Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: Non Small Cell Lung Cancer (NSCLC)

Treatments: Drug: cisplatin + vinorelbine; Drug: cetuximab + cisplatin + vinorelbine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00148798

EMR 62202-046

Details and patient eligibility

About

The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.

Enrollment: 1,861 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV
• Immunohistochemical evidence of EGFR expression on tumor tissue
• Presence of at least 1 bi-dimensionally measurable index lesion, whereby index lesions must not lie in an irradiated area

Exclusion criteria

• Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR-targeting therapy
• Previous chemotherapy for NSCLC
• Documented or symptomatic brain metastasis
• Superior vena cava syndrome contra-indicating hydration
• Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,861 participants in 2 patient groups

Cetuximab plus chemotherapy

Experimental group

Description:

cetuximab + cisplatin + vinorelbine

Treatment:

Drug: cetuximab + cisplatin + vinorelbine

Chemotherapy alone

Active Comparator group

Description:

cisplatin + vinorelbine alone

Treatment:

Drug: cisplatin + vinorelbine