Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease
- Registration Number
- NCT01690390
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- 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.
- 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 Icotinib of Routine Dose Icotinib of routine dose Oral Drug icotinib 125 mg three times per day Icotinib of High Dose Icotinib of high dose Oral Drug icotinib 250 mg three times per day
- 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 15 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.
Transformation rate from stable disease to complete response or partial response 6 weeks 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.
Incidence rate of adverse events 40 months 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.
Trial Locations
- Locations (17)
The First Affiliated Hospital of Wenzhou Medical College
🇨🇳Wenzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
Sir Run Run Shaw Hospital
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Fujian Hospital for Chest Tumors & Tuberculosis Diseases
🇨🇳Fuzhou, Fujian, China
Fujian Provincal Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Provincal Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The second hospital of Xiamen City
🇨🇳Xiamen, Fujian, China
Hunan Provincal Cancer Hospital
🇨🇳Changsha, Hunan, China
The Second People's Hospital of Sichuan
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Medical School of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Traditional Chinese Medical Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Yinzhou People's Hospital
🇨🇳Ningbo, Zhejiang, China
Ningbo Medical Treatment Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China