Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study
Overview
- Phase
- Phase 4
- Intervention
- Icotinib
- Conditions
- EGFR Positive Non-small Cell Lung Cancer
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Enrollment
- 192
- Locations
- 31
- Primary Endpoint
- Progression Free Survival
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)
- •Patients must have previously untreated locally advanced or metastatic NSCLC
- •EGFR activating mutation (exon 19 deletion, L858R) is required
- •Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
Exclusion Criteria
- •Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR
- •Patients with wild-type EGFR
- •Any other investigational agents are not permitted
- •Any evidence of interstitial lung disease
Arms & Interventions
Icotinib
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
Intervention: Icotinib
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.
Intervention: Sequential Icotinib Plus Chemotherapy
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 15 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
- Adverse events(24 months)
- Overall survival(24 months)
- Objective response rate(15 months)