Osimertinib + Abemaciclib for Non-Small Cell Lung Cancer after Osimertinib Resistance

Recruiting in Palo Alto (17 mi)

Overseen byHatim Husain, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Lung cancer is the leading cause of cancer deaths. Advances in the systemic treatment of non-small cell lung cancer (NSCLC) have increased survival in metastatic EGFR-mutated NSCLC. However resistance to therapy can develop.

Eligibility Criteria

Adults over 18 with Stage IV, recurrent or metastatic non-small cell lung cancer that has an EGFR mutation and have shown resistance to osimertinib treatment. They must be able to swallow pills, not have serious heart conditions or uncontrolled illnesses, and agree to use contraception. Those with certain prior treatments or health issues like interstitial lung disease are excluded.

Inclusion Criteria

At least one measurable lesion according to RECIST version 1.1

Age >18 years

Histologically or cytologically confirmed NSCLC-lung adenocarcinoma histology

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Exclusion Criteria

You have a lung disease called interstitial lung disease, except if it was caused by radiation treatment and is not currently being treated or causing symptoms.

You have certain health conditions like unstable angina, congestive heart failure, or gastrointestinal diseases that may affect how well you can take the study medication. You also have mental health issues or other personal situations that may make it difficult for you to participate or follow the study requirements.

Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of osimertinib (e.g. Crohn's disease, ulcerative colitis, chronic diarrhea, and malabsorption)

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Participant Groups

The trial is testing the combination of Osimertinib and Abemaciclib in patients whose non-small cell lung cancer has become resistant to Osimertinib alone. It aims to see if this combo can overcome resistance and improve outcomes.

1Treatment groups

Experimental Treatment

Group I: Single Arm, POCExperimental Treatment2 Interventions

Single arm, POC Safety and Efficacy Osimertinib 80 mg QD Abemaciclib 150mg BID

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

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: