Osimertinib + Necitumumab for Lung Cancer

Recruiting at 16 trial locations

Overseen by Jonathan W. Riess

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I trial studies the safety, side effects and best dose of necitumumab when given together with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is stage IV or has come back after a period of improvement (recurrent) and who have progressed on a previous EGFR tyrosine kinase inhibitor. Immunotherapy with monoclonal antibodies, such as necitumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving necitumumab with osimertinib may be safe, tolerable in treating patients with EGFR-mutant non-small cell lung cancer.

Research Team

Jonathan W. Riess

Principal Investigator

City of Hope Comprehensive Cancer Center LAO

Eligibility Criteria

This trial is for adults over 18 with stage IV or recurrent non-small cell lung cancer (NSCLC) that has specific EGFR mutations and worsened after previous treatments. Participants must be able to swallow pills, have a life expectancy of more than 3 months, good organ function, and agree to use contraception. It's not for those with certain heart issues, uncontrolled illnesses, recent major surgery, interstitial lung disease history, pregnant/breastfeeding women, or HIV-positive patients on antiretrovirals.

Inclusion Criteria

You meet certain requirements for the dose escalation and expansion groups A, B, C, D, and E.

You have a specific amount of disease that can be measured using a standard method called RECIST 1.1.

You are expected to live for at least 3 more months.

Exclusion Criteria

I do not have any unmanaged ongoing illnesses.

I have a heart condition related to abnormal heart rhythms.

My heart's pumping ability is below normal.

Treatment Details

Interventions

• Necitumumab (Monoclonal Antibodies)
• Osimertinib (Tyrosine Kinase Inhibitor)

Trial Overview The trial tests the combination of two drugs: Necitumumab (an immunotherapy drug) and Osimertinib (a drug blocking enzymes needed by cancer cells). The goal is to see if this combo is better at treating NSCLC compared to current methods. Patients will also undergo various scans and provide biospecimens to assess treatment effects.

Participant Groups

Group I: Treatment (osimertinib, necitumumab) Experimental Treatment 7 Interventions

Patients receive osimertinib PO QD on days 1-21 and necitumumab IV over 60 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA and CT scan, MRI and blood sample collection throughout the study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+