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Alkylating Agent

Intensity-Modulated Radiation Therapy for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Steven H Lin
Research Sponsored by National Cancer Institute (NCI)
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 up to 4 years
Awards & highlights

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 Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
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
Pharmacokinetic parameters of carboplatin and paclitaxel with the dosing of trametinib
Secondary outcome measures
KRAS mutation status
Overall survival (OS)
Patterns of recurrence
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (trametinib, chemotherapy, radiation therapy)Experimental Treatment8 Interventions
CONCURRENT CHEMOTHERAPY: Patients undergo IMRT or 3D-CRT QD 5 days a week for 6 weeks. Patients receive trametinib PO QD and carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients without disease progression after completion of chemoradiation proceed to consolidation chemotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning 3 weeks after completion of concurrent chemoradiation, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on days 1 and 22. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Trametinib
2014
Completed Phase 2
~1550
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Image Guided Radiation Therapy
2016
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,137 Total Patients Enrolled
Steven H LinPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
72 Total Patients Enrolled

Frequently Asked Questions

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

In which locations is the experiment currently being conducted?

"Presently, 6 clinical trial sites are open for enrollment in this study. Those locations include Columbus, Houston and Rochester with an additional 3 centres across the country. It is advised that individuals choose a nearby site to reduce travel difficulties if they decide to become involved in the trial."

Answered by AI

Has the Pharmacological Study obtained regulatory approval from the FDA?

"Due to the limited amount of information surrounding it, our team has assigned Pharmacological Study a 1 on the safety scale. This is mainly because this trial is in its first phase and thus lacks robust data backing up both efficacy and security."

Answered by AI

What are the main aims of this clinical exploration?

"The primary endpoint of this clinical trial is to analyse Dose Limiting Toxicity (DLT) in the form of non-hematologic grade 3 or 4 adverse events at 15 minutes, 30 minutes before infusion and then again at 30 minutes, 4 hours, 10 hours and 24 ours post infusion on Day 15. Secondary objectives include assessing Patterns of Recurrence via Kaplan Meier methodologies; Response Rate based on CT scans/FDG PET/CT imaging after Chemoradiation treatment with 95% Confidence Intervals; as well as unadjusted Overall Survival estimations utilising a Kaplan Meier model."

Answered by AI

How many individuals can participate in this clinical research?

"Unfortunately, this clinical trial is not presently recruiting patients. The investigation was initially posted on October 28th 2013 and recently updated on September 20th 2022. However, 1365 trials actively enrolling non-small cell lung carcinoma sufferers as well 1261 Pharmacological Study are currently searching for participants."

Answered by AI

Have any other research endeavors been conducted on Pharmacological Study?

"Initially conducted in 1997, the Pharmacological Study has already seen 2170 trials to completion. Presently, 1261 active clinical trials are ongoing with a considerable portion taking place at Columbus, Ohio's City of Hope Comprehensive Cancer Center."

Answered by AI

Does this trial still have availability for participants?

"Affirmative, clinicaltrials.gov's data reveals that this medical trial is not currently recruiting patients; however, it was initially posted on October 28th 2013 and updated lastly on September 20th 2022. Although no longer actively searching for participants at this time, there are 2626 other trials in search of candidates presently."

Answered by AI

What maladies does Pharmacological Study commonly address?

"Pharmacological Study is a commonly utilized therapy for advanced endometrial cancer. Additionally, this medication has been demonstrated to help manage melanoma, neoplasm metastasis, and lymphoma not of the Hodgkin variety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
2013. "Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01912625.
~1 spots leftby Apr 2025
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