    Recruiting

  • Hospital Universitario Virgen de Valme ( Site 2205)

    Seville, 41014

    Study Coordinator, +34955015273

    Recruiting

  • Hospital General Universitario de Valencia ( Site 2204)

    Valencia, Valenciana, Comunitat, 46014

    Study Coordinator, +34 963187527

    Recruiting

Other trials in Spain

Ukraine7 sites, 7 recruiting

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

    Chernivtsi, Chernivetska Oblast, 58013

    Study Coordinator, 380443344770

    Recruiting

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

    Kyiv, 02000

    Study Coordinator, +380939720596

    Recruiting

  • Universal Clinic Oberig ( Site 2506)

    Kyiv, 03057

    Study Coordinator, +380445213003

    Recruiting

  • Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 2507)

    Lviv, Lviv Oblast, 79031

    Study Coordinator, +380505136507

    Recruiting

  • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2518)

    Odesa, Odesa Oblast, 65025

    Study Coordinator, +380972147211

    Recruiting

  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)

    Rivne, Rivne Oblast, 33010

    Study Coordinator, +38050 380 29 15

    Recruiting

  • Zhytomyr Regional Oncology Center ( Site 2519)

    Zhytomyr, Zhytomyr Oblast, 10002

    Study Coordinator, +380952269282

    Recruiting

Other trials in Ukraine

Greece6 sites, 6 recruiting

  • Errikos Dunant Hospital Center ( Site 1408)

    Athens, Attica, 115 26

    Study Coordinator, +302106972246

    Recruiting

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1409)

    Athens, Attica, 115 27

    Study Coordinator, +302107700220

    Recruiting

  • General Hospital of Athens "Laiko" ( Site 1402)

    Athens, Attica, 11526

    Study Coordinator, +302132060956

    Recruiting

  • Metropolitan General Hospital ( Site 1400)

    Athens, Attica, 155 62

    Study Coordinator, +302106502542

    Recruiting

  • Agios Andreas Hospital Patras ( Site 1407)

    Pátrai, Achaia, 263 35

    Study Coordinator, +302613601000

    Recruiting

  • Papageorgiou General Hospital of Thessaloniki ( Site 1403)

    Thessaloniki, 564 29

    Study Coordinator, +302313323959

    Recruiting

Other trials in Greece

South Korea6 sites, 6 recruiting

  • Pusan National University Hospital ( Site 3501)

    Busan, Pusan-Kwangyokshi, 49241

    Study Coordinator, +82512407889

    Recruiting

  • Chungnam National University Hospital ( Site 3503)

    Daejeon, Taejon-Kwangyokshi, 35015

    Study Coordinator, +82-42-280-8035

    Recruiting

  • Chonnam National University Hwasun Hospital ( Site 3502)

    Jeollanam-do, Jeonranamdo, 58128

    Study Coordinator, 82-61-379-7614

    Recruiting

  • Kyung Hee University Medical Center ( Site 3500)

    Seoul, 02447

    Study Coordinator, 8229588511

    Recruiting

  • Korea University Guro Hospital ( Site 3505)

    Seoul, 08308

    Study Coordinator, +82226261914

    Recruiting

  • Pusan National University Yangsan Hospital ( Site 3504)

    Yangsan, Kyongsangnam-do, 50612

    Study Coordinator, 8215777512

    Recruiting

Other trials in South Korea

Taiwan6 sites, 6 recruiting

  • Chang Gung Memorial Hospital- Chiayi ( Site 3611)

    Chiayi City, Chiayi, 613

    Study Coordinator, +88653621000

    Recruiting

  • Taipei Medical University Shuang Ho Hospital ( Site 3602)

    New Taipei City, 235

    Study Coordinator, +886970746943

    Recruiting

  • National Cheng Kung University Hospital ( Site 3604)

    Tainan, 704

    Study Coordinator, +88662353535x3120

    Recruiting

  • MacKay Memorial Hospital ( Site 3609)

    Taipei, 10449

    Study Coordinator, +886225433535

    Recruiting

  • National Taiwan University Cancer Center (NTUCC) ( Site 3601)

