Non-small Cell Lung Cancer Clinical Trial
— CodeBreaK201Official 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)
| Verified date | October 2023 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 42 |
| Est. completion date | November 14, 2024 |
| Est. primary completion date | November 14, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Universite Catholique de Louvain Cliniques Universitaires Saint Luc | Bruxelles | |
| Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
| Belgium | Jessa Ziekenhuis - Campus Virga Jesse | Hasselt | |
| Belgium | Centre Hospitalier Universitaire de Liege - Sart Tilman | Liege | |
| Denmark | Odense Universitetshospital | Odense C | |
| France | Institut Sainte Catherine | Avignon cedex 9 | |
| France | Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette | Lille Cedex | |
| France | Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren | Limoges Cedex | |
| France | Centre Hospitalier Universitaire de Montpellier - Val d Aurelle | Montpellier Cedex 5 | |
| France | Hopital Cochin | Paris | |
| France | Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque | Pessac Cedex | |
| France | Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou | Rennes | |
| France | Centre Hospitalier de Nantes - Hôpital Nord Laënnec | Saint Herblain | |
| France | Hôpital Sainte Musse | Toulon Cedex | |
| France | Centre Hospitalier Universitaire de Toulouse - Hopital Larrey | Toulouse Cedex 9 | |
| Germany | Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main | Frankfurt am Main | |
| Germany | Asklepios - Fachkliniken München-Gauting | Gauting | |
| Germany | Universitätsklinikum Köln | Koeln | |
| Italy | Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo | Monza (MB) | |
| Italy | Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi | Napoli | |
| Italy | Azienda Ospedaliera Universitaria San Luigi Gonzaga | Orbassano (TO) | |
| Italy | Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano | Rome | |
| Netherlands | Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis | Amsterdam | |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | Cataluña |
| Spain | Hospital del Mar | Barcelona | Cataluña |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid |
| Spain | Hospital Clinico Universitario de Santiago | Santiago de Compostela | Galicia |
| Spain | Hospital Universitari i Politecnic La Fe | Valencia | Comunidad Valenciana |
| Sweden | Gavle Sjukhus | Gavle | |
| Sweden | Sahlgrenska Universitetssjukhuset | Goteborg | |
| Sweden | Universitetssjukhuset i Linkoping | Linkoping | |
| Sweden | Skanes Universitetssjukhus | Lund | |
| Sweden | Norrlands Universitetssjukhus | Umea | |
| Turkey | Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi | Ankara | |
| Turkey | Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi | Edirne | |
| Turkey | Koc Universitesi Hastanesi | Istanbul | |
| United States | Alabama Oncology | Birmingham | Alabama |
| United States | James J Peters VA Medical Center | Bronx | New York |
| United States | Medical University of South Carolina, Hollings Cancer Center | Charleston | South Carolina |
| United States | Texas Oncology - Baylor | Dallas | Texas |
| United States | Texas Oncology - Flower Mound | Dallas | Texas |
| United States | Texas Oncology - Medical City Dallas | Dallas | Texas |
| United States | Texas Oncology - Plano East | Dallas | Texas |
| United States | Texas Oncology-Dallas Presbyterian Hospital | Dallas | Texas |
| United States | Texas Oncology-Denton | Denton | Texas |
| United States | City of Hope at Long Beach Elm | Duarte | California |
| United States | City of Hope National Medical Center | Duarte | California |
| United States | Duke University Medical Center, Morris Cancer Clinic | Durham | North Carolina |
| United States | Englewood Hospital and Medical Center | Englewood | New Jersey |
| United States | Frederick Memorial Hospital | Frederick | Maryland |
| United States | Oncology Consultants PA | Houston | Texas |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
| United States | Baptist MD Anderson Cancer Center | Jacksonville | Florida |
| United States | Gundersen Health System | La Crosse | Wisconsin |
| United States | Baptist Health Lexington | Lexington | Kentucky |
| United States | Northwest Georgia Oncology Centers PC | Marietta | Georgia |
| United States | Texas Oncology- Mckinney | McKinney | Texas |
| United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
| United States | Laura and Isaac Perlmutter Cancer Center at New York University Langone | New York | New York |
| United States | Northport Veterans Affairs Medical Center | Northport | New York |
| United States | Texas Oncology - Northeast Texas | Paris | Texas |
| United States | Allegheny Health Network Cancer Institute at Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | University of Pittsburgh Medical Center Cancer Pavillion | Pittsburgh | Pennsylvania |
| United States | State University of New York Upstate Medical University | Syracuse | New York |
| United States | Arizona Oncology Associates Professional Corporation | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate (OR) | OR is defined as the total of Complete Response (CR) and Partial Response (PR). | Up to 6 years | |
| Secondary | Disease Control Rate | Up to 6 years | ||
| Secondary | Duration of Reponse (DOR) | Up to 6 years | ||
| Secondary | Time to Response (TTR) | Up to 6 years | ||
| Secondary | Progression-free Survival (PFS) | Up to 6 years | ||
| Secondary | Overall Survival (OS) | Up to 6 years | ||
| Secondary | Number of Participants with a Treatment-emergent Adverse Event (TEAE) | Day 1 up to Month 13 | ||
| Secondary | Number of Participants with a Treatment-related Adverse Event | Day 1 up to Month 13 | ||
| Secondary | Number of Participants with a Clinically Significant Change from Baseline in Vital Signs | Baseline (Screening; up to 28 days pre-dose) up to Month 13 | ||
| Secondary | Number of Participants with a Clinically Significant Change from Baseline in Electrocardiograms (ECGs) | Baseline (Screening; up to 28 days pre-dose) up to Month 13 | ||
| Secondary | Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests | Baseline (Screening; up to 28 days pre-dose) up to Month 13 | ||
| Secondary | Maximum Plasma Concentration (Cmax) of Sotorasib | Day 1 up to Month 3 | ||
| Secondary | Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib | Day 1 up to Month 3 | ||
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib | Day 1 up to Month 3 |
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