Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days) for Non-Small Cell Lung Carcinoma (NSCLC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Fox Chase Cancer Center, Philadelphia, PA
Non-Small Cell Lung Carcinoma (NSCLC)+2 More
Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Non-Small Cell Lung Carcinoma (NSCLC)

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 2 months

1 months
Determine the safety, feasibility and tolerability of neoadjuvant sotorasib therapy in patients with surgically resectable KRAS G12C mutant NSCLC
2 months
Major pathologic response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Non-Small Cell Lung Carcinoma (NSCLC)

Trial Design

1 Treatment Group

Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)
1 of 1
Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days) · No Placebo Group · Phase 2

Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)
Drug
Experimental Group · 1 Intervention: Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 months
Closest Location: Fox Chase Cancer Center · Philadelphia, PA
Photo of fox chase cancer center 1Photo of fox chase cancer center 2Photo of fox chase cancer center 3
2006First Recorded Clinical Trial
35 TrialsResearching Non-Small Cell Lung Carcinoma (NSCLC)
539 CompletedClinical Trials

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
214 Previous Clinical Trials
33,490 Total Patients Enrolled
4 Trials studying Non-Small Cell Lung Carcinoma (NSCLC)
82 Patients Enrolled for Non-Small Cell Lung Carcinoma (NSCLC)
Hossein Borghaei, DOPrincipal InvestigatorFox Chase Cancer Center
3 Previous Clinical Trials
93 Total Patients Enrolled
1 Trials studying Non-Small Cell Lung Carcinoma (NSCLC)
39 Patients Enrolled for Non-Small Cell Lung Carcinoma (NSCLC)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a performance status of 0 or 1.
You have a total bilirubin level that is less than 1.5 times the upper limit of normal (ULN) or less than 2.0 times the ULN for Gilbert's syndrome or less than 3.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.