Clinical trial · Interventional
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non Small Cell Lung | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) | Drug | Aflibercept | ALIAS |
| Dexamethasone (pre- and post-medication for docetaxel) | Drug | Dexamethasone | ALIAS |
| Docetaxel (Taxotere®) | Drug | Docetaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aflibercept/Docetaxel
- 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.
- interventionNames
- Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
- Drug: Docetaxel (Taxotere®)
- Drug: Dexamethasone (pre- and post-medication for docetaxel)
- type
- PLACEBO_COMPARATOR
- label
- Placebo/Docetaxel
- 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.
- interventionNames
- Drug: Placebo
- Drug: Docetaxel (Taxotere®)
- Drug: Dexamethasone (pre- and post-medication for docetaxel)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTRamlau R, Gorbunova V, Ciuleanu TE, Novello S, Ozguroglu M, Goksel T, Baldotto C, Bennouna J, Shepherd FA, Le-Guennec S, Rey A, Miller V, Thatcher N, Scagliotti G. Aflibercept and Docetaxel versus Docetaxel alone after platinum failure in patients with advanced or metastatic non-small-cell lung cancer: a randomized, controlled phase III trial. J Clin Oncol. 2012 Oct 10;30(29):3640-7. doi: 10.1200/JCO.2012.42.6932. Epub 2012 Sep 10. PMID 22965962