A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (VITAL)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Non Small Cell Lung; Carcinoma

Treatments: Drug: Dexamethasone (pre- and post-medication for docetaxel); Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®); Drug: Placebo; Drug: Docetaxel (Taxotere®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00532155

EFC10261

EudraCT 2007-000819-29

Details and patient eligibility

About

The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.

Full description

The study included:

• A screening visit of up to 21 days prior to randomization
• Randomization at baseline (Treatment was initiated with 3 days of randomization)
• A treatment period with 3-week treatment cycles until the participant met the following discontinuation criteria: had progressive disease, had unacceptable toxicity, or refused further study treatment
• A post study treatment follow-up period (a visit was scheduled every 8 weeks until death or end of study)

Enrollment: 913 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological/cytological proven locally advanced or metastatic non-small cell lung cancer
• Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Adequate renal, liver and bone marrow functions

Exclusion criteria

• Squamous histology/cytology
• Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
• Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 25% of bone marrow
• Prior docetaxel treatment
• Uncontrolled hypertension

The above information was not intended to contain all considerations relevant to participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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913 participants in 2 patient groups, including a placebo group

Aflibercept/Docetaxel

Experimental group

Description:

Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.

Treatment:

Drug: Docetaxel (Taxotere®)

Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

Drug: Dexamethasone (pre- and post-medication for docetaxel)

Placebo/Docetaxel

Placebo Comparator group

Description:

Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.

Treatment:

Drug: Docetaxel (Taxotere®)

Drug: Placebo

Drug: Dexamethasone (pre- and post-medication for docetaxel)