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Small Molecule Drug
Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC
Phase 2
Waitlist Available
Led By Hossein Borghaei, DO
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial tests sotorasib, an oral medication, in newly diagnosed patients with stage Ib-IIIa NSCLC who have a KRAS G12C mutation. The drug aims to shrink tumors by blocking growth signals in cancer cells. Sotorasib is the first FDA-approved targeted therapy for KRAS G12C-mutated non-small cell lung cancer (NSCLC).
Eligible Conditions
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Major pathologic response
Secondary study objectives
Determine the safety, feasibility and tolerability of neoadjuvant sotorasib therapy in patients with surgically resectable KRAS G12C mutant NSCLC
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,373 Total Patients Enrolled
Hossein Borghaei, DOPrincipal InvestigatorFox Chase Cancer Center
3 Previous Clinical Trials
93 Total Patients Enrolled