    Taipei, 106

    Study Coordinator, +88623123456ex67511

    Recruiting

  • Tri-Service General Hospital ( Site 3603)

    Taipei, 114

    Study Coordinator, +886287923311x13899

    Recruiting

Other trials in Taiwan

Australia5 sites, 5 recruiting

  • The Prince Charles Hospital ( Site 2903)

    Brisbane, Queensland, 4032

    Study Coordinator, +61731394000

    Recruiting

  • Genesis Care- Campbelltown ( Site 2907)

    Campbelltown, New South Wales, 2560

    Study Coordinator, +610246325500

    Recruiting

  • Peninsula & South Eastern Haematology and Oncology Group ( Site 2908)

    Frankston, Victoria, 3199

    Study Coordinator, +61397815244

    Recruiting

  • Northern Beaches Hospital ( Site 2905)

    Frenchs Forest, New South Wales, 2086

    Study Coordinator, +61291055000

    Recruiting

  • Mater Hospital Brisbane ( Site 2906)

    South Brisbane, Queensland, 4101

    Study Coordinator, +61731631369

    Recruiting

Other trials in Australia

Israel5 sites, 5 recruiting

  • Yitzhak Shamir Medical Center. ( Site 1709)

    Beer Ya Akov, 7033001

    Study Coordinator, +97289542196

    Recruiting

  • Shaare Zedek Medical Center ( Site 1706)

    Jerusalem, 9103102

    Study Coordinator, +97226555999

    Recruiting

  • Meir Medical Center. ( Site 1702)

    Kfar Saba, 4428164

    Study Coordinator, +97297472555

    Recruiting

  • Sheba Medical Center ( Site 1700)

    Ramat Gan, 5265601

    Study Coordinator, +97235303030

    Recruiting

  • Sourasky Medical Center ( Site 1705)

    Tel Aviv, 6423906

    Study Coordinator, 97236974444

    Recruiting

Other trials in Israel

Argentina4 sites, 4 recruiting

  • Instituto Alexander Fleming ( Site 0311)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

    Study Coordinator, +5491166936669

    Recruiting

  • Hospital Italiano de Cordoba ( Site 0308)

    Córdoba, 5000

    Study Coordinator, +543514106550

    Recruiting

  • CEMAIC ( Site 0309)

    Córdoba, X5008AAC

    Study Coordinator, +543513976568

    Recruiting

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, +542234963224

    Recruiting

Other trials in Argentina

Belgium4 sites, 4 recruiting

  • Algemeen Ziekenhuis Klina ( Site 3904)

    Brasschaat, Antwerpen, 2930

    Study Coordinator, 003236505158

    Recruiting

  • Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903)

    Genk, Limburg, 3600

    Study Coordinator, +3289804028

    Recruiting

  • Clinical Chc Montlégia ( Site 3901)

    Liège, 4000

    Study Coordinator, +3243554107

    Recruiting

  • VITAZ ( Site 3902)

    Sint-Niklaas, Oost-Vlaanderen, 9100

    Study Coordinator, 003237602327

    Recruiting

Other trials in Belgium

Netherlands4 sites, 4 recruiting

  • Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1907)

    Breda, North Brabant, 4818 CK

    Study Coordinator, +31765955000

    Recruiting

  • University Medical Center Groningen ( Site 1908)

    Groningen, 9713 GZ

    Study Coordinator, +31503616161

    Recruiting

  • Elisabeth-TweeSteden Ziekenhuis ( Site 1906)

    Tilburg, North Holland, 5022 GC

    Study Coordinator, +31132210000

    Recruiting

  • Universitair Medisch Centrum Utrecht ( Site 1901)

    Utrecht, 3584 CX

    Study Coordinator, +31 88 755 5555

    Recruiting

Other trials in Netherlands

United Kingdom4 sites, 4 recruiting

  • Queen Elizabeth Hospital Birmingham ( Site 2612)

    Birmingham, B15 2TH

    Study Coordinator, +441213712000

    Recruiting

  • Leicester Royal Infirmary ( Site 2610)

