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Tyrosine Kinase Inhibitor

osimertinib for Lung Adenocarcinoma

Phase 2
Waitlist Available
Led By Azam Ghafoor, M.D.
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
OR -- Progressive disease after 1st or 2nd generation EGFR TKI therapy harboring somatic T790M mutation (Cohort 2)
In patients with suspected leptomeningeal disease, the diagnosis of leptomeningeal disease should be confirmed by the presence of neurological or imaging signs and/or positive CSF cytology.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date treatment consent signed to date off study, approximately 74 months and 16 days, 65 months and 16 days, and 40 months and 4 days for the first, second and third group respectively.
Awards & highlights

Study Summary

This study is evaluating whether a surgery which reduces blood flow in a stomach artery leads to significant weightloss.

Eligible Conditions
  • Lung Adenocarcinoma
  • Lung Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date treatment consent signed to date off study, approximately 74 months and 16 days, 65 months and 16 days, and 40 months and 4 days for the first, second and third group respectively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and date treatment consent signed to date off study, approximately 74 months and 16 days, 65 months and 16 days, and 40 months and 4 days for the first, second and third group respectively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All Grades 1, Grade 2, Grade 3, Grade 4, and/or Grade 5 Adverse Events Possibly, Probably, and/or Definitely Related to Local Ablative Therapy (LAT)
All Grades 1, Grade 2, Grade 3, Grade 4, and/or Grade 5 Adverse Events Possibly, Probably, and/or Definitely Related to Osimertinib
Number of Participants Who Had Osimertinib Acquired Resistant Mechanisms Identified on Tumors
+5 more
Secondary outcome measures
Best Overall Response (BOR)
Best Overall Response - All Participants
Disease Control Rate (DCR)
+2 more
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Side effects data

From 2022 Phase 2 trial • 17 Patients • NCT03434418
76%
Diarrhea
53%
Fatigue
41%
Anorexia
41%
Weight loss
35%
Dyspnea
29%
Abdominal pain
29%
Vomiting
24%
Maculopapular rash
24%
Acneiform rash
24%
Cough
6%
Respiratory failure
6%
Thromboembolic event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Osimertinib

Trial Design

3Treatment groups
Experimental Treatment
Group I: Tyrosine Kinase Inhibitor Naïve Epidermal Growth Factor Receptor *mutated Non Small Cell Lung CancerExperimental Treatment2 Interventions
Cohort 1 - Osimertinib followed by LAT followed by osimertinib. Single daily dose of osimertinib until progression. The starting dose of osimertinib will be 80 mg per day for participants without leptomeningeal disease and 160 mg per day for those with leptomeningeal disease at baseline. *including germline T790M mutation
Group II: Epidermal Growth Factor Receptor mutated Non Small Cell Lung Cancer Progressed on OsimertinibExperimental Treatment2 Interventions
Cohort 3 - LAT followed by Osimertinib. Participants may undergo 1 of 3 local ablative procedures after initial progression on Osimertinib: surgery, radiotherapy, radiofrequency ablation. The starting dose of Osimertinib will be 80 mg per day for participants without leptomeningeal disease and 160 mg per day for those with leptomeningeal disease at baseline. Single daily dose of Osimertinib until progression.
Group III: EGFR mutated NSCLC Progressed on prior 1st/2nd Generation EGFR TKI therapy &acquired T790M MutationExperimental Treatment2 Interventions
Cohort 2 - Osimertinib followed by LAT followed by osimertinib. Participants may undergo 1 of 3 local ablative procedures after initial progression on osimertinib: surgery, radiotherapy, or radiofrequency ablation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
osimertinib
2018
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,653 Previous Clinical Trials
40,932,524 Total Patients Enrolled
Azam Ghafoor, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
6 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib
Azam Ghafoor 2016. "Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02759835.
~4 spots leftby Apr 2025
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