Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Chemotherapy; Drug: Icotinib+chemotherapy

• Registration Number: NCT01707329
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-05
• Last Update Posted: 2015-09-09
• Primary Completion: 2016-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
• No previous targeted treatment such as gefitinib, erlotinib.
• With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria
• WHO performance status(PS)<= 2
• N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST&ALT should <3ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
• Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria

• Allergic to icotinib
• Patients with metastatic brain tumors with symptoms.
• Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Chemotherapy	Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
Icotinib+Chemotherapy	Icotinib+chemotherapy	Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	6 months	A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant; are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.

Secondary Outcome Measures

Name	Time	Method
Overall survival	12 months	Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.

Trial Locations

Locations (6)

Hunan Province Tumor Hospital; 🇨🇳 Changsha, Hunan, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital of Medical School of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China