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EGFR Tyrosine Kinase Inhibitor

Sapanisertib + Osimertinib for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Penelope A Bradbury
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
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Patients with stage IV or recurrent/metastatic histologically or cytologically confirmed non-squamous NSCLC with EGFR activating mutation (Exon 21 L858R, Exon 19 deletion)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the combination of sapanisertib and osimertinib to treat patients with lung cancer that has progressed after treatment with an EGFR tyrosine kinase inhibitor.

Who is the study for?
This trial is for adults with stage IV non-small cell lung cancer that has specific EGFR mutations and worsened after treatment with an EGFR inhibitor. Participants must have good physical function, measurable disease, meet certain lab criteria, not be pregnant or breastfeeding, and able to consent. Those with serious illnesses, certain heart conditions, or taking drugs that interact badly with the trial medications cannot join.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: MLN0128 (TAK-228) and AZD9291 (Osimertinib), to find out their side effects together and the best doses for treating advanced lung cancer. The goal is to see if these drugs can block enzymes needed for cancer cells to grow.See study design
What are the potential side effects?
Potential side effects include issues affecting organs due to enzyme inhibition which may lead to abnormal blood tests results reflecting liver or kidney function changes; gastrointestinal symptoms; fatigue; skin reactions; risk of infections due to immune system impact; and possible interference with heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly self-sufficient and can carry out daily activities.
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My non-squamous NSCLC has a specific EGFR mutation.
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My cancer has worsened despite taking osimertinib as a first treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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 (DLT) of sapanisertib in combination with osimertinib in patients with EGFRm NSCLC
Maximum tolerated dose of sapanisertib in combination with osimertinib in patients with EGFRmutant (m) non-small cell lung cancer (NSCLC)
Secondary outcome measures
Biomarkers of response and resistance to the combination, explored by studying baseline biopsies, resistance biopsies, and serial plasma deoxyribonucleic acid specimens
Disease control rate
Disease control rate of patients with T790M- NSCLC in an expansion cohort
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sapanisertib, osimertinib)Experimental Treatment4 Interventions
Patients receive sapanisertib PO QD on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 (day 1 is omitted in cycle 1). Patients also receive osimertinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sapanisertib
2016
Completed Phase 2
~840
Osimertinib
2017
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,117 Total Patients Enrolled
Penelope A BradburyPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
1 Previous Clinical Trials
62 Total Patients Enrolled

Frequently Asked Questions

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

Is this research project still open to recruiting participants?

"According to information available on clinicaltrials.gov, the recruitment period for this medical trial has come to a close. First posted on October 13th 2016, it was last updated July 15th 2022 and is no longer enrolling participants - although 3768 other studies are looking for volunteers presently."

Answered by AI

How many people may be enrolled in this clinical experiment?

"At this time, the trial is no longer seeking participants. It was originally opened on October 13th 2016 and closed down on July 15th 2022. If you are searching for other medical studies, there are currently 3659 clinical trials recruiting patients with non-small cell lung carcinoma and 109 research initiatives actively looking to enroll individuals in studies of Sapanisertib."

Answered by AI

Is Sapanisertib safe enough to be administered to humans?

"The safety of Sapanisertib has been judged by our Power team with a level 1 rating, as this is an early-stage study and there is only limited data on its efficacy and hazard profile."

Answered by AI

Are there any previous investigations involving Sapanisertib?

"First examined back in 2013, sapanisertib has been subject to 641 completed studies. At present, there are 109 active clinical trials primarily being conducted out of New Haven, Connecticut."

Answered by AI

What is the ultimate goal of this trial?

"This medical experiment will be conducted across a period of 28 days and aims to determine the highest tolerable dose of sapanisertib when administered in tandem with osimertinib for patients affected by EGFRmutant (m) non-small cell lung cancer. Secondary objectives include assessing disease control rate, pharmacokinetic profiles, and response rate through standard descriptive methods such as summary statistics mean, median counts & proportions. Treatment details like modifications, best responses & time to progression will also be tracked per patient."

Answered by AI

Is this particular medical experiment an unprecedented endeavor?

"Currently, 109 studies utilizing Sapanisertib are ongoing in 1075 cities and 51 countries. The first such clinical trial was sponsored by AstraZeneca back in 2013 and included 603 patients; since then, a total of 641 trials have been successfully concluded."

Answered by AI

How widely dispersed is this experiment being implemented?

"Patients are able to enrol in this study at 5 different sites located in New Haven, Toronto and Tampa, along with 2 further locations. To lighten the burden of participation, it is recommended that individuals select the clinic nearest them."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer
2017. "Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02503722.
~1 spots leftby Jun 2024
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