Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07190248

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

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-11

675

Participants Needed

153

Research Sites

356 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
  • If HIV positive, must have well controlled HIV on antiretroviral therapy (ART)
Not Eligible

You will not qualify if you...

  • Has diagnosis of small cell lung cancer or presence of small cell elements in mixed tumors
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
  • Has uncontrolled, significant cardiovascular or cerebrovascular disease
  • Has a gastrointestinal disorder affecting absorption
  • Is HIV positive with history of Kaposi's sarcoma or Multicentric Castleman's Disease
  • Has received prior systemic anticancer therapy for advanced or metastatic NSCLC
  • Has known additional malignancy progressing or treated within past 3 years
  • Has known active central nervous system metastases or carcinomatous meningitis
  • Has active autoimmune disease requiring systemic treatment in past 2 years
  • Has history or current pneumonitis/interstitial lung disease requiring steroids
  • Has active infection requiring systemic therapy except those specified by protocol
  • Has history of stem cell or solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 153 locations

1

Central Alabama Research ( Site 0108)

Birmingham, Alabama, United States, 35209

Actively Recruiting

2

Stamford Hospital ( Site 0126)

Stamford, Connecticut, United States, 06902

Actively Recruiting

3

Mount Sinai Cancer Center ( Site 0137)

Miami Beach, Florida, United States, 33140

Completed

4

Indiana University Health Arnett Cancer Center ( Site 0116)

Lafayette, Indiana, United States, 47904

Actively Recruiting

5

New England Cancer Specialists ( Site 0139)

Westbrook, Maine, United States, 04092

Actively Recruiting

6

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

Albany, New York, United States, 12206

Actively Recruiting

7

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

Lancaster, Pennsylvania, United States, 17601

Actively Recruiting

8

Blue Ridge Cancer Care ( Site 0144)

Roanoke, Virginia, United States, 24014

Actively Recruiting

9

Instituto Alexander Fleming ( Site 0311)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ

Actively Recruiting

10

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)

Mar del Plata, Buenos Aires, Argentina, B7600FZO

Actively Recruiting

11

Hospital Italiano de Cordoba ( Site 0308)

Córdoba, Argentina, 5000

Actively Recruiting

12

CEMAIC ( Site 0309)

Córdoba, Argentina, X5008AAC

Actively Recruiting

13

Genesis Care- Campbelltown ( Site 2907)

Campbelltown, New South Wales, Australia, 2560

Actively Recruiting

14

Northern Beaches Hospital ( Site 2905)

Frenchs Forest, New South Wales, Australia, 2086

Actively Recruiting

15

The Prince Charles Hospital ( Site 2903)

Brisbane, Queensland, Australia, 4032

Actively Recruiting

16

Mater Hospital Brisbane ( Site 2906)

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

17

Klinikum Klagenfurt am Wörthersee ( Site 1002)

Klagenfurt, Carinthia, Austria, 9020

Actively Recruiting

18

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

Graz, Styria, Austria, 8036

Actively Recruiting

19

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

Vienna, Austria, 1210

Actively Recruiting

20

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

Genk, Limburg, Belgium, 3600

Actively Recruiting

21

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412)

Fortaleza, Ceará, Brazil, 60336-232

Actively Recruiting

22

Hospital Santa Rita de Cassia ( Site 0403)

Vitória, Espírito Santo, Brazil, 29043-260

Actively Recruiting

23

Real Hospital Portugues ( Site 0418)

Recife, Pernambuco, Brazil, 52010075

Actively Recruiting

24

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

Porto Alegre, Rio Grande do Sul, Brazil, 90110-270

Actively Recruiting

25

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

Florianópolis, Santa Catarina, Brazil, 88020-210

Actively Recruiting

26

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

Ribeirão Preto, São Paulo, Brazil, 14048-900

Actively Recruiting

27

Faculdade de Medicina do ABC ( Site 0411)

Santo André, São Paulo, Brazil, 09060-870

Actively Recruiting

28

Hospital Alemao Oswaldo Cruz ( Site 0413)

São Paulo, São Paulo, Brazil, 01327-001

Actively Recruiting

29

IBCC - Núcleo de Pesquisa e Ensino ( Site 0417)

São Paulo, Brazil, 04014-002

Actively Recruiting

30

Centro de Estudios Clínicos SAGA ( Site 0503)

Santiago, Region M. de Santiago, Chile, 7500653

Actively Recruiting

31

FALP ( Site 0500)

Santiago, Region M. de Santiago, Chile, 7500921

Actively Recruiting

32

Bradfordhill ( Site 0501)

Santiago, Region M. de Santiago, Chile, 8420383

Actively Recruiting

33

Anhui Provincial Cancer Hospital ( Site 2708)

Hefei, Anhui, China, 230031

Actively Recruiting

34

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

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

35

Beijing Peking Union Medical College Hospital ( Site 2702)

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

36

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

Fujian, Fujian, China, 350005

Actively Recruiting

37

Fujian Provincial Cancer Hospital ( Site 2706)

Fuzhou, Fujian, China, 350014

Actively Recruiting

38

The First Affiliated Hospital of Xiamen University ( Site 2717)

Fuzhou, Fujian, China, 361003

Actively Recruiting

39

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

Guangzhou, Guangdong, China, 510080

Actively Recruiting

40

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

Guangzhou, Guangdong, China, 510095

Actively Recruiting

41

Zhujiang Hospital of Southern Medical University ( Site 2744)

Guangzhou, Guangdong, China, 510280

Actively Recruiting

42

Affiliated Cancer Hospital of Guangxi Medical University ( Site 2704)

Nanning, Guangxi, China, 530021

Actively Recruiting

43

JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 2745)

Jiamusi, Heilongjiang, China, 154007

Actively Recruiting

44

Henan Cancer Hospital ( Site 2746)

Zhengzhou, Henan, China, 450008

Actively Recruiting

45

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

Wuhan, Hubei, China, 430030

Actively Recruiting

46

Hubei Cancer Hospital ( Site 2721)

Wuhan, Hubei, China, 430079

Actively Recruiting

47

Xiangya Hospital Central South University ( Site 2741)

Changsha, Hunan, China, 410008

Actively Recruiting

48

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

Nanjing, Jiangsu, China, 210000

Active, Not Recruiting

49

Jiangxi Cancer Hospital ( Site 2725)

Nanchang, Jiangxi, China, 330029

Actively Recruiting

50

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

Xi'an, Shaanxi, China, 710061

Actively Recruiting

51

LinYi Cancer Hospital ( Site 2737)

Linyi, Shandong, China, 276000

Actively Recruiting

52

Shanghai Pulmonary Hospital-Oncology Department ( Site 2723)

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

53

Shanxi Cancer Hospital ( Site 2728)

Taiyuan, Shanxi, China, 030013

Actively Recruiting

54

Sichuan Cancer Hospital. ( Site 2739)

Chengdu, Sichuan, China, 610213

Actively Recruiting

55

West China Hospital Sichuan University ( Site 2735)

Chengdu, Sichuan, China, 611135

Actively Recruiting

56

Chongqing University Cancer Hospital ( Site 2736)

Chongqing, Sichuan, China, 400030

Actively Recruiting

57

Yunnan Province Cancer Hospital ( Site 2734)

Kunming, Yunnan, China, 650118

Actively Recruiting

58

The First Affiliated Hospital, Zhejiang University ( Site 2716)

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

59

Sir Run Run Shaw Hospital ( Site 2731)

Hangzhou, Zhejiang, China, 310015

Actively Recruiting

60

Zhejiang Cancer Hospital ( Site 2727)

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

61

Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2724)

Taizhou, Zhejiang, China, 317000

Actively Recruiting

62

Hopital Europeen Marseille ( Site 1207)

Marseille, Bouches-du-Rhone, France, 13003

Actively Recruiting

63

CHU Caen ( Site 1212)

Caen, Calvados, France, 14000

Actively Recruiting

64

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

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

Actively Recruiting

65

Centre Hospitalier Metropole Savoie Site de Chambery ( Site 1208)

Chambéry, Savoie, France, 73011

Actively Recruiting

66

Clinique de l'Europe ( Site 1213)

Amiens, Somme, France, 80000

Actively Recruiting

67

Groupe Hospitalier Paris Saint Joseph ( Site 1215)

Paris, France, 75014

Actively Recruiting

68

Hôpital Européen Georges Pompidou ( Site 1214)

Paris, France, 75015

Actively Recruiting

69

Agios Andreas Hospital Patras ( Site 1407)

Pátrai, Achaia, Greece, 263 35

Actively Recruiting

70

Errikos Dunant Hospital Center ( Site 1408)

Athens, Attica, Greece, 115 26

Actively Recruiting

71

General Hospital of Athens "Laiko" ( Site 1402)

Athens, Attica, Greece, 11526

Actively Recruiting

72

Metropolitan General Hospital ( Site 1400)

Athens, Attica, Greece, 155 62

Actively Recruiting

73

Papageorgiou General Hospital of Thessaloniki ( Site 1403)

Thessaloniki, Greece, 564 29

Actively Recruiting

74

Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)

Budapest, Pest County, Hungary, 1121

Actively Recruiting

75

Reformatus Pulmonologiai Centrum ( Site 1503)

Törökbálint, Pest County, Hungary, 2045

Actively Recruiting

76

Yitzhak Shamir Medical Center. ( Site 1709)

Beer Ya Akov, Israel, 7033001

Actively Recruiting

77

Shaare Zedek Medical Center ( Site 1706)