    Leicester, LE1 5WW

    Study Coordinator, +4401162587605

    Recruiting

  • Royal Free Hospital ( Site 2601)

    London, London, City of, NW3 2QG

    Study Coordinator, +44207794 050031911

    Recruiting

  • Royal Cornwall Hospital ( Site 2614)

    Truro, Cornwall, TR1 2LJ

    Study Coordinator, +441872 258343

    Recruiting

Other trials in United Kingdom

Austria3 sites, 3 recruiting

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

    Graz, Styria, 8036

    Study Coordinator, +4331638578055

    Recruiting

  • Klinikum Klagenfurt am Wörthersee ( Site 1002)

    Klagenfurt, Carinthia, 9020

    Study Coordinator, +434635380

    Recruiting

  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001)

    Vienna, 1210

    Study Coordinator, +43 1 27700 3855

    Recruiting

Other trials in Austria

Chile3 sites, 3 recruiting

  • Centro de Estudios Clínicos SAGA ( Site 0503)

    Santiago, Region M. de Santiago, 7500653

    Study Coordinator, +56990556961

    Recruiting

  • Fundación Arturo López Pérez ( Site 0500)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224457254

    Recruiting

  • Bradfordhill ( Site 0501)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

Other trials in Chile

Colombia3 sites, 3 recruiting

  • Hospital Universitario San Ignacio ( Site 0604)

    Bogotá, Bogota D.C., 110231

    Study Coordinator, +576015946161

    Recruiting

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607)

    Bogotá, Bogota D.C., 111321

    Study Coordinator, +573016254437

    Recruiting

  • Promotora Médica Las Américas S.A. ( Site 0608)

    Medellín, Antioquia, 050025

    Study Coordinator, +570343421010

    Recruiting

Other trials in Colombia

Guatemala3 sites, 2 recruiting

  • MEDI-K ( Site 3803)

    Guatemala City, 01009

    Active, not recruiting

  • Centro Integral De Oncologia Gastrointestinal Y Hemato-Oncologia De Guatemala, S. A ( Site 3802)

    Guatemala City, 01010

    Study Coordinator, +50222545639

    Recruiting

  • Servicios Médicos Oncológicos ( Site 3804)

    Guatemala City, 1010

    Study Coordinator, +50222830436

    Recruiting

Other trials in Guatemala

Hungary3 sites, 3 recruiting

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)

    Budapest, Pest County, 1121

    Study Coordinator, +36 1 391 3200

    Recruiting

  • Nograd Varmegyei Szent Lazar Korhaz ( Site 1509)

    Salgótarján, Nógrád megye, 3100

    Study Coordinator, +36 32 522 000

    Recruiting

  • Reformatus Pulmonologiai Centrum ( Site 1503)

    Törökbálint, Pest County, 2045

    Study Coordinator, +36307005601

    Recruiting

Other trials in Hungary

Peru3 sites, 3 recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0902)

    Lima, 15036

    Study Coordinator, +51 997345775

    Recruiting

  • Oncosalud ( Site 0901)

    Lima, 15036

    Study Coordinator, +51957511783

    Recruiting

  • Hospital Nacional Edgardo Rebagliati Martins ( Site 0903)

    Lima, 15072

    Study Coordinator, +5112654901

    Recruiting

Other trials in Peru

Poland3 sites, 3 recruiting

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2012)

    Gliwice, Silesian Voivodeship, 44-102

    Study Coordinator, +48322789791

    Recruiting

  • Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2004)

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

    Study Coordinator, +48895322978

    Recruiting

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2008)

    Przemyśl, Podkarpackie Voivodeship, 37-700

    Study Coordinator, +48166775000

    Recruiting

Other trials in Poland

Canada2 sites, 2 recruiting

  • Cross Cancer Institute ( Site 0203)

    Edmonton, Alberta, T6G 1Z2

    Study Coordinator, 7804328248

    Recruiting

  • Sunnybrook Research Institute ( Site 0209)

    Toronto, Ontario, M4N 3M5

    Study Coordinator, 416-480-5248

    Recruiting

Other trials in Canada

Switzerland2 sites, 2 recruiting

  • Klinik fur Hamatologie und Onkologie Hirslanden Zurich ( Site 4001)

    Zurich, 8032

    Study Coordinator, +4144 3873780

    Recruiting

  • Stadtspital Zürich Triemli - Klinik für Medizinische Onkologie und Hämatologie ( Site 4000)

    Zurich, 8063

    Study Coordinator, +41444163520

    Recruiting

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

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.

