CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled
Drug / intervention
cetuximab +3 morebiological
Likely dose
Pemetrexed 500 mg/m² IV every 21 days; Carboplatin AUC 5 every 21 days × 4 cycles; Cetuximab 400 mg/m² day 1 then 250 mg/m² weekly × 6 weeks; Thoracic radiotherapy 70 Gy over 7 weeksAI-extracted
Key inclusion· 8
  • ✓Histologically or cytologically confirmed NSCLC (squamous, adenocarcinoma, large cell)
  • ✓Unresectable or inoperable stage IIIA or selected IIIB disease, M0 (no distant metastasis)
  • ✓Any T with N2 or N3 disease, or T3/N1-N3 if unresectable, or T4 with any N if encompassable in radiation field
  • ✓Measurable disease ≥20 mm by conventional imaging or ≥10 mm by spiral CT
Key exclusion· 8
  • ✕Stage IIIA/IIIB with T3/N0 disease, M1 disease, or atelectasis of entire lung
  • ✕Direct vertebral body invasion or scalene/supraclavicular/contralateral hilar node involvement
  • ✕Malignant, exudative, or bloody pleural effusion
  • ✕Prior chemotherapy for NSCLC, chest radiation therapy, or therapy targeting EGFR pathway

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

Search/NCT00117962
NCT00117962Phase 2Completed
CompareCT.gov

A Randomized Phase II Study of Radiation Therapy, Pemetrexed and Carboplatin With or Without Cetuximab in Stage III Non-Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology·interventional·Posted Jul 11, 2005·Updated Oct 7, 2016

In Brief

A Phase 2 clinical trial evaluating cetuximab, carboplatin, and 2 other interventions for Lung Cancer. Completed, enrolled 109 participants across 71 sites.

Detailed Summary

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also make tumor cells more sensitive to radiation therapy. Giving pemetrexed disodium, carboplatin, and radiation therapy together with cetuximab may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium and carboplatin together with radiation therapy with or without cetuximab works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Eli Lilly and Company, Bristol-Myers Squibb

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2005
Enrollment StartSep 1, 2005
Primary CompletionMar 1, 2009
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 21.0 years ago

Interventions

cetuximabbiological

400 mg/sq m IV over 120 min: Day 1; Week 1 250 mg/sq m IV over 60 min weekly for 6 more weeks.

carboplatindrug

AUC = 5 q 21 days for 4 cycles

pemetrexed disodiumdrug

500 mg/sq m IV q 21 days during chemoradiation and consolidation chemotherapy phases

radiation therapyradiation

Thoracic radiotherapy: 70 Gy for 7 weeks beginning on Day 1.