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JOURNAL ONKOLOGIE – STUDIE

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)

Rekrutierend

NCT-Nummer:
NCT05920356

Studienbeginn:
November 2023

Letztes Update:
09.08.2024

Wirkstoff:
Sotorasib, Pembrolizumab

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 257)

Klinikum Chemnitz GmbH
09113 Chemnitz
(Sachsen)
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Universitaetsmedizin Goettingen
37075 Goettingen
(Niedersachsen)
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Klinikverbund Allgaeu
87439 Kempten
(Bayern)
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Klinikum der LMU Muenchen
80366 Muenchen
(Bayern)
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University of Illinois Chicago
60612 Chicago
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Norton Cancer Institute - Brownsboro
40241 Louisville
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University of New Mexico Cancer Center
87131 Albuquerque
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Memorial Sloan Kettering Cancer Center
10065 New York
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University of Pittsburgh Medical Center
15232 Pittsburgh
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University of Tennessee Medical Center Knoxville
37920 Knoxville
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Hospital Britanico de Buenos Aires
C1280AEB Caba
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Instituto Alexander Fleming
C1426ANZ Capital Federal
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C1012AAR Ciudad Autónoma de Buenos Aires
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Hospital Italiano de La Plata
B1900AUR La Plata
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Fundacion Ars Medica
4600 San Salvador de Jujuy
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Centro Oncologico Korben
1426 Buenos Aires
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F5300COE La Rioja
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Centro de Diagnostico Investigacion y Tratamiento
4400 Salta
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Concord Repatriation General Hospital
2139 Concord
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GenesisCare -North Shore Oncology
2065 St Leonards
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2298 Waratah
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4102 Woolloongabba
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Cancer Research South Australia
5000 Adelaide
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Peter MacCallum Cancer Centre
3000 Melbourne
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9020 Klagenfurt
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9000 Gent
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3000 Leuven
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4000 Liège
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2800 Mechelen
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66053-000 Belem
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50070-550 Recife
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90610-000 Porto Alegre
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11075-900 Santos
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01509-900 Sao Paulo
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22250-905 Rio de Janeiro
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01236-030 São Paulo
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01246-000 São Paulo
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346000 Talca
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510080 Guangzhou
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530021 Nanning
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611135 Chengdu
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30029 Nimes cedex 9
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31059 Toulouse Cedex 9
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37044 Tours Cedex 9
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69400 Villefranche Sur Saone Cedex
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54007 Thessaloniki
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57001 Thessaloniki
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1121 Budapest
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8582 Farkasgyepu
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8000 Szekesfehervar
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2800 Tatabanya
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2045 Torokbalint
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IRCCS Istituto Tumori Giovanni Paolo II
70124 Bari
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95123 Catania
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50134 Firenze
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47014 Meldola (FC)
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20133 Milano
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20900 Monza (MB)
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Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
80131 Napoli
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80138 Napoli
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43126 Parma
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Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
06156 Perugia
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Nagoya University Hospital
466-8560 Nagoya-shi
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036-8563 Hirosaki-shi
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National Cancer Center Hospital East
277-8577 Kashiwa-shi
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791-0280 Matsuyama-shi
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811-1395 Fukuoka-shi
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807-8556 Kitakyushu-shi
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830-0011 Kurume-shi
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720-0001 Fukuyama-shi
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003-0804 Sapporo-shi
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650-0046 Kobe-shi
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665-0827 Takarazuka-shi
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920-8641 Kanazawa-shi
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216-8511 Kawasaki-shi
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241-8515 Yokohama-shi
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606-8507 Kyoto-shi
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951-8566 Niigata-shi
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700-8558 Okayama-shi
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573-1191 Hirakata-shi
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541-8567 Osaka-shi
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589-8511 Osakasayama-shi
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591-8555 Sakai-shi
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362-0806 Kitaadachi-gun
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113-8431 Bunkyo-ku
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135-8550 Koto-ku
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683-8504 Yonago-shi
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641-8510 Wakayama-shi
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755-0241 Ube-shi
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10408 Goyang-si Gyeonggi-do
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405-835 Incheon
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02841 Seoul
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05505 Seoul
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06351 Seoul
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1002 Riga
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1079 Riga
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44680 Guadalajara
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3813 TZ Amersfoort
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3844 DG Harderwijk
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6229 HX Maastricht
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5022 GC Tilburg
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15-540 Bialystok
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43-630 Bystra
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20-090 Lublin
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37-700 Przemysl
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02-781 Warszawa
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1769-001 Lisboa
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4464-513 Matosinhos
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022328 Bucuresti
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050098 Bucuresti
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400015 Cluj Napoca
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200542 Craiova
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700483 Iasi
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100337 Ploiesti
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119228 Singapore
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41013 Sevilla
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35016 Las Palmas de Gran Canaria
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39008 Santander
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08041 Barcelona
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46010 Valencia
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70403 Tainan
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06800 Ankara
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34214 Istanbul
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Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Progression-free Survival (PFS) (Time Frame - From Baseline up to end of study (EOS) (approximately 5.5 years)):
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).



