Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

Betta Pharmaceuticals

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Sequential Icotinib Plus Chemotherapy; Drug: Icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02103257

BD-IC-IV62

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Sequential icotinib plus chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Sequential Icotinib Plus Chemotherapy

Icotinib

Active Comparator group

Description:

Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.

Treatment:

Drug: Icotinib