Actively Recruiting
A Study of Sotorasib in People With Non-Small Cell Lung Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-25
39
Participants Needed
7
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.)
CONDITIONS
Official Title
A Study of Sotorasib in People With Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Biopsy-proven metastatic or recurrent non-small cell lung cancer
- KRAS G12C mutation confirmed by tumor biopsy or cell-free DNA testing
- No prior therapy in the advanced setting
- Measurable disease according to RECIST 1.1 criteria
- Karnofsky performance status of 70% or higher
- Age 18 years or older
- Adequate organ function including hemoglobin ≥9 g/dL, platelets ≥75 x 10^9/L, absolute neutrophil count >1.5 x 10^9/L, AST and ALT levels within specified limits depending on liver metastases, alkaline phosphatase within limits
- Total bilirubin ≤1.5 times the upper limit of normal; acceptable if Gilbert's syndrome with normal conjugated bilirubin
- Serum creatinine less than 1.5 times upper limit of normal or creatinine clearance >30 mL/min/1.73 m^2
- Willingness to undergo pre-treatment and day 7-21 on-treatment tumor biopsies
- Declining first-line chemotherapy or anti-PD-(L)1 therapy, or progression after adjuvant or consolidation therapy for early-stage NSCLC
- Women must be not of childbearing potential or using effective contraception methods and have a negative pregnancy test
- Men sexually active with women of childbearing potential must use condoms and ensure partner uses effective contraception and agree not to donate sperm during and for 7 days after treatment
You will not qualify if you...
- Symptomatic brain metastases
- Radiotherapy within 1 week before starting treatment
- Major surgery within 1 week before starting treatment
- Exposure to adjuvant or consolidation anti-PD-1 or PD-(L)1 therapy within 12 weeks before starting sotorasib
- Unresolved toxicity greater than grade 1 from prior treatment
- Prior history of pneumonitis greater than grade 1 from previous treatment
- Congestive heart failure NYHA Class III-IV or hospitalization for heart failure within 6 months
- Gastrointestinal conditions preventing oral medication or causing malabsorption
- Positive hepatitis B surface antigen or active hepatitis C infection
- Other active or chronic liver diseases
- Current participation in another investigational drug or device study or within 28 days of ending such studies
- Use of certain cytochrome P450 3A4 sensitive substrates or inducers within set timeframes unless approved
- Refusal or inability to undergo required tumor biopsies as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
G
Gregory Riely, MD, PhD
CONTACT
K
Kathryn Arbour, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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