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
Overview
- Phase
- Phase 2
- Intervention
- Icotinib of routine dose
- Conditions
- NSCLC
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Enrollment
- 180
- Locations
- 17
- Primary Endpoint
- Progression Free Survival
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Icotinib of Routine Dose
Oral Drug icotinib 125 mg three times per day
Intervention: Icotinib of routine dose
Icotinib of High Dose
Oral Drug icotinib 250 mg three times per day
Intervention: Icotinib of high dose
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 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 Outcomes
- Overall survival(15 months)
- Transformation rate from stable disease to complete response or partial response(6 weeks)
- Incidence rate of adverse events(40 months)