Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)

Description

This prospective, two-part, single-arm, phase II trial is designed to evaluate whether the use of definitive radiation to the primary lung lesion prolongs progression-free survival (PFS) in treatment-naïve, metastatic, driver-mutated non-small cell lung cancers (NSCLC) patients who are subsequently placed on a tyrosine kinase inhibitor (TKI).

Conditions

Non Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

This prospective, two-part, single-arm, phase II trial is designed to evaluate whether the use of definitive radiation to the primary lung lesion prolongs progression-free survival (PFS) in treatment-naïve, metastatic, driver-mutated non-small cell lung cancers (NSCLC) patients who are subsequently placed on a tyrosine kinase inhibitor (TKI).

Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)

Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)

Condition
Non Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Milwaukee

Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Anticipated prognosis \< 3 months.
  • 2. Inability to swallow oral medications or history of GI abnormality that would impair absorption of oral medications.
  • 3. Patients with prior or concurrent malignancy are eligible provided the investigator assesses this malignancy does not have potential to interfere with evaluation of the safety or efficacy of the study treatments.
  • 4. Patient must not have any unresolved toxicities from prior cancer therapy greater than CTCAE grade 2 at time of study enrollment. Any grade alopecia is allowable.
  • 5. Patient must not have medical contraindications, as determined by treating radiation oncologist, that would preclude safe delivery of radiation therapy.
  • 6. Women must not be pregnant or breast-feeding. All females of childbearing potential must have negative blood or urine pregnancy testing within 14 days of study enrollment.
  • 7. Women of childbearing potential and sexually active males must use effective methods of contraception for 14 days prior to study enrollment, while on study treatment, and for 4 months after the last targeted therapy treatment.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical College of Wisconsin,

Jonathan Thompson, MD, MS, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

2028-06-15