Osimertinib + SABR for Lung Cancer

Recruiting at 1 trial location

Overseen By Sawsan Rashdan, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: CYP3A4 inducers

Disqualifiers: Uncontrolled hypertension, Active infection, ILD, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

41 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates the combination of two well-tolerated therapies, osimertinib and Stereotactic Ablative Radiation (SABR).

Research Team

Sawsan Rashdan, MD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

This trial is for adults over 18 with advanced EGFR mutant NSCLC, who can't have surgery or radiotherapy. They should expect to live at least 12 weeks and have good organ function. Participants must not be pregnant, breastfeeding, or planning to get pregnant and agree to use contraception. People with certain heart conditions, uncontrolled diseases, a history of severe lung issues like ILD, or those who've had specific treatments like osimertinib are excluded.

Inclusion Criteria

Written informed consent

Patients must have a life expectancy ≥ 12 weeks.

I am not pregnant, not breastfeeding, and either cannot get pregnant or am using birth control.

Exclusion Criteria

I have had lung inflammation or damage that needed steroids.

I cannot take osimertinib due to severe nausea, vomiting, or issues with my digestive system.

You have had a bad reaction to osimertinib or similar drugs in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive osimertinib for 8 weeks to target EGFR mutant lung cancer

8 weeks

Radiation

Persisting lesions are treated with stereotactic ablative radiation (SABR) after 8 weeks of osimertinib therapy

1-2 weeks

Continued Treatment

Participants continue osimertinib therapy post-radiation; repeat SABR may be performed if progression occurs

Up to 300 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months up to 48 months

Treatment Details

Interventions

• Osimertinib
• Stereotactic Ablative Radiation (SABR)

Trial Overview The study tests the combination of Osimertinib (a drug) and Stereotactic Ablative Radiation (SABR), both known for being well-tolerated in treating non-small cell lung cancer. It aims to evaluate how effective this combo is when used together.

Participant Groups

Group I: Osimertinib Experimental Treatment 2 Interventions

Osimertinib in combination with Stereotactic Ablative Radiation (SABR)

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?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology