Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Betta Pharmaceuticals

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Chemotherapy; Drug: Experimental

Study type: Interventional

Funder types: Industry

Identifiers

NCT01665417

BD-IC-IV08

Details and patient eligibility

About

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

Full description

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib.

Primary endpoint:

Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib

Secondary endpoint:

1. Overall survival between icotinib and chemotherapy
2. Time to Progression between icotinib and chemotherapy
3. Objective response rate and disease control rate between icotinib and chemotherapy

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 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; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).

Exclusion criteria

• Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents 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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100 participants in 3 patient groups

Experimental Icotinib

Experimental group

Description:

Icotinib: 125mg, oral administration, three times per day.

Treatment:

Drug: Experimental

Chemotherapy Regimen 1

Active Comparator group

Description:

Chemotherapy Regimen 1：Pemetrexe 500 mg/m\^2 on Day 1, Cisplatin 75 mg/m\^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Treatment:

Drug: Chemotherapy

Drug: Chemotherapy

Chemotherapy Regimen 2

Active Comparator group

Description:

Chemotherapy Regimen 2：Docetaxel 75 mg/m\^2 on Day 1, Cisplatin 75 mg/m\^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Treatment:

Drug: Chemotherapy

Drug: Chemotherapy