A double blind clinical trial comparing the study drug and placebo as second line therapy for treatment of Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)?.

A multinational, randomized, double-blind study comparing aflibercept versus placebo in patients treated with second-line docetaxel after failure of one platinum based therapy for locally advanced or metastatic non-small-cell lung cancer (NSCLC) - VITAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000028

Enrollment

900

Registered

2008-04-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung Health Condition 2: null- Non Small Cell Lung Cancer

Interventions

Intervention1: Aflibercept+docetaxel: Aflibercept :6 mg/kg over 1 hour IV on Day 1 every 3 weeks Docetaxol 75 mg/mÂ² IV over 1 hour, on Day 1. Control Intervention1: Placebo+docetaxel: Aflibercept

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To demonstrate overall survival (OS) improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC).Timepoint: Clinical examination will be performed every 3 weeks before each treatment cycle during the treatment period and then overall survival will be evaluated by collecting status information at 2 month intervals until death or the study cut-off date, whichever comes first	—

Measure

Time frame

To demonstrate overall survival (OS) improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC).Timepoint: Clinical examination will be performed every 3 weeks before each treatment cycle during the treatment period and then overall survival will be evaluated by collecting status information at 2 month intervals until death or the study cut-off date, whichever comes first

—

Secondary

Measure	Time frame
Progression Free Survival (PFS)Timepoint: PFS is defined as time interval between the date of randomization and the time of occurrence of the first documented among the following events: â?¢ Radiological tumor progression on CT scan and /or MRI â?¢ Death due to any cause	—

Countries

Democratic People's Republic of Korea, India, Indonesia

Contacts

Public ContactGayatri Jaiswal

Sanofi Synthelabo (I) Ltd

Gayatri.jaiswal@sanofi.com02230707806

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026