A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Pembrolizumab; Drug: Sotorasib

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1426
    • Recruiting
    • Centro Oncologico Korben
  • La Rioja, Argentina, F5300COE
    • Recruiting
    • Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
  • Salta, Argentina, 4400
    • Recruiting
    • Centro de Diagnostico Investigacion y Tratamiento
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1280AEB
      • Recruiting
      • Hospital Británico de Buenos Aires
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
      • Recruiting
      • Instituto Argentino de Diagnostico y Tratamiento IADT
  • Jujuy
    • San Salvador de Jujuy, Jujuy, Argentina, 4600
      • Recruiting
      • Fundacion Ars Medica
  • Río Negro
    • Viedma, Río Negro, Argentina, 8500
      • Recruiting
      • Clinica Viedma
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Recruiting
      • Concord Repatriation General Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Recruiting
      • GenesisCare -North Shore Oncology
  • Queensland
    • Toowoomba, Queensland, Australia, 4350
      • Recruiting
      • Toowoomba Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Cancer Research South Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter Maccallum Cancer Centre
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred Hospital
• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medizinische Universitaet Graz
  • Klagenfurt, Austria, 9020
    • Recruiting
    • Klinikum Klagenfurt Am Woerthersee
  • Krems, Austria, 3500
    • Recruiting
    • Universitaetsklinikum Krems
  • Salzburg, Austria, 5020
    • Recruiting
    • Landeskrankenhaus Salzburg
• Belgium
  • Auderghem, Belgium, 1160
    • Recruiting
    • Chirec - Delta Ziekenhuis
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
  • Liège, Belgium, 4000
    • Recruiting
    • Centre Hospitalier Régional de la Citadelle
• Brazil
  • São Paulo, Brazil, 01246-000
    • Recruiting
    • Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Recruiting
      • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
• Bulgaria
  • Panagyurishte, Bulgaria, 4500
    • Recruiting
    • Multiprofile Hospital for Active Treatment - Uni Hospital OOD
  • Sofia, Bulgaria, 1527
    • Recruiting
    • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Recruiting
      • Nova Scotia Health Authority, Queen Elizabeth II, Health Sciences Centre
• Chile
  • Santiago, Chile, 7500836
    • Recruiting
    • Fundacion Arturo Lopez Perez
  • Santiago, Chile, 7500713
    • Recruiting
    • Orlandi Oncologia
  • Santiago, Chile, 8330336
    • Recruiting
    • Biocinetic
  • Cautín
    • Temuco, Cautín, Chile, 4810218
      • Recruiting
      • Clinica CIDO
• Czechia
  • Plzen, Czechia, 305 99
    • Recruiting
    • Fakultni nemocnice Plzen
• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Aarhus Universitetshospital
  • Herning, Denmark, 7400
    • Recruiting
    • Regionshospitalet Godstrup
  • Kobenhavn, Denmark, 2100
    • Recruiting
    • Rigshospitalet
  • Sonderborg, Denmark, 6400
    • Recruiting
    • Sonderborg Sygehus
• France
  • Besancon cedex, France, 25030
    • Recruiting
    • Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
  • Boulogne-Billancourt, France, 92104
    • Recruiting
    • Centre Hospitalier Universitaire Ambroise Pare
  • Créteil, France, 94010
    • Recruiting
    • Centre Hospitalier Intercommunal de Créteil
  • Le Mans, France, 72000
    • Recruiting
    • Centre Hospitalier - Le Mans
  • Lille Cedex, France, 59037
    • Recruiting
    • Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
  • Marseille Cedex 20, France, 13915
    • Recruiting
    • Centre Hospitalier Universitaire Nord
  • Montpellier, France, 34070
    • Recruiting
    • Centre de Cancerologie du Grand Montpellier-Clinique Clementville
  • Nimes cedex 9, France, 30029
    • Recruiting
    • Hôpital Universitaire Carémeau
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
  • Paris Cedex 20, France, 75020
    • Recruiting
    • Hôpital Tenon
  • Pessac Cedex, France, 33604
    • Recruiting
    • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
  • Poitiers Cedex, France, 86021
    • Recruiting
    • Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
  • Quimper, France, 29000
    • Recruiting
    • Centre Hospitalier de Cornouaille
  • Reims Cedex, France, 51092
    • Recruiting
    • Centre Hospitalier Universitaire de Reims - Hôpital Maison blanche
  • Toulon, France, 83800
    • Recruiting
    • Hopital d instruction des armees sainte anne
  • Toulouse Cedex 9, France, 31059
    • Recruiting
    • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
  • Tours Cedex 9, France, 37044
    • Recruiting
    • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
  • Villefranche Sur Saone Cedex, France, 69400
