Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC
NCT05400577 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2023-07-17
Summary
This is a single arm study, conducted at two centers, of neoadjuvant sotorasib in treatment naïve patients with stage Ib-IIIa NSCLC. The study will accrue 25 patients in all. Patients must have been deemed surgically resectable and physiologically fit for surgery by a thoracic surgeon prior to enrollment.
Conditions
Interventions
- DRUG
-
Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)
Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)
Sponsors & Collaborators
-
Fox Chase Cancer Center
lead OTHER
Principal Investigators
-
Hossein Borghaei, DO · Fox Chase Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-13
- Primary Completion
- 2024-01-01
- Completion
- 2024-02-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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