Platinum Doublet Chemotherapy and Proton Beam Radiation Therapy in Treating Patients With Stage II-III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
This randomized phase II trial studies how well platinum doublet chemotherapy and proton beam radiation therapy work in treating patients with stage II-III non-small cell lung cancer that cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as carboplatin, paclitaxel, etoposide, cisplatin, and pemetrexed work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Giving platinum doublet chemotherapy and proton beam radiation therapy may work better in treating patients with non-small cell lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 6 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 25, 2025 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Mayo Clinic
- Interventions being studied
- Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Drug: Paclitaxel; Drug: Pemetrexed; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Age \>= 18 years
- Histological confirmation of non-small cell lung cancer
- Forced expiratory volume in 1 second (FEV1) \> 1.0 L
- Unresectable or medically inoperable stage 2-3 non-small cell lung cancer (based on computed tomography/positron emission tomography \[CT/PET\], magnetic resonance imaging \[MRI\] or CT of brain, and physical exam);
- Eligible if recurrence after surgery and now has the equivalent stage 2-3 non-small cell lung cancer (NSCLC) OR had sub totally resected stage 2-3 NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
- White blood cell (WBC) \>= 3.0 x 10\^9/L
- Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
- Hemoglobin (Hgb) \>= 9 g/dl
- Platelets (plts) \> 100 x 10\^9/L
- Serum creatinine \< 1.5 x upper limits of normal (ULN)
- Serum bilirubin \< 1.5 x ULN
- Provide informed written consent
- Willing to return to enrolling institution for follow-up for a minimum of 1 year
- Ability to undergo potentially curative chemotherapy plus radiotherapy
- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Weight loss of \> 10% in the past 3 months
- Distant metastases (M1 disease)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, lupus, usual interstitial pneumonitis (UIP), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any investigational agent, that would be considered as a treatment for the primary neoplasm
- Active second malignancy
- History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Received chemotherapy for lung cancer within 6 months of registration
- Previous chest radiotherapy that would overlap with the proton field
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic in RochesterRochester, Minnesota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 25, 2025. Always confirm current availability with the study team.