At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed advanced lung adenocarcinoma with EGFR-sensitizing somatic mutations or germline T790M mutation (detected histologically or via ctDNA analysis using CLIA assay)
- ✓Cohort 1: No prior EGFR TKI therapy; Cohort 2: Progressive disease after 1st or 2nd generation EGFR TKI therapy with somatic T790M mutation; Cohort 3: Progressive disease after osimertinib treatment eligible for local ablative therapy
- ✓Age ≥18 years
- ✓Presence of measurable disease per RECIST version 1.1
- ✕Unresolved toxicities from prior therapy greater than CTCAE grade 1 (except alopecia and grade 2 platinum-related neuropathy)
- ✕CNS metastases that are neurologically unstable
- ✕History of interstitial lung disease, drug-induced ILD, radiation pneumonitis requiring steroids, or active ILD
- ✕Uncontrolled arrhythmia or myocardial infarction in the last 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-mutated, Non-Small Cell Lung Cancer (NSCLC) After Treatment With Osimertinib (AZD9291, Tagrisso)
In Brief
A Phase 2 clinical trial evaluating osimertinib and Local Ablative Therapy (LAT) for Lung Adenocarcinoma and Lung Neoplasms. Completed, enrolled 37 participants across 1 site.
Detailed Summary
Background: Some non-small-cell lung cancers (NSCLC) have a mutation in a gene that makes a protein called EGFR. This particular cancer can be treated with certain drugs such as erlotinib (Tarceva), gefitinib (Iressa) and osimertinib (Tagrisso). But many tumors become resistant to these drugs because of a second mutation. Researchers want to test if adding local ablative therapy (LAT) extends the benefits of the drug, osimertinib. LAT can include techniques such as surgery, radiofrequency ablation, cryotherapy or radiation therapy. Objective: To test if re-taking osimertinib after LAT is safe, tolerable, and effective for people whose NSCLC has progressed after initial treatment with osimertinib. Eligibility: Adults ages 18 and older with certain types of NSCLC. Participants will be divided into various groups as described below. Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Tumor scans Eye exam Review of tumor sample. Participants will take the study drug by mouth once a day. They will continue until they can no longer tolerate it or their disease worsens. They will keep a dosage diary. All participants will start each 21-day course with physical exam; blood, urine, and saliva tests; and electrocardiogram. They will have scans every 6 weeks and echocardiogram every 3 months. Groups 1 and 2 will: Start osimertinib right away. Have LAT if their disease progresses and is suitable for LAT. If LAT cannot be performed or LAT consists of a procedure other than surgery, a tumor biopsy will be performed. Re-start osimertinib after LAT, or other treatments if not suitable for LAT. Group 3 will: Have LAT. If LAT consists of a procedure other than surgery, a tumor biopsy will be performed. Start osimertinib after LAT. After participants stop taking the drugs, they will have a final visit. This will include: Medical history Physical exam Blood tests Participants will be called every year for follow-up.
Study Details
Timeline
Interventions
Single daily dose of osimertinib until progression. The starting dose of osimertinib will be 80 mg per day for patients without leptomeningeal disease and 160 mg per day for those with leptomeningeal disease at baseline.
local ablative therapy. Subjects may undergo 1 of 3 local ablative procedures after initial progression on osimertinib: surgery, radiotherapy, radiofrequency ablation