Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease

NSCLC Clinical Trial

Official title:

An Open-label, Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01690390
• Other study ID #: BD-IV-43
• Status: Recruiting
• Phase: Phase 2
• First received: September 18, 2012
• Last updated: December 26, 2014
• Start date: September 2012
• Est. completion date: July 2016

Study information

• Verified date: December 2013
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Zhang Yi Ping, M.D.
• Phone: 0086-13750881678
• Email: zyp[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purposes of this study are to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy.

Description:

This is a multi-center phase II randomized controlled study to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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) at least 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• Icotinib of routine dose
Icotinib of routine dose: 125 mg is administered orally three times per day.
• Icotinib of high dose
Icotinib: 250 mg is administered orally three times per day.

Locations

Country	Name	City	State
China	Hunan Provincal Cancer Hospital	Changsha	Hunan
China	The Second People's Hospital of Sichuan	Chengdu	Sichuan
China	Fujian Hospital for Chest Tumors & Tuberculosis Diseases	Fuzhou	Fujian
China	Fujian Provincal Cancer Hospital	Fuzhou	Fujian
China	Fujian Provincal Hospital	Fuzhou	Fujian
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Zhejiang Traditional Chinese Medical Hospital	Hangzhou	Zhejiang
China	Ningbo Medical Treatment Center Lihuili Hospital	Ningbo	Zhejiang
China	Yinzhou People's Hospital	Ningbo	Zhejiang
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	The First Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	The second hospital of Xiamen City	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	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.	6 months	No
Secondary	Overall survival	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.	15 months	No
Secondary	Transformation rate from stable disease to complete response or partial response	Number of participants with an stable disease previously achieve complete response or partial response after dose escalation. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.	6 weeks	No
Secondary	Incidence rate of adverse events	Number of patients with a adverse event, identified according to the Common Toxicity Criteria (CTC) in evaluable-for-safety population, which included all patients who received at least 1 dose of study medication.	40 months	Yes