Phase 2 N=20 Randomized Treatment

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

Recurrent Lung Non-Small Cell Carcinoma · Stage II Lung Cancer AJCC v8 · Stage III Lung Cancer AJCC v8 · Unresectable Lung Non-Small Cell Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT03132532 ↗

Enrolled (actual)

Serious AEs

52.6%

Results posted

Nov 2025

Primary outcome: Primary: Proportion of Participants With Progression Free Survival (PFS) — 0.6; 0.429 proportion of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Carboplatin (Drug); Cisplatin (Drug); Etoposide (Drug); Paclitaxel (Drug); Pemetrexed (Drug); Proton Beam Radiation Therapy (Radiation); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants With Progression Free Survival (PFS)	0.6; 0.429	—
SECONDARY Overall Survival (OS)	4; 2; 6; 5	—
SECONDARY Number of Participants With Adverse Events	9; 6; 6; 5	—
SECONDARY Proportion of Participants With Local-regional Failure	0.2; 0.14	—
SECONDARY Proportion of Participants With Distant Metastasis	0.1; 0.29	—

Summary

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.

Eligibility Criteria

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 = = 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03132532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.