Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC

Betta Pharmaceuticals

Status and phase: Unknown; Phase 4

Conditions: EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma

Treatments: Drug: Maintenance icotinib; Drug: Sequential and maintenance icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02194556

BD-IC-IV69

Details and patient eligibility

About

This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage IV or IIIB advanced non-small cell lung cancer patients
• Positive EGFR Mutation
• Non-progressive disease after first-line gemcitabine/cisplatin therapy
• Measurable lesion according to RECIST 1.1 with at least one measurable lesion

Exclusion criteria

• Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
• Patients with wild-type EGFR
• Evidence of interstitial lung diseases
• Severe hypersensitivity to icotinib or any of the excipients of this product.
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Sequential and maintenance icotinib

Experimental group

Description:

Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.

Treatment:

Drug: Sequential and maintenance icotinib

Maintenance icotinib

Active Comparator group

Description:

Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib (125 mg three times per day) as maintenance treatment until disease progression or intolerable toxicity.

Treatment:

Drug: Maintenance icotinib