    • Recruiting
    • Hopital Nord-Ouest Villefranche
• Germany
  • Chemnitz, Germany, 09113
    • Recruiting
    • Klinikum Chemnitz GmbH
  • Goettingen, Germany, 37075
    • Recruiting
    • Universitaetsmedizin Goettingen
  • Kempten, Germany, 87439
    • Recruiting
    • Klinikverbund Allgaeu
• Greece
  • Athens, Greece, 18547
    • Recruiting
    • Metropolitan Hospital
  • Athens, Greece, 11526
    • Recruiting
    • Henry Dunant Hospital Center
  • Athens, Greece, 12462
    • Recruiting
    • Attikon University Hospital
  • Athens, Greece, 11525
    • Recruiting
    • 251 General Airforce Hospital
  • Athens, Greece, 11528
    • Recruiting
    • Alexandra Hospital
  • Marousi, Greece, 15123
    • Recruiting
    • Iaso General Clinic
  • Thessaloniki, Greece, 57001
    • Recruiting
    • European Interbalkan Medical Center
  • Thessaloniki, Greece, 55236
    • Recruiting
    • Agios Loukas Clinic
  • Thessaloniki, Greece, 54007
    • Recruiting
    • Theagenion Cancer Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • University of Hong Kong, Queen Mary Hospital
• Hungary
  • Budapest, Hungary, 1121
    • Recruiting
    • Orszagos Koranyi Pulmonologiai Intezet
  • Farkasgyepu, Hungary, 8582
    • Recruiting
    • Farkasgyepui Tudogyogyintezet
  • Gyongyos, Hungary, 3200
    • Recruiting
    • Matrai Gyogyintezet
  • Szekesfehervar, Hungary, 8000
    • Recruiting
    • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Tatabanya, Hungary, 2800
    • Recruiting
    • Komarom-Esztergom Varmegyei Szent Borbala Korhaz
  • Torokbalint, Hungary, 2045
    • Recruiting
    • Torokbalinti Tudogyogyintezet
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • IRCCS Istituto Tumori Giovanni Paolo II
  • Firenze, Italy, 50134
    • Recruiting
    • Azienda Ospedaliero Universitaria Careggi
  • Meldola (FC), Italy, 47014
    • Recruiting
    • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
  • Monza (MB), Italy, 20900
    • Recruiting
    • Fondazione IRCCS San Gerardo dei Tintori
  • Napoli, Italy, 80131
    • Recruiting
    • Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
  • Perugia, Italy, 06156
    • Recruiting
    • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 466-8560
      • Recruiting
      • Nagoya University Hospital
  • Aomori
    • Hirosaki-shi, Aomori, Japan, 036-8563
      • Recruiting
      • Hirosaki University Hospital
  • Chiba
    • Chiba-shi, Chiba, Japan, 260-8717
      • Recruiting
      • Chiba Cancer Center
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama-shi, Ehime, Japan, 791-0280
      • Recruiting
      • National Hospital Organization Shikoku Cancer Center
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 811-1395
      • Recruiting
      • National Hospital Organization Kyushu Cancer Center
    • Kitakyushu-shi, Fukuoka, Japan, 807-8556
      • Recruiting
      • Hospital of the University of Occupational and Environmental Health Japan
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Recruiting
      • Kurume University Hospital
  • Hiroshima
    • Fukuyama-shi, Hiroshima, Japan, 720-0001
      • Recruiting
      • Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 003-0804
      • Recruiting
      • National Hospital Organization Hokkaido Cancer Center
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0046
      • Recruiting
      • Kobe Minimally Invasive Cancer Center
    • Takarazuka-shi, Hyogo, Japan, 665-0827
      • Recruiting
      • Takarazuka City Hospital
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8641
      • Recruiting
      • Kanazawa University Hospital
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • Recruiting
      • St Marianna University Hospital
    • Yokohama-shi, Kanagawa, Japan, 241-8515
      • Recruiting
      • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
  • Miyagi
    • Natori-shi, Miyagi, Japan, 981-1293
      • Recruiting
      • Miyagi Cancer Center
    • Sendai-shi, Miyagi, Japan, 980-0873
      • Recruiting
      • Sendai Kousei Hospital
  • Niigata
    • Niigata-shi, Niigata, Japan, 951-8566
      • Recruiting
      • Niigata Cancer Center Hospital
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
      • Recruiting
      • Okayama University Hospital
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Recruiting
      • Kansai Medical University Hospital
    • Osaka-shi, Osaka, Japan, 541-8567
      • Recruiting
      • Osaka International Cancer Institute
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Recruiting
      • Kindai University Hospital
    • Sakai-shi, Osaka, Japan, 591-8555
      • Recruiting
      • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Saitama
    • Kitaadachi-gun, Saitama, Japan, 362-0806
      • Recruiting
      • Saitama Cancer Center
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Recruiting
