Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients
Real-world study of Sotorasib in Chinese lung cancer patients
Plain English Summary
Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients is a Not Applicable clinical trial sponsored by Amgen studying Non-Small Cell Lung Cancer. This study looks at how safe Sotorasib is for lung cancer patients in China. It is for adult patients in China with a specific type of non-small cell lung cancer (NSCLC) that has spread or cannot be removed by surgery. Patients in this study have already received Sotorasib as part of their treatment. This is an observational study, meaning researchers collect information on patients already taking the drug, rather than assigning them to a treatment group. The trial aims to enroll 102 participants.
Official Summary
The primary objective of this study is to characterize the safety profile of sotorasib.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults (18 years or older) who have been diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) with a specific genetic mutation (KRAS p.G12C). Patients must have received at least one dose of Sotorasib and at least one prior cancer treatment. Patients must be of Chinese ethnicity. Individuals who are not of Chinese ethnicity cannot participate. This trial is studying Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will track how many patients experience side effects from Sotorasib, including serious ones, to understand its overall safety profile. The specific primary outcome measures are: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Up to approximately 4 years); Number of Participants with Adverse Events of Interest, Inclusive of Hepatotoxicity, Interstitial Lung Disease/Pneumonitis, and Renal Toxicity (Up to approximately 4 years); Number of Participants with Treatment-related Adverse Events (AEs) (Up to approximately 4 years); Number of Participants with Treatment-related AEs of Grade 3 or Worse (Up to approximately 4 years); Number of Participants with Serious Treatment-related AEs (Up to approximately 4 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it will provide real-world data on the safety of Sotorasib in a specific patient population, helping to fill a gap in understanding its use outside of controlled clinic This research targets Non-Small Cell Lung Cancer, where improved treatment options are needed.
Investor Insight
This study focuses on a targeted therapy for a specific lung cancer mutation, indicating a growing market for personalized cancer treatments and a competitive landscape for KRAS G12C inhibitors.
Is This Trial Right for Me?
Ask your doctor if Sotorasib is right for you and what potential side effects to watch for. This study involves reviewing your medical records and how you responded to Sotorasib treatment. You will be monitored for side effects over approximately 4 years. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 102 participants
Interventions
- DRUG: Sotorasib — Participants will have received sotorasib orally daily until disease progression or unacceptable toxicity.
Primary Outcomes
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Up to approximately 4 years)
- Number of Participants with Adverse Events of Interest, Inclusive of Hepatotoxicity, Interstitial Lung Disease/Pneumonitis, and Renal Toxicity (Up to approximately 4 years)
- Number of Participants with Treatment-related Adverse Events (AEs) (Up to approximately 4 years)
- Number of Participants with Treatment-related AEs of Grade 3 or Worse (Up to approximately 4 years)
- Number of Participants with Serious Treatment-related AEs (Up to approximately 4 years)
Secondary Outcomes
- Overall Survival (OS) from Initial Date of Sotorasib Use to Date of Death (Up to approximately 4 years)
Full Eligibility Criteria
Inclusion Criteria: * Adult (≥ 18 years) as of the index date. * KRAS p.G12C-mutated locally advanced or metastatic NSCLC. * Received at least 1 dose of sotorasib. * Receipt of at least 1 prior systemic therapy before use of sotorasib. * Obtained ICF, if required. Exclusion Criteria: * Documentation of being a non-Chinese ethnicity.
Trial Locations
- Boao Evergrande International Hospital, Qionghai, Hainan, China
- Boao Super Hospital, Qionghai, Hainan, China
- Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine Hainan Boao Research Hospital, Qionghai, Hainan, China
Frequently Asked Questions
What is clinical trial NCT07143513?
NCT07143513 is a Not Applicable OBSERVATIONAL study titled "Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients." It is currently completed and is sponsored by Amgen. The trial targets enrollment of 102 participants.
What conditions does NCT07143513 study?
This trial investigates treatments for Non-Small Cell Lung Cancer. The primary condition under study is Non-Small Cell Lung Cancer.
What treatments are being tested in NCT07143513?
The interventions being studied include: Sotorasib (DRUG). Participants will have received sotorasib orally daily until disease progression or unacceptable toxicity.
What does Not Applicable mean for NCT07143513?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07143513?
This trial is currently "Completed." It started on 2025-08-11. The estimated completion date is 2025-12-07.
Who is sponsoring NCT07143513?
NCT07143513 is sponsored by Amgen. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07143513?
The trial aims to enroll 102 participants. The trial status is completed.
How is NCT07143513 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07143513?
The primary outcome measures are: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Up to approximately 4 years); Number of Participants with Adverse Events of Interest, Inclusive of Hepatotoxicity, Interstitial Lung Disease/Pneumonitis, and Renal Toxicity (Up to approximately 4 years); Number of Participants with Treatment-related Adverse Events (AEs) (Up to approximately 4 years); Number of Participants with Treatment-related AEs of Grade 3 or Worse (Up to approximately 4 years); Number of Participants with Serious Treatment-related AEs (Up to approximately 4 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07143513 being conducted?
This trial is being conducted at 3 sites, including Qionghai, Hainan (China).
Where can I find official information about NCT07143513?
The official record for NCT07143513 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07143513. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07143513 testing in simple terms?
This study looks at how safe Sotorasib is for lung cancer patients in China. It is for adult patients in China with a specific type of non-small cell lung cancer (NSCLC) that has spread or cannot be removed by surgery.
Why is this trial significant?
This trial is important because it will provide real-world data on the safety of Sotorasib in a specific patient population, helping to fill a gap in understanding its use outside of controlled clinic
What are the potential risks of participating in NCT07143513?
The most common risks include side effects that emerge during treatment, such as liver problems, lung inflammation, or kidney issues. Serious side effects, including those that are severe (Grade 3 or worse), will be carefully monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07143513?
Ask your doctor if Sotorasib is right for you and what potential side effects to watch for. This study involves reviewing your medical records and how you responded to Sotorasib treatment. You will be monitored for side effects over approximately 4 years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07143513 signal from an investment perspective?
This study focuses on a targeted therapy for a specific lung cancer mutation, indicating a growing market for personalized cancer treatments and a competitive landscape for KRAS G12C inhibitors. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Patients in this study have already received Sotorasib as part of their treatment. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.