CompletedPhase 2NCT03132532

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.

Checked against the public recordLast updated Nov 25, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations2
SponsorMayo Clinic
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

04
Study sites

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.

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