      • Shizuoka Cancer Center
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Recruiting
      • Juntendo University Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • Recruiting
      • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Tottori
    • Yonago-shi, Tottori, Japan, 683-8504
      • Recruiting
      • Tottori University Hospital
  • Wakayama
    • Wakayama-shi, Wakayama, Japan, 641-8510
      • Recruiting
      • Wakayama Medical University Hospital
  • Yamaguchi
    • Ube-shi, Yamaguchi, Japan, 755-0241
      • Recruiting
      • National Hospital Organization Yamaguchi-Ube Medical Center
• Korea, Republic of
  • Goyang-si Gyeonggi-do, Korea, Republic of, 10408
    • Recruiting
    • National Cancer Center
  • Incheon, Korea, Republic of, 405-835
    • Recruiting
    • Gachon University Gil Hospital
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
• Latvia
  • Riga, Latvia, 1002
    • Recruiting
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, 1079
    • Recruiting
    • Riga East Clinical University Hospital
• Netherlands
  • Amersfoort, Netherlands, 3813 TZ
    • Recruiting
    • Meander Medisch Centrum
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • Universitair Medisch Centrum Groningen
  • Harderwijk, Netherlands, 3844 DG
    • Recruiting
    • Sint Jansdal Ziekenhuis
  • Maastricht, Netherlands, 6229 HX
    • Recruiting
    • Maastricht Universitair Medisch Centrum
  • Tilburg, Netherlands, 5022 GC
    • Recruiting
    • Elisabeth-TweeSteden Ziekenhuis
  • Zwolle, Netherlands, 8025 AB
    • Recruiting
    • Isala Klinieken
• Poland
  • Bystra, Poland, 43-630
    • Recruiting
    • Centrum Pulmonologii i Torakochirurgii w Bystrej
  • Krakow, Poland, 31-826
    • Recruiting
    • Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
  • Lublin, Poland, 20-954
    • Recruiting
    • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Poznan, Poland, 60-693
    • Recruiting
    • Med Polonia Sp zoo
  • Przemysl, Poland, 37-700
    • Recruiting
    • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
  • Warszawa, Poland, 02-781
    • Recruiting
    • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
• Portugal
  • Lisboa, Portugal, 1769-001
    • Recruiting
    • Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
  • Lisboa, Portugal, 1500-650
    • Recruiting
    • Hospital da Luz, SA
  • Porto, Portugal, 4100-180
    • Recruiting
    • Hospital CUF Porto
• Romania
  • Bucuresti, Romania, 050098
    • Recruiting
    • Spitalul Universitar de Urgenta Bucuresti
  • Bucuresti, Romania, 022328
    • Recruiting
    • Institutul Oncologic, Prof Dr Alexandru Trestioreanu
  • Cluj Napoca, Romania, 400015
    • Recruiting
    • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
  • Craiova, Romania, 200542
    • Recruiting
    • Centrul de Oncologie Sf Nectarie SRL
  • Iasi, Romania, 700483
    • Recruiting
    • Institutul Regional de Oncologie Iasi
  • Ploiesti, Romania, 100337
    • Recruiting
    • Spitalul Municipal Ploiesti
  • Timisoara, Romania, 300239
    • Recruiting
    • SC Oncomed SRL
• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
  • Andalucía
    • Sevilla, Andalucía, Spain, 41013
      • Recruiting
      • Hospital Universitario Virgen del Rocío
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla
  • Cataluña
    • Barcelona, Cataluña, Spain, 08041
      • Recruiting
      • Hospital de La Santa Creu I Sant Pau
    • Barcelona, Cataluña, Spain, 08036
      • Recruiting
      • Hospital Clinic i Provincial de Barcelona
    • Barcelona, Cataluña, Spain, 08003
      • Recruiting
      • Hospital del Mar
    • Hospitalet de Llobregat, Cataluña, Spain, 08908
      • Recruiting
      • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
• Sweden
  • Goteborg, Sweden, 413 45
    • Recruiting
    • Sahlgrenska Universitetssjukhuset
  • Gävle, Sweden, 801 87
    • Recruiting
    • Gavle Sjukhus
• Switzerland
  • Aarau, Switzerland, 5001
    • Recruiting
    • Kantonsspital Aarau
  • Baden, Switzerland, 5404
    • Recruiting
    • Kantonsspital Baden
  • Basel, Switzerland, 4031
    • Recruiting
    • Universitaetsspital Basel
• Taiwan
  • Tainan, Taiwan, 70403
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • Recruiting
    • National Taiwan University Hospital
• Thailand
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Maharaj Nakorn Chiang Mai Hospital
• Turkey
  • Ankara, Turkey, 06800
    • Recruiting
    • Ankara Bilkent Sehir Hastanesi
  • Denizli, Turkey, 20070
    • Recruiting
    • Pamukkale Universitesi Tip Fakultesi Hastanesi
  • Istanbul, Turkey, 34098
    • Recruiting
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi
  • Istanbul, Turkey, 34722
    • Recruiting
    • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
  • Istanbul, Turkey, 34214
    • Recruiting
