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 2026-09-22.
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.
Exclusion Criteria:
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
Showing the first 100 of 418 sites across 38 countries.
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, Sap, Icf, Csr
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Carcinoma, Non-Small-Cell Lung→
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