Jerusalem, Israel, 9103102

Actively Recruiting

78

Meir Medical Center. ( Site 1702)

Kfar Saba, Israel, 4428164

Actively Recruiting

79

Sheba Medical Center ( Site 1700)

Ramat Gan, Israel, 5265601

Actively Recruiting

80

Sourasky Medical Center ( Site 1705)

Tel Aviv, Israel, 6423906

Actively Recruiting

81

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

Meldola, Forli-Cesena, Italy, 47014

Actively Recruiting

82

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1811)

Bergamo, Lombardy, Italy, 24127

Actively Recruiting

83

Istituto Clinico Humanitas ( Site 1812)

Rozzano, Milano, Italy, 20089

Actively Recruiting

84

Ospedale San Giuseppe Moscati ( Site 1816)

Statte, Taranto, Italy, 74010

Actively Recruiting

85

AOU Careggi ( Site 1801)

Florence, Tuscany, Italy, 50134

Actively Recruiting

86

AOU Renato Dulbecco ( Site 1804)

Catanzaro, Italy, 88100

Actively Recruiting

87

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

Naples, Italy, 80131

Actively Recruiting

88

Policlinico San Matteo ( Site 1802)

Pavia, Italy, 27100

Actively Recruiting

89

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

Verona, Italy, 37126

Actively Recruiting

90

Aichi Cancer Center ( Site 2813)

Nagoya, Aichi-ken, Japan, 464-8681

Actively Recruiting

91

Fujita Health University Hospital ( Site 2807)

Toyoake, Aichi-ken, Japan, 470-1192

Actively Recruiting

92

Hirosaki University Hospital ( Site 2818)

Hirosaki, Aomori, Japan, 036-8563

Actively Recruiting

93

National Hospital Organization Himeji Medical Center ( Site 2827)

Himeji, Hyōgo, Japan, 670-8520

Actively Recruiting

94

Kobe City Medical Center General Hospital ( Site 2811)

Kobe, Hyōgo, Japan, 650-0047

Actively Recruiting

95

Takarazuka City Hospital ( Site 2828)

Takarazuka, Hyōgo, Japan, 665-0827

Actively Recruiting

96

Yokohama Municipal Citizen's Hospital ( Site 2824)

Yokohama, Kanagawa, Japan, 221-0855

Actively Recruiting

97

Kanagawa Cancer Center ( Site 2820)

Yokohama, Kanagawa, Japan, 241-8515

Actively Recruiting

98

Saiseikai Matsusaka Municipal Hospital ( Site 2808)

Matsusaka, Mie-ken, Japan, 515-8544

Actively Recruiting

99

Tohoku University Hospital ( Site 2804)

Sendai, Miyagi, Japan, 980-8574

Actively Recruiting

100

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

Sakai, Osaka, Japan, 591-8555

Actively Recruiting

101

Osaka Medical and Pharmaceutical University Hospital ( Site 2810)

Takatsuki, Osaka, Japan, 569-8686

Actively Recruiting

102

National Hospital Organization Ureshino Medical Center ( Site 2817)

Ureshino, Saga-ken, Japan, 843-0393

Actively Recruiting

103

Nippon Medical School Hospital ( Site 2819)

Bunkyo, Tokyo, Japan, 113-8603

Actively Recruiting

104

Tokyo Medical University Hospital ( Site 2829)

Shinjuku, Tokyo, Japan, 160-0023

Actively Recruiting

105

National Center for Global Health and Medicine ( Site 2806)

Shinjuku, Tokyo, Japan, 162-8655

Actively Recruiting

106

Chiba University Hospital ( Site 2812)

Chiba, Japan, 260-8677

Actively Recruiting

107

National Hospital Organization Kyushu Medical Center ( Site 2801)

Fukuoka, Japan, 810-8563

Actively Recruiting

108

Hiroshima City Hiroshima Citizens Hospital ( Site 2821)

Hiroshima, Japan, 730-8518

Actively Recruiting

109

Saiseikai Kumamoto Hospital ( Site 2816)

Kumamoto, Japan, 861-4193

Actively Recruiting

110

Osaka Metropolitan University Hospital ( Site 2826)

Osaka, Japan, 545-8586

Actively Recruiting

111

Hospital Tengku Ampuan Afzan ( Site 3109)

Kuantan, Pahang, Malaysia, 25100

Actively Recruiting

112

Hospital Pulau Pinang ( Site 3108)

George Town, Pulau Pinang, Malaysia, 10990

Actively Recruiting

113

Hospital Wanita and Kanak Kanak Sabah ( Site 3110)

Kota Kinabalu, Sabah, Malaysia, 88996

Actively Recruiting

114

Sarawak General Hospital ( Site 3101)