    • Bagcilar Medipol Mega Universite Hastanesi
  • Izmir, Turkey, 35575
    • Recruiting
    • Izmir Ekonomi Universitesi Medical Point Hastanesi
• United Kingdom
  • Inverness, United Kingdom, IV2 3UJ
    • Recruiting
    • Raigmore Hospital
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois at Chicago
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Recruiting
      • University of New Mexico Cancer Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center Hillman Cancer Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center Knoxville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
• No history of systemic anticancer therapy in metastatic/non-curable settings
• Eastern Cooperative Oncology Group (ECOG) ≤ 1

Exclusion Criteria:

• Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
• Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved
• Symptomatic (treated or untreated) brain metastases
• Gastrointestinal (GI) tract disease causing the inability to take oral medication
• Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
• Prior therapy with a KRAS G12C inhibitor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sotorasib combined with carboplatin and pemetrexed; Sotorasib administered in combination with carboplatin and pemetrexed.	Drug: Sotorasib; Oral administration; Other Names: AMG 510; LUMYKRAS ®; LUMAKRAS ®
Active Comparator: Pembrolizumab combined with carboplatin and pemetrexed; Pembrolizumab administered in combination with carboplatin and pemetrexed.	Drug: Pembrolizumab; Intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).	From Baseline up to end of study (EOS) (approximately 5.5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1, per BICR.	From Baseline up to EOS (approximately 5.5 years)
Overall Survival (OS)	OS is defined as the time from randomization until death due to any cause.	From Baseline up to EOS (approximately 5.5 years)
Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score		From Baseline to Week 12
Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale		From Baseline to Week 12
Change in QLQ-LC13 Symptoms of Cough Subscale		From Baseline to Week 12
Change in QLQ-LC13 Symptoms of Chest Pain Subscale		From Baseline to Week 12
Change in Physical Function as Measured by QLQ-C30		From Baseline to Week 12
Change in Global Health Status as Measured by QLQ-C30		From Baseline to Week 12
Progression-free Survival 2 (PFS2)	PFS2 is defined as the time from randomization to progression per investigator after initiation of new anticancer therapy or treatment beyond progression (ie, second progression) or death from any cause, whichever occurs first.	From Baseline up to EOS (approximately 5.5 years)
Change in QLQ-LC13 Subscale Scores		From Baseline up to EOS (approximately 5.5 years)
Change in QLQ-C30 Subscale Scores		From Baseline up to EOS (approximately 5.5 years)
Time to Deterioration in QLC-LC13 Subscale Scores		From Baseline to Week 12
Time to Deterioration in QLC-C30 Subscale Scores		From Baseline to Week 12
Change in Summary Scores and Visual Analogue Scale (VAS) Scores	Measured by EuroQol-5 Dimension (EQ-5D-5L).	From Baseline up to EOS (approximately 5.5 years)
Duration of Response	Duration of response is defined as the time from the first documentation of objective response until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.	From Baseline up to EOS (approximately 5.5 years)
Time to Response	Defined as the time from randomization to first evidence of PR or CR per BICR.	From Baseline up to EOS (approximately 5.5 years)
Disease Control	Defined as CR plus PR plus stable disease based on RECIST v1.1 per BICR.	From Baseline up to EOS (approximately 5.5 years)
PFS	Based on investigator tumor assessments per RECIST v1.1.	From Baseline up to EOS (approximately 5.5 years)
Objective Response	Based on investigator tumor assessments per RECIST v1.1.	From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Treatment-Emergent Adverse Events		From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Clinically Significant Changes in Vital Signs		From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests		From Baseline up to EOS (approximately 5.5 years)
Maximum Plasma Concentration (Cmax) of Sotorasib		Pre-dose Day 1 up to Day 64
Minimum Plasma Concentration (Cmin) of Sotorasib		Pre-dose Day 1 up to Day 64
Area Under The Curve (AUC) of Sotorasib		Pre-dose Day 1 up to Day 64

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): February 14, 2026
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer; NSCLC; Pembrolizumab; Carboplatin; Oncology; PD-L1; Pemetrexed; Sotorasib; AMG 510; KRAS p.G12C; PD-L1 Negative; CodeBreaK 202; LUMAKRAS ®; LUMYKRAS ®
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab; Sotorasib
• Other Study ID Numbers: 20190341; 2022-501863-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No