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Small Molecule

Sotorasib for Advanced Non-Small Cell Lung Cancer (CodeBreaK201 Trial)

Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

CodeBreaK201 Trial Summary

This trial is testing a new cancer drug to see if it is effective at treating tumors that have a specific genetic mutation.

Who is the study for?
This trial is for adults with Stage IV NSCLC who have not been treated before, have a specific KRAS mutation (G12C), and either low PD-L1 levels or an STK11 co-mutation. They should be in good physical condition (ECOG score of 0 or 1) and cannot have had certain treatments within specified time frames.Check my eligibility
What is being tested?
The study tests two doses of Sotorasib (960 mg daily or 240 mg daily) to see how well it works on tumors with low PD-L1 levels (<1%) and/or STK11 co-mutations. The effectiveness will be measured by the change in tumor size according to RECIST criteria.See study design
What are the potential side effects?
While the side effects for this trial are not listed here, common side effects of cancer drugs like Sotorasib may include diarrhea, fatigue, nausea, liver issues, coughing, and shortness of breath among others.

CodeBreaK201 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is at stage IV and I haven't received treatment for this stage yet.
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My cancer has a PD-L1 score under 1% or an STK11 mutation.
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I am 18 or older with non-small cell lung cancer.
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My lung cancer has a specific KRAS G12C mutation.
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I do not have any active cancer spread to my brain.
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My cancer can be measured by standard criteria.

CodeBreaK201 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years 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 Rate (OR)
Secondary outcome measures
Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib
Disease Control Rate
Duration of Reponse (DOR)
+10 more

CodeBreaK201 Trial Design

2Treatment groups
Experimental Treatment
Group I: Sotorasib: 960 mg DailyExperimental Treatment1 Intervention
Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 960 mg daily. Participants will be stratified by known presence of STK11 mutation.
Group II: Sotorasib: 240 mg DailyExperimental Treatment1 Intervention
Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 240 mg daily. Participants will be stratified by known presence of STK11 mutation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotorasib
2021
Completed Phase 1
~370

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,354 Previous Clinical Trials
1,383,102 Total Patients Enrolled
MDStudy DirectorAmgen
898 Previous Clinical Trials
920,779 Total Patients Enrolled

Media Library

Sotorasib (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04933695 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Sotorasib: 960 mg Daily, Sotorasib: 240 mg Daily
Non-Small Cell Lung Cancer Clinical Trial 2023: Sotorasib Highlights & Side Effects. Trial Name: NCT04933695 — Phase 2
Sotorasib (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04933695 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide a summary of the experiments that have utilized Sotorasib?

"The initial trial of Sotorasib was conducted at Centre Hospitalier Intercommunal de Créteil in 2018. Subsequently, 5 studies have been completed and 11 currently active trials are being held in McKinney, New york and other locations."

Answered by AI

Are there any still opportunities to join this trial?

"According to clinicaltrials.gov, this research study is currently not enrolling new patients since its last update on November 29th 2022. While the trial has concluded recruitment for now, there are still 1426 other trials actively seeking participants."

Answered by AI

How many individuals are being accepted into this medical trial?

"This research trial is no longer seeking enrolment. It was first posted on January 28th 2022, and the latest update came out November 29th 2022. If you are in search of other studies, there are currently 1415 clinical trials for non-small cell lung cancer that have open admission as well 11 Sotorasib related projects admitting new participants."

Answered by AI

What potentially harmful effects can Sotorasib have on individuals?

"Sotorasib's safety is rated a 2 as there are only some reports of its efficacy, but the data on its security has been established."

Answered by AI

What indications is Sotorasib commonly prescribed to treat?

"Sotorasib is mostly used to treat conditions that were unresponsive to prior platinum therapy and can be applied in the form of a therapeutic procedure, one systemic treatment regimen, or malignant neoplasms."

Answered by AI

Are there numerous locations in the city that are conducting this experiment?

"This clinical trial is being conducted at 35 different medical centres and hospitals, including Texas Oncology- Mckinney in McKinney, Texas Oncology-Dallas Presbyterian Hospital in New york, and Laura and Isaac Perlmutter Cancer Center at New York University Langone in Syracuse."

Answered by AI

Is this research innovative and cutting-edge?

"Research into Sotorasib began in 2018, and after a successful initial trial sponsored by Amgen involving 713 participants, the drug was approved for Phases 1 & 2. Currently 11 clinical trials are taking place worldwide across 28 countries in 632 cities."

Answered by AI
~9 spots leftby Nov 2024