NCT06582771 · Memorial Sloan Kettering Cancer Center
A Study of Sotorasib in People with Non-Small Cell Lung Cancer
What this study is about
The researchers are doing this study to see if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have not received treatment for their cancer since it became advanced. (Participants have not received a "first-line therapy" since their cancer became advanced.
View original scientific description
The researchers are doing this study to see if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have not received treatment for their cancer since it became advanced. (Participants have not received a "first-line therapy" since their cancer became advanced.
Interventions
DRUG
Sotorasib
Sotorasib 960 mg (8 pills) daily
Primary outcome measures
Response to therapy
Time frame: within 6 month of therapy
will be assessed with serial CT chest/abdomen/pelvis every 2 cycles (6 weeks), with response evaluated by RECIST 1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Written informed consent
- Biopsy-proven metastatic or recurrent non-small cell lung cancer
- KRAS G12C mutation on prior tumor biopsy or cell-free DNA (cfDNA) testing
- No prior therapy in the advanced setting
- Measurable disease per RECIST 1.1
- Karnofsky performance status (KPS) ≥ 70%
- Adequate organ function
- Hemoglobin ≥ 10\^9 g/dL
- Platelets ≥ 75 x 10\^9/L
- Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
- AST \< 3 x ULN (if liver metastases are present, \< 5 x ULN)
- ALT \< 3 x ULN (if liver metastases are present, \< 5 x ULN)
- Alkaline phosphatase \< 2 x ULN (if liver or bone metastases are present,\< 3 xULN)
- Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits
- Serum creatinine \< 1.5 x ULN or if available, calculated or measured creatinine clearance \> 30 mL/min/1.73 m\^2 In addition, patients must:
- Be willing to undergo pre-treatment and day 7-2
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2026 · Source of record for eligibility and locations