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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)

Must not have

Patients with active malignancies other than NSCLC or prior curatively treated malignancy at high risk of relapse during the study period

No concomitant use of proton pump inhibitors (PPI) is allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have NSCLC and no other active cancers or high-risk relapse cancers.

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I am not using proton pump inhibitors.

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I do not have lung diseases, active infections, severe liver issues, bleeding disorders, or major heart/lung problems.

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I am allergic to MLN0128 (TAK-228) or osimertinib (AZD9291) or similar drugs.

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I am not currently receiving any cancer treatments.

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I am not HIV-positive or on antiretroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1120