Clinical trial · Interventional
A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer
A Randomized, Double-Blind, Phase 2 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy
NCT01703091CI-TRIAL-00040919completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to evaluate the effects of ramucirumab in combination with docetaxel in participants with Stage IV non-small cell lung cancer who have had disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy for advanced/metastatic disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Ramucirumab | Drug | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ramucirumab plus Docetaxel
- description
- Ramucirumab 10 milligram per kilogram (mg/kg) on Day 1 of every 21 day cycle, administered as an intravenous (IV) infusion over approximately 60 minutes. Docetaxel 60 milligram per square meter (mg/m2) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.
- interventionNames
- Drug: Ramucirumab
- Drug: Docetaxel
- type
- PLACEBO_COMPARATOR
- label
- Placebo plus Docetaxel
- description
- Placebo (administered at a volume equivalent to a dose of milligram per kilogram (mg/kg)) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes. Docetaxel 60 mg/m2 on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.
- interventionNames
- Drug