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New treatment option for Non Small Cell Lung Cancer
Official title Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)
ClinicalTrials.gov ID: NCT06305715
What this study is testing
What is Targeted TKI therapy?
Targeted TKI therapy is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part 1
- Age ≥18 years.
- Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).
- An identifiable primary lung lesion must be present based on the consensus opinion of the medical oncology and radiation oncology investigators.
- Patient did not previously receive radiation therapy to the primary lung lesion. Previous or concurrent palliative radiation to symptomatic...
You likely can't join if
- Anticipated prognosis \< 3 months.
- Inability to swallow oral medications or history of GI abnormality that would impair absorption of oral medications.
- Patients with prior or concurrent malignancy are eligible provided the investigator assesses this malignancy does not have potential to interfere...
- Patient must not have any unresolved toxicities from prior cancer therapy greater than CTCAE grade 2 at time of study enrollment. Any grade alopecia...
- Patient must not have medical contraindications, as determined by treating radiation oncologist, that would preclude safe delivery of radiation...
- Women must not be pregnant or breast-feeding. All females of childbearing potential must have negative blood or urine pregnancy testing within 14...
See the full eligibility criteria
- Part 1
- Age ≥18 years.
- Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).
- An identifiable primary lung lesion must be present based on the consensus opinion of the medical oncology and radiation oncology investigators.
- Patient did not previously receive radiation therapy to the primary lung lesion. Previous or concurrent palliative radiation to symptomatic metastatic lesions and definitive radiation to central nervous system...
- Patient must have advanced disease, either stage IV or stage IIIB/C that is not amenable to definitive multi-modality therapy.
- Patient must not have received prior targeted therapy for NSCLC. A subject may receive up to 2 cycles of standard cytotoxic chemotherapy for NSCLC prior to trial enrollment. For example, a cycle of carboplatin and...
- Patient must have measurable disease as defined by RECIST v1.1.
- Patient must have Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
- Ability to understand a written informed consent document, and the willingness to sign it. Part 2 1\. Must have an actionable driver mutation for which an Food and Drug Administration (FDA) -approved and/or National...
- Anticipated prognosis \< 3 months.
- Inability to swallow oral medications or history of GI abnormality that would impair absorption of oral medications.
- 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 how well it works of the study...
- 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.
- Patient must not have medical contraindications, as determined by treating radiation oncologist, that would preclude safe delivery of radiation therapy.
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.