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 (CodeBreaK201)
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| ClinicalTrials.gov Identifier: NCT04933695 |
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Recruitment Status :
Active, not recruiting
First Posted : June 22, 2021
Last Update Posted : April 21, 2023
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-small Cell Lung Cancer | Drug: Sotorasib | Phase 2 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 42 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | 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) |
| Actual Study Start Date : | January 28, 2022 |
| Estimated Primary Completion Date : | August 23, 2024 |
| Estimated Study Completion Date : | August 23, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
Drug Information available for:
Sotorasib
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sotorasib: 960 mg Daily
Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 960 mg daily. Participants will be stratified by known presence of STK11 mutation.
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Drug: Sotorasib
Oral tablet
Other Names:
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Experimental: Sotorasib: 240 mg Daily
Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 240 mg daily. Participants will be stratified by known presence of STK11 mutation.
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Drug: Sotorasib
Oral tablet
Other Names:
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Primary Outcome Measures :
- Objective Response Rate (OR) [ Time Frame: Up to 6 years ]OR is defined as the total of Complete Response (CR) and Partial Response (PR).
Secondary Outcome Measures :
- Disease Control Rate [ Time Frame: Up to 6 years ]
- Duration of Reponse (DOR) [ Time Frame: Up to 6 years ]
- Time to Response (TTR) [ Time Frame: Up to 6 years ]
- Progression-free Survival (PFS) [ Time Frame: Up to 6 years ]
- Overall Survival (OS) [ Time Frame: Up to 6 years ]
- Number of Participants with a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Day 1 up to Month 13 ]
- Number of Participants with a Treatment-related Adverse Event [ Time Frame: Day 1 up to Month 13 ]
- Number of Participants with a Clinically Significant Change from Baseline in Vital Signs [ Time Frame: Baseline (Screening; up to 28 days pre-dose) up to Month 13 ]
- Number of Participants with a Clinically Significant Change from Baseline in Electrocardiograms (ECGs) [ Time Frame: Baseline (Screening; up to 28 days pre-dose) up to Month 13 ]
- Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests [ Time Frame: Baseline (Screening; up to 28 days pre-dose) up to Month 13 ]
- Maximum Plasma Concentration (Cmax) of Sotorasib [ Time Frame: Day 1 up to Month 3 ]
- Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib [ Time Frame: Day 1 up to Month 3 ]
- Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib [ Time Frame: Day 1 up to Month 3 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04933695
Locations
Show 67 study locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT04933695 |
| Other Study ID Numbers: |
20190288 2021-002638-18 ( EudraCT Number ) |
| First Posted: | June 22, 2021 Key Record Dates |
| Last Update Posted: | April 21, 2023 |
| Last Verified: | April 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| 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. |
| 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. |
| URL: | http://www.amgen.com/datasharing |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Amgen:
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Non-small cell lung cancer KRAS p.G12C Sotorasib AMG 510 |
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Sotorasib Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Antineoplastic Agents |