NCT02103257

Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.

Conditions

• EGFR Positive Non-small Cell Lung Cancer
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Sequential Icotinib Plus Chemotherapy	Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
DRUG	Icotinib	Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-03-01
• Completion: 2017-09-01
• First posted: 2014-04-03
• Last updated: 2015-04-29

Locations

31 sites across 1 country: China