A Phase 3 interventional study of Sotorasib and Pembrolizumab in Non-Small Cell Lung Cancer (NSCLC), sponsored by Amgen. Recruiting at 418 sites in 38 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 750 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sotorasib administered in combination with carboplatin and pemetrexed.
Drug: Sotorasib
Pembrolizumab administered in combination with carboplatin and pemetrexed.
Drug: Pembrolizumab
Oral administration
Also known as: AMG 510, LUMYKRAS ®, LUMAKRAS ®
Intravenous administration
Progression-free Survival (PFS)
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).
Time frame: Approximately 2.5 years
Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Time frame: Approximately 2.5 years
Objective Response Rate (ORR)
Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1, per BICR.
Time frame: From Baseline up to end of study (EOS) (approximately 5.5 years)
Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score
Time frame: From Baseline to Week 12
Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale
Time frame: From Baseline to Week 12
Change in QLQ-LC13 Symptoms of Cough Subscale
Time frame: From Baseline to Week 12
Change in QLQ-LC13 Symptoms of Chest Pain Subscale
Time frame: From Baseline to Week 12
Change in Physical Function as Measured by QLQ-C30
Time frame: From Baseline to Week 12
Change in Global Health Status as Measured by QLQ-C30
Time frame: From Baseline to Week 12
Progression-free Survival 2 (PFS2)
PFS2 is defined as the time from randomization to progression per investigator after initiation of new anticancer therapy or death from any cause, whichever occurs first.
Time frame: From Baseline up to EOS (approximately 5.5 years)
Change in QLQ-LC13 Subscale Scores
Time frame: From Baseline up to EOS (approximately 5.5 years)
Change in QLQ-C30 Subscale Scores
Time frame: From Baseline up to EOS (approximately 5.5 years)
Time to Deterioration in QLC-LC13 Subscale Scores
Time frame: From Baseline to Week 12
Time to Deterioration in QLC-C30 Subscale Scores
Time frame: From Baseline to Week 12
Change in Summary Scores and Visual Analogue Scale (VAS) Scores
Measured by EuroQol-5 Dimension (EQ-5D-5L).
Time frame: From Baseline up to EOS (approximately 5.5 years)
Duration of Response
Duration of response is defined as the time from the first documentation of objective response until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.
Time frame: From Baseline up to EOS (approximately 5.5 years)
Time to Response
Defined as the time from randomization to first evidence of PR or CR per BICR.
Time frame: From Baseline up to EOS (approximately 5.5 years)
Disease Control
Defined as CR plus PR plus stable disease based on RECIST v1.1 per BICR.
Time frame: From Baseline up to EOS (approximately 5.5 years)
PFS
Based on investigator tumor assessments per RECIST v1.1.
Time frame: From Baseline up to EOS (approximately 5.5 years)
Objective Response
Based on investigator tumor assessments per RECIST v1.1.
Time frame: From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests
Time frame: From Baseline up to EOS (approximately 5.5 years)
Maximum Plasma Concentration (Cmax) of Sotorasib
Time frame: Pre-dose Day 1 up to Day 64
Minimum Plasma Concentration (Cmin) of Sotorasib
Time frame: Pre-dose Day 1 up to Day 64
Area Under The Curve (AUC) of Sotorasib
Time frame: Pre-dose Day 1 up to Day 64
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Showing the first 100 of 418 sites across 38 countries. Choose a country and city above to see the rest.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · www.amgen.com
Started Nov 2023 (actual). Primary completion is estimated for Jun 2027, 43 months after the start.
Of 314 industry-sponsored phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 57. This study's planned 43 months is above that.
Counting every sponsor, half of 423 studies reached it within 45 months; a quarter within 30 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Sotorasib
Carcinoma, Non-Small-Cell Lung →