Secondary outcome:

1. Objective Response Rate (ORR) (Time Frame - From Baseline up to EOS (approximately 5.5 years)):
Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1, per BICR.

2. Overall Survival (OS) (Time Frame - From Baseline up to EOS (approximately 5.5 years)):
OS is defined as the time from randomization until death due to any cause.

3. Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score (Time Frame - From Baseline to Week 12)

4. Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale (Time Frame - From Baseline to Week 12)

5. Change in QLQ-LC13 Symptoms of Cough Subscale (Time Frame - From Baseline to Week 12)

6. Change in QLQ-LC13 Symptoms of Chest Pain Subscale (Time Frame - From Baseline to Week 12)

7. Change in Physical Function as Measured by QLQ-C30 (Time Frame - From Baseline to Week 12)

8. Change in Global Health Status as Measured by QLQ-C30 (Time Frame - From Baseline to Week 12)

9. Progression-free Survival 2 (PFS2) (Time Frame - From Baseline up to EOS (approximately 5.5 years)):
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.

10. Change in QLQ-LC13 Subscale Scores (Time Frame - From Baseline up to EOS (approximately 5.5 years))

11. Change in QLQ-C30 Subscale Scores (Time Frame - From Baseline up to EOS (approximately 5.5 years))

12. Time to Deterioration in QLC-LC13 Subscale Scores (Time Frame - From Baseline to Week 12)

13. Time to Deterioration in QLC-C30 Subscale Scores (Time Frame - From Baseline to Week 12)

14. Change in Summary Scores and Visual Analogue Scale (VAS) Scores (Time Frame - From Baseline up to EOS (approximately 5.5 years)):
Measured by EuroQol-5 Dimension (EQ-5D-5L).

15. Duration of Response (Time Frame - From Baseline up to EOS (approximately 5.5 years)):
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.

16. Time to Response (Time Frame - From Baseline up to EOS (approximately 5.5 years)):
Defined as the time from randomization to first evidence of PR or CR per BICR.

17. Disease Control (Time Frame - From Baseline up to EOS (approximately 5.5 years)):
Defined as CR plus PR plus stable disease based on RECIST v1.1 per BICR.

18. PFS (Time Frame - From Baseline up to EOS (approximately 5.5 years)):
Based on investigator tumor assessments per RECIST v1.1.

19. Objective Response (Time Frame - From Baseline up to EOS (approximately 5.5 years)):
Based on investigator tumor assessments per RECIST v1.1.

20. Number of Participants With Treatment-Emergent Adverse Events (Time Frame - From Baseline up to EOS (approximately 5.5 years))

21. Number of Participants With Clinically Significant Changes in Vital Signs (Time Frame - From Baseline up to EOS (approximately 5.5 years))

22. Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests (Time Frame - From Baseline up to EOS (approximately 5.5 years))

23. Maximum Plasma Concentration (Cmax) of Sotorasib (Time Frame - Pre-dose Day 1 up to Day 64)

24. Minimum Plasma Concentration (Cmin) of Sotorasib (Time Frame - Pre-dose Day 1 up to Day 64)

25. Area Under The Curve (AUC) of Sotorasib (Time Frame - Pre-dose Day 1 up to Day 64)

Studien-Arme

  • Experimental: Sotorasib combined with carboplatin and pemetrexed
    Sotorasib administered in combination with carboplatin and pemetrexed.
  • Active Comparator: Pembrolizumab combined with carboplatin and pemetrexed
    Pembrolizumab administered in combination with carboplatin and pemetrexed.

Geprüfte Regime

  • Sotorasib (AMG 510 / LUMYKRAS ® / LUMAKRAS ® / ):
    Oral administration
  • Pembrolizumab:
    Intravenous administration

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"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)"

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