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Small Molecule Inhibitor

Sotorasib + Tarloxotinib for Non-Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Medical University of South Carolina
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 from the date of first study drug dose to the date of death by any cause, up to approximately 100 months.
Awards & highlights

Study Summary

This trial is testing a new combination drug to treat KRAS G12C mutation NSCLC that has progressed despite other small molecule treatments.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first study drug dose to the date of death by any cause, up to approximately 100 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first study drug dose to the date of death by any cause, up to approximately 100 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response
Secondary outcome measures
Best overall response
Disease control rate
Duration of Response
+2 more

Side effects data

From 2022 Phase 1 trial • 20 Patients • NCT04887064
14%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Normal Hepatic Function
Moderate Hepatic Impairment
Severe Hepatic Impairment

Trial Design

2Treatment groups
Experimental Treatment
Group I: STAGE 2: EFFICACY (n=12)Experimental Treatment1 Intervention
EFFICACY (n=12)
Group II: STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)Experimental Treatment1 Intervention
SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs

Find a Location

Who is running the clinical trial?

Rain Therapeutics Inc.Industry Sponsor
4 Previous Clinical Trials
277 Total Patients Enrolled
Rain Oncology IncIndustry Sponsor
8 Previous Clinical Trials
314 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
940 Previous Clinical Trials
7,396,959 Total Patients Enrolled

Media Library

Sotorasib (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05313009 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored), STAGE 2: EFFICACY (n=12)
Non-Small Cell Lung Cancer Clinical Trial 2023: Sotorasib Highlights & Side Effects. Trial Name: NCT05313009 — Phase 1 & 2
Sotorasib (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05313009 — Phase 1 & 2
~2 spots leftby Jun 2025
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