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New treatment option for Locally Advanced Lung Non-Small Cell Carcinoma
Official title Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05624996
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for locally advanced lung non-small cell carcinoma.
Also referred to as Blastocarb, Carboplat.
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 phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to the usual treatment (conventional image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib) versus the usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation therapy to tumors with high precision.
- Phase 3: a large, late-stage study
- Time commitment: about 2 weeks
- Which group you join is decided by chance.
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
- Pathologically (histologically or cytologically) proven diagnosis of non-operable stage IIB or III, node positive (American Joint Committee on Cancer...
- Patients must have an identified primary tumor and at least one nodal metastasis (peribronchial/hilar/intrapulmonary, mediastinal/subcarinal...
- Up to 4 cycles of systemic therapy received prior to registration for the current study cancer is allowable; any prior chemotherapy for a different...
- Patients who refuse surgery, in addition to those who are technically unresectable or medically inoperable, are eligible.
- Patients with separate tumor nodules in the same lobe of the primary tumor are eligible
You likely can't join if
- Prior radiotherapy to the study cancer (local recurrence). Prior radiotherapy for a different cancer/condition to the region of the study cancer that...
- Patients without identifiable primary tumor and at least 1 pathologically enlarged lymph node are not eligible (T3-4N0 or T0N1-3 patients are not...
- Centrally located primary tumor \< 2 cm from involved nodal disease that would result in significant overlap of the primary SBRT and nodal radiation...
- Participants who are pregnant or unwilling to discontinue nursing
- Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective...
See the full eligibility criteria
- Pathologically (histologically or cytologically) proven diagnosis of non-operable stage IIB or III, node positive (American Joint Committee on Cancer [AJCC] eighth edition) non-small cell lung cancer (NSCLC) with known...
- Patients must have an identified primary tumor and at least one nodal metastasis (peribronchial/hilar/intrapulmonary, mediastinal/subcarinal, supraclavicular/scalene)
- Up to 4 cycles of systemic therapy received prior to registration for the current study cancer is allowable; any prior chemotherapy for a different cancer is also permissible
- Patients who refuse surgery, in addition to those who are technically unresectable or medically inoperable, are eligible.
- Patients with separate tumor nodules in the same lobe of the primary tumor are eligible
- The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments:
- History/physical examination prior to registration;
- Magnetic resonance imaging (MRI) scan of the brain (preferred) or CT scan of the brain (if available, contrast is preferred for all neuroimaging) prior to registration;
- CT chest with IV contrast (if contrast is available and unless contraindicated, such as for abnormal kidney function) prior to registration. PET/CT may be used if the CT portion is of identical diagnostic quality as...
- No evidence of distant metastases based on FDG PET/CT scan obtained within 60 days of registration
- Primary tumor =\< 7 cm
- Age \>= 18
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Hematologic function (e.g. platelets, leukocytes, hemoglobin) amenable, at the discretion of the treating physician, to allow for treatment with chemotherapy and concurrent radiation therapy
- Creatinine clearance \>= 25 mL/min by the Cockcroft-Gault (C-G) equation
- people with non-malignant pleural effusion are eligible provided the effusion is not known or demonstrated to be an exudative effusion
- If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:
- When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative;
- Effusions that are minimal (i.e., not visible on chest x-ray) that are too small to safely tap are eligible
- Medical history consistent with the patient being amenable, at the discretion of the treating physician, to allow for treating with consolidation immunotherapy. Patients with known EGFR/ALK/other driver mutation at the...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen
- Negative pregnancy test =\< 14 days prior to registration for participants of childbearing potential
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal...
- Prior radiotherapy to the study cancer (local recurrence). Prior radiotherapy for a different cancer/condition to the region of the study cancer that would result in overlap of radiation therapy fields that is...
- Patients without identifiable primary tumor and at least 1 pathologically enlarged lymph node are not eligible (T3-4N0 or T0N1-3 patients are not eligible). At least 1 radiographically-involved lymph node is required...
- Centrally located primary tumor \< 2 cm from involved nodal disease that would result in significant overlap of the primary SBRT and nodal radiation fields. This does not include proximity to involved segmental and...
- Participants who are pregnant or unwilling to discontinue nursing
- Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy and for the Food and Drug Administration...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Daphne, Alabama, United States
- Fairhope, Alabama, United States
- Mobile, Alabama, United States
- Saraland, Alabama, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Bakersfield, California, United States
- Burlingame, California, United States
- Fremont, California, United States
- Los Angeles, California, United States
- Marysville, California, United States
- Modesto, California, United States
- Mountain View, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- Sacramento, California, United States
+ 341 more site(s).
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 study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Birmingham, Alabama, United States; Daphne, Alabama, United States; Fairhope, Alabama, United States; Mobile, Alabama, United States; Saraland, Alabama, United States; Kingman, Arizona, United States and 355 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.