Being tested
Calderasib, Pembrolizumab (+) Berahyaluronidase alfa, Pemetrexed, Cisplatin, Carboplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CalderasibDrug

    Also called MK-1084

    Administered as an oral tablet

  • Pembrolizumab (+) Berahyaluronidase alfaBiological

    Also called MK-3475A

    Administered as a SC injection

  • PemetrexedDrug

    Also called Alimta

    Administered as an IV Infusion

  • CisplatinDrug

    Also called Platinol-AQ

    Administered as an IV Infusion

  • CarboplatinDrug

    Also called PARAPLATIN®

    Administered as an IV Infusion

Study groups in NCT07190248
Study groupRoleWhat they receive
Calderasib + Pembrolizumab (+) Berahyaluronidase alfaExperimentalParticipants 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.
Receives: Drug: Calderasib; Biological: Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa + ChemotherapyActive comparatorParticipants 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).
Receives: Biological: Pembrolizumab (+) Berahyaluronidase alfa; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

    PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.

    Measured: Up to approximately 48 months

Secondary outcomes (16)

  1. PFS in All Participants

    PFS is defined as the time from randomization until either documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS as determined by BICR will be presented.

    Measured: Up to approximately 48 months

  2. Overall Survival (OS) in Participants with PD-L1 TPS ≥1%

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 62 months

  3. OS in Participants in All Participants

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 62 months

  4. Overall Response Rate (ORR) in All Participants

    ORR is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) per RECIST1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 48 months

  5. ORR in Participants with PD-L1 TPS ≥1%

    ORR is defined as the percentage of participants with CR or PR per RECIST1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 48 months

  6. Duration of Response (DOR)

    For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 48 months

  7. Number of Participants Who Experienced One or More Adverse Events (AEs)

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented.

    Measured: Up to approximately 81 months

  8. Number of Participants Who Discontinued Study Treatment Due to an AE

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented.

    Measured: Up to approximately 81 months

  9. Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) (Items 29, 30) on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. Higher scores indicate a better overall health status.

    Measured: Baseline and up to approximately 81 months

  10. Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. A higher score indicates a worse level of dyspnea.

    Measured: Baseline and up to approximately 81 months

  11. Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13)

    The EORTC QLQ-C13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. A higher score indicates more frequent coughing.

    Measured: Baseline and up to approximately 81 months

  12. Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

    The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 40 will be presented. A higher score indicates a worse level of chest pain.

    Measured: Baseline and up to approximately 81 months

  13. Time to Deterioration (TTD) in GHS/QoL (Items 29, 30) on the EORTC QLQ-C30

    TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in global health status (GHS) and quality of life (QoL) (EORTC QLQ-C30 Items 29 and 30) score. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in GHS and QoL, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 81 months

  14. TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in dyspnea (EORTC QLQ-C30 Item 8) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in dyspnea score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 81 months

  15. TTD in Cough Score (Item 31) on the EORTC QLQ-LC13

    TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in cough (EORTC QLQ-C13 Item 31) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in cough score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 81 months

  16. TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

    TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in chest pain (EORTC QLQ-C13 Item 40) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline chest pain score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 81 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start8 Oct 2025
  3. Primary completion7 Dec 2029 (estimated)
  4. Study completion6 Aug 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
675 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07190248
Sponsor's protocol ID
1084-007
Other IDs
U1111-1307-9569, 2024-514500-14-00, MK-1084-007, KANDLELIT-007, jRCT2031240722
Status last verified
Oct 2026
First submitted
16 Sep 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calderasib, Pembrolizumab (+) Berahyaluronidase alfa and Pemetrexed in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 221 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 221 sites in China, Japan, United States, Italy, Brazil and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% (time frame: Up to approximately 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07190248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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