Kuching, Sarawak, Malaysia, 93586

Actively Recruiting

115

Sunway Medical Centre ( Site 3106)

Petaling Jaya, Selangor, Malaysia, 47500

Actively Recruiting

116

Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1907)

Breda, North Brabant, Netherlands, 4818 CK

Actively Recruiting

117

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

Przemyśl, Podkarpackie Voivodeship, Poland, 37-700

Actively Recruiting

118

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2012)

Gliwice, Silesian Voivodeship, Poland, 44-102

Actively Recruiting

119

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

Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-357

Actively Recruiting

120

Spitalul Clinic Colțea ( Site 2102)

Bucharest, Bucharest, Romania, 030171

Actively Recruiting

121

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

Cluj-Napoca, Cluj, Romania, 400015

Actively Recruiting

122

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

Florești, Cluj, Romania, 407280

Actively Recruiting

123

Centrul de Oncologie "Sfântul Nectarie" ( Site 2107)

Craiova, Dolj, Romania, 200347

Actively Recruiting

124

Spitalul Municipal Schuller Ploiești ( Site 2106)

Ploieşti, Prahova, Romania, 100337

Actively Recruiting

125

SC ONCO CARD SRL ( Site 2109)

Brasov, Romania, 500052

Actively Recruiting

126

SC MNT Healthcare Europe SRL ( Site 2105)

Bucharest, Romania, 013975

Actively Recruiting

127

Delta Health Care SRL ( Site 2108)

Bucharest, Romania, 014142

Actively Recruiting

128

Chonnam National University Hwasun Hospital ( Site 3502)

Jeollanam-do, Jeonranamdo, South Korea, 58128

Actively Recruiting

129

Pusan National University Yangsan Hospital ( Site 3504)

Yangsan, Kyongsangnam-do, South Korea, 50612

Actively Recruiting

130

Pusan National University Hospital ( Site 3501)

Busan, Pusan-Kwangyokshi, South Korea, 49241

Actively Recruiting

131

Chungnam National University Hospital ( Site 3503)

Daejeon, Taejon-Kwangyokshi, South Korea, 35015

Actively Recruiting

132

Kyung Hee University Medical Center ( Site 3500)

Seoul, South Korea, 02447

Actively Recruiting

133

Korea University Guro Hospital ( Site 3505)

Seoul, South Korea, 08308

Actively Recruiting

134

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

Badalona, Catalonia, Spain, 08916

Actively Recruiting

135

HOSPITAL CLÍNIC DE BARCELONA ( Site 2201)

Barcelona, Catalonia, Spain, 08036

Actively Recruiting

136

Complejo Hospitalario Universitario A Coruna ( Site 2207)

A Coruña, La Coruna, Spain, 15006

Actively Recruiting

137

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 2202)

Majadahonda, Madrid, Comunidad de, Spain, 28220

Actively Recruiting

138

Hospital General Universitario de Valencia ( Site 2204)

Valencia, Valenciana, Comunitat, Spain, 46014

Actively Recruiting

139

Hospital Universitario Ramon y Cajal ( Site 2203)

Madrid, Spain, 28034

Actively Recruiting

140

Hospital Universitario Virgen de Valme ( Site 2205)

Seville, Spain, 41014

Actively Recruiting

141

Chang Gung Memorial Hospital- Chiayi ( Site 3611)

Chiayi City, Chiayi, Taiwan, 613

Actively Recruiting

142

Taipei Medical University Shuang Ho Hospital ( Site 3602)

New Taipei City, Taiwan, 235

Actively Recruiting

143

National Cheng Kung University Hospital ( Site 3604)

Tainan, Taiwan, 704

Actively Recruiting

144

MacKay Memorial Hospital ( Site 3609)

Taipei, Taiwan, 10449

Actively Recruiting

145

Tri-Service General Hospital ( Site 3603)

Taipei, Taiwan, 114

Actively Recruiting

146

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

Chernivtsi, Chernivetska Oblast, Ukraine, 58013

Actively Recruiting

147

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

Lviv, Lviv Oblast, Ukraine, 79031

Actively Recruiting

148

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)

Rivne, Rivne Oblast, Ukraine, 33010

Actively Recruiting

149

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

Kyiv, Ukraine, 02000

Actively Recruiting

150

Universal Clinic Oberig ( Site 2506)

Kyiv, Ukraine, 03057

Actively Recruiting

151

Royal Cornwall Hospital ( Site 2614)

Truro, Cornwall, United Kingdom, TR1 2LJ

Actively Recruiting

152

Royal Free Hospital ( Site 2601)

London, London, City of, United Kingdom, NW3 2QG

Actively Recruiting

153

Leicester Royal Infirmary ( Site 2610)

Leicester, United Kingdom, LE1 5WW

Actively Recruiting

Loading map...

Research Team

T

Toll Free Number

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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