Non-Small Cell Lung CancerNCT07143513
Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients
An observational study of Non-Small Cell Lung Cancer, run by Amgen at 3 sites in China.
Trial summary
The primary objective of this study is to characterize the safety profile of sotorasib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Sotorasib
- Type of treatment
- Pill or oral medicine
- How many people
- 102 participants
- Where
- 3 sitesChina
- Study dates
- 11 Aug 2025to 7 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population is adult participants with KRAS p.G12C-mutated locally advanced or metastatic NSCLC and previously treated with at least 1 prior systemic therapy that have received sotorasib treatment in BOAO Pilot Zone.
Who may be able to join
- 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.
Who cannot join
- Documentation of being a non-Chinese ethnicity.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Boao Evergrande International Hospital
Qionghai, Hainan, 571400
Boao Super Hospital
Qionghai, Hainan, 571499
Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine Hainan Boao Research Hospital
Qionghai, Hainan, 57400
About this study
The primary objective of this study is to characterize the safety profile of sotorasib.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Sotorasib
- Keywords
- Non-Small Cell Lung Cancer, Sotorasib, AMG 510
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotorasibDrug
Also called AMG 510
Participants will have received sotorasib orally daily until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Participants Treated with Sotorasib | Adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) and previously treated with at least 1 prior systemic therapy that have received sotorasib treatment in either location of BOAO Pilot Zone will be included in this cohort.
The duration of evidence collection is from initiation of sotorasib to the end of study period, up to approximately 4 years from the date of the first available sotorasib use in BOAO Pilot Zone of around August 2021. Receives: Drug: Sotorasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 4 years
Number of Participants with Adverse Events of Interest, Inclusive of Hepatotoxicity, Interstitial Lung Disease/Pneumonitis, and Renal Toxicity
Measured: Up to approximately 4 years
Number of Participants with Treatment-related Adverse Events (AEs)
Measured: Up to approximately 4 years
Number of Participants with Treatment-related AEs of Grade 3 or Worse
Measured: Up to approximately 4 years
Number of Participants with Serious Treatment-related AEs
Measured: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Treatment Discontinuation
Measured: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Dose Reduction
Measured: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Death
Measured: Up to approximately 4 years
Secondary outcomes (1)
Overall Survival (OS) from Initial Date of Sotorasib Use to Date of Death
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start11 Aug 2025
- Primary completion7 Dec 2025
- Study completion7 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143513
- Sponsor's protocol ID
- 20240175
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT07143513
- Acronym / sponsor ID
- 20240175
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Sotorasib, AMG 510
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 7 Dec 2025 (actual)
- Study completion
- 7 Dec 2025 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to characterize the safety profile of sotorasib.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese Participants Treated with Sotorasib | – | Drug: SotorasibAdult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) and previously treated with at least 1 prior systemic therapy that have received sotorasib treatment in either location of BOAO Pilot Zone will be included in this cohort. The duration of evidence collection is from initiation of sotorasib to the end of study period, up to approximately 4 years from the date of the first available sotorasib use in BOAO Pilot Zone of around August 2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is adult participants with KRAS p.G12C-mutated locally advanced or metastatic NSCLC and previously treated with at least 1 prior systemic therapy that have received sotorasib treatment in BOAO Pilot Zone.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Documentation of being a non-Chinese ethnicity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotorasibAlso: AMG 510Participants will have received sotorasib orally daily until disease progression or unacceptable toxicity. | Drug | Chinese Participants Treated with Sotorasib |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 4 years
Number of Participants with Adverse Events of Interest, Inclusive of Hepatotoxicity, Interstitial Lung Disease/Pneumonitis, and Renal Toxicity
Time frame: Up to approximately 4 years
Number of Participants with Treatment-related Adverse Events (AEs)
Time frame: Up to approximately 4 years
Number of Participants with Treatment-related AEs of Grade 3 or Worse
Time frame: Up to approximately 4 years
Number of Participants with Serious Treatment-related AEs
Time frame: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Treatment Discontinuation
Time frame: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Dose Reduction
Time frame: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Death
Time frame: Up to approximately 4 years
1 secondary outcome
Overall Survival (OS) from Initial Date of Sotorasib Use to Date of Death
Time frame: Up to approximately 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
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)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Amgen at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to approximately 4 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.