Sapanisertib + Osimertinib for Non-Small Cell Lung Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must be taking: Osimertinib

Must not be taking: Antiretrovirals, Corticosteroids, PPIs, others

Disqualifiers: Uncontrolled diabetes, Interstitial lung disease, Active infections, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of sapanisertib when given together with osimertinib in treating patients with stage IV EGFR mutation positive non-small cell lung cancer that has progressed after treatment with an EGFR tyrosine kinase inhibitor. Sapanisertib and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Penelope A. Bradbury

Principal Investigator

University Health Network Princess Margaret Cancer Center LAO

Eligibility Criteria

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.

Inclusion Criteria

I am mostly self-sufficient and can carry out daily activities.

Your blood test results must meet specific requirements for white blood cells, red blood cells, platelets, kidney function, liver function, blood sugar, and heart function.

My non-squamous NSCLC has a specific EGFR mutation.

Exclusion Criteria

Any serious intercurrent or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol

Your heart's pumping ability is lower than it should be.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients receive sapanisertib and osimertinib to determine the safety and recommended phase II dose

28 days

Daily oral administration

Dose Expansion

Evaluate the safety and preliminary efficacy of the drug combination

28 days per cycle, repeated

Daily oral administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days, then every 8 weeks

Treatment Details

Interventions

• Osimertinib
• Sapanisertib

Trial Overview 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.

Participant Groups

Group I: Treatment (sapanisertib, osimertinib) Experimental Treatment 4 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.

Osimertinib is already approved in United States, European Union for the following indications:

Approved in United States as Tagrisso for:

• Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
• Metastatic EGFR T790M mutation-positive NSCLC

Approved in European Union as Tagrisso for:

• Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
• Metastatic EGFR T790M mutation-positive NSCLC

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+