Pharmacological Study for Non-Small Cell Lung Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Small Cell Lung Carcinoma+4 More
Pharmacological Study - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effects of a drug called trametinib when given with combination chemotherapy and radiation therapy to treat patients with stage III non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Non-Small Cell Lung Carcinoma

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 4 years

Day 15
Pharmacokinetic parameters of carboplatin and paclitaxel with the dosing of trametinib
Baseline
KRAS mutation status
Up to 4 years
Overall survival (OS)
Patterns of recurrence
Response rate based on CT or FDG-PET/CT imaging response assessment after completion of chemoradiation
Day 70
Dose limiting toxicity defined as any grade 3 or 4 non-hematologic toxicities according to Common Terminology Criteria for Adverse Events version 4.0 grading

Trial Safety

Safety Progress

1 of 3

Other trials for Non-Small Cell Lung Carcinoma

Trial Design

1 Treatment Group

Treatment (trametinib, chemotherapy, radiation therapy)
1 of 1
Experimental Treatment

16 Total Participants · 1 Treatment Group

Primary Treatment: Pharmacological Study · No Placebo Group · Phase 1

Treatment (trametinib, chemotherapy, radiation therapy)Experimental Group · 8 Interventions: Paclitaxel, Trametinib, Pharmacological Study, Carboplatin, 3-Dimensional Conformal Radiation Therapy, Laboratory Biomarker Analysis, Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy · Intervention Types: Drug, Drug, Other, Drug, Radiation, Other, Radiation, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Trametinib
FDA approved
Carboplatin
FDA approved
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~1660

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,872 Total Patients Enrolled
Steven H LinPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
50 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have received prior thoracic radiation and there is no cumulative esophageal dose that exceeds more than 50% of the maximal acceptable dose tolerance.
You are able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
Albumin must be greater than 2.5 g/dL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 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.