Clinical trial NCT04933695: A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
Official title: A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
KRAS p.G12C
Sotorasib
AMG 510
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-06-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) \< 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 \< 1% and in a subgroup of participants with STK11 co-mutation.


Eligibility criteria: Inclusion Criteria:

* Adult (= or \> 18 years old) with NSCLC
* Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV disease
* Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)
* Programmed death-ligand 1 (PD-L1) TPS Score \< 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* No active brain metastases
* Measurable disease per investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Exclusion Criteria:

* Mixed small-cell lung cancer and NSCLC histology
* Myocardial Infarction within 6 months of study Day 1
* Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonists (H2RA), strong inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) or known CYP3A4 sensitive substrates or P-gp substrates
* Therapeutic or palliative radiation therapy within 2 weeks of study day 1
* Unable to take oral medication
* Unable to receive both iodinated contrast for computed tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans

Primary outcomes:
measure: Objective Response Rate (OR)
timeFrame: Up to 6 years
Secondary outcomes:
measure: Disease Control Rate
timeFrame: Up to 6 years
measure: Duration of Reponse (DOR)
timeFrame: Up to 6 years
measure: Time to Response (TTR)
timeFrame: Up to 6 years
measure: Progression-free Survival (PFS)
timeFrame: Up to 6 years
measure: Overall Survival (OS)
timeFrame: Up to 6 years
measure: Number of Participants with a Treatment-emergent Adverse Event (TEAE)
timeFrame: Day 1 up to Month 13
measure: Number of Participants with a Treatment-related Adverse Event
timeFrame: Day 1 up to Month 13
measure: Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
timeFrame: Baseline (Screening; up to 28 days pre-dose) up to Month 13
measure: Number of Participants with a Clinically Significant Change from Baseline in Electrocardiograms (ECGs)
timeFrame: Baseline (Screening; up to 28 days pre-dose) up to Month 13
measure: Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests
timeFrame: Baseline (Screening; up to 28 days pre-dose) up to Month 13
measure: Maximum Plasma Concentration (Cmax) of Sotorasib
timeFrame: Day 1 up to Month 3
measure: Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib
timeFrame: Day 1 up to Month 3
measure: Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib
timeFrame: Day 1 up to Month 3
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology Associates Professional Corporation
state: Arizona
city: Duarte
country: United States
facility: City of Hope at Long Beach Elm
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Frederick
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Bronx
country: United States
facility: James J Peters VA Medical Center
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at New York University Langone
state: New York
city: Northport
country: United States
facility: Northport Veterans Affairs Medical Center
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center, Morris Cancer Clinic
state: North Carolina
city: Pittsburgh
country: United States
facility: Allegheny Health Network Cancer Institute at Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Cancer Pavillion
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, Hollings Cancer Center
state: South Carolina
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Plano East
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Flower Mound
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor
state: Texas
city: Denton
country: United States
facility: Texas Oncology-Denton
state: Texas
city: Houston
country: United States
facility: Oncology Consultants PA
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: McKinney
country: United States
facility: Texas Oncology- Mckinney
state: Texas
city: Paris
country: United States
facility: Texas Oncology - Northeast Texas
state: Texas
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
city: Bruxelles
country: Belgium
facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Avignon cedex 9
country: France
facility: Institut Sainte Catherine
city: Lille Cedex
country: France
facility: Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette
city: Limoges Cedex
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
city: Montpellier Cedex 5
country: France
facility: Centre Hospitalier Universitaire de Montpellier - Val d Aurelle
city: Paris
country: France
facility: Hopital Cochin
city: Pessac Cedex
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
city: Saint Herblain
country: France
facility: Centre Hospitalier de Nantes - Hôpital Nord Laënnec
city: Toulon Cedex
country: France
facility: Hôpital Sainte Musse
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
city: Frankfurt am Main
country: Germany
facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
city: Gauting
country: Germany
facility: Asklepios - Fachkliniken München-Gauting
city: Koeln
country: Germany
facility: Universitätsklinikum Köln
city: Monza (MB)
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
city: Orbassano (TO)
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga
city: Rome
country: Italy
facility: Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunidad Valenciana
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: Galicia
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Gavle
country: Sweden
facility: Gavle Sjukhus
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Linkoping
country: Sweden
facility: Universitetssjukhuset i Linkoping
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus
city: Ankara
country: Turkey
facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
city: Edirne
country: Turkey
facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
city: Istanbul
country: Turkey
facility: Koc Universitesi Hastanesi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: