CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Carboplatin +7 moredrug
Likely dose
Carboplatin or Cisplatin (platinum agent) with Etoposide, Paclitaxel, or Pemetrexed (specific doses and schedules not specified in intervention text); Proton Beam Therapy (dose escalation study, specific doses not provided)AI-extracted
Key inclusion· 6
  • ✓Age ≥18 years
  • ✓Histologically confirmed non-small cell lung cancer
  • ✓Unresectable or medically inoperable stage 2-3 NSCLC, or recurrent after surgery with equivalent stage 2-3 disease, or subtotally resected stage 2-3 NSCLC
  • ✓FEV1 >1.0 L
Key exclusion· 8
  • ✕Distant metastases (M1 disease)
  • ✕Weight loss >10% in past 3 months
  • ✕Uncontrolled intercurrent illness including active infection, symptomatic heart failure, usual interstitial pneumonitis, unstable angina, cardiac arrhythmia, or psychiatric illness limiting compliance
  • ✕History of myocardial infarction ≤6 months or congestive heart failure requiring maintenance therapy for life-threatening ventricular arrhythmias

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03132532
NCT03132532Phase 2Completed
CompareCT.gov

Phase II Trial of Standard Platinum Doublet Chemotherapy + Various Proton Beam Therapy (PBT) Doses in Order to Determine the Optimal Dose of PBT for Unresectable Stage 2/3 Non-Small Cell Lung Cancer

Mayo Clinic·interventional·Posted Apr 28, 2017·Updated Nov 25, 2025

In Brief

A Phase 2 clinical trial evaluating Carboplatin, Cisplatin, and 6 other interventions for Recurrent Lung Non-Small Cell Carcinoma and 3 related conditions. Completed, enrolled 20 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Unresectable Lung Non-Small Cell Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 28, 2017
Enrollment StartJul 31, 2017
Primary CompletionDec 23, 2023
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 9.2 years ago

Interventions

Carboplatindrug

Chemotherapy

Cisplatindrug

Chemotherapy

Etoposidedrug

Chemotherapy

Paclitaxeldrug

Chemotherapy

Pemetrexeddrug

Chemotherapy

Proton Beam Radiation Therapyradiation

Undergo PBT

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies