Clinical trial 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?
An investigational chemotherapy drug being studied for locally advanced non‑small cell lung cancer. It is designed to kill or stop tumor cells by forming DNA crosslinks that interfere with cell replication.
Also referred to as Carboplatin.
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
- The study compares the usual treatment of radiation, chemotherapy and immunotherapy with the same treatment plus SBRT to see if the added radiation improves outcomes.
- Who it's for
- Adults with locally advanced, inoperable non‑small cell lung cancer (stage IIB or III).
- What's involved
- Participants receive the standard radiation and chemotherapy, then either continue with immunotherapy or targeted therapy, and some also get SBRT, a short course of highly focused radiation delivered with special equipment. Visits include regular imaging, blood tests, and routine follow‑up appointments.
- Time commitment
- The trial lasts several months of treatment followed by follow‑up visits over the next year or more to monitor progress and side effects.
- 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
- 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
- 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.
- 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
- 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 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).
- Centrally located primary tumor \< 2 cm from involved nodal disease that would result in significant overlap of the primary SBRT and nodal radiation fields.
- 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 is enrolling
- 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
- Modesto, California, United States
- Mountain View, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Mateo, California, United States
+ 326 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, but 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?
This study is enrolling now at 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 340 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.