NCT02787473

A Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Docetaxel Consolidation in Patients With Inoperable Squamous Cell Lung Cancer

A Phase II Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Docetaxel Consolidation in Patients With Inoperable Stage IIIA/B Squamous Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned.

Conditions

• Squamous Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	pemetrexed	Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles
DRUG	cisplatin	Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles
RADIATION	thoracic radiation therapy	Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin
DRUG	docetaxel	Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-10-01
• Completion: 2020-09-01
• First posted: 2016-06-01
• Last updated: 2016-11-25

Locations

1 site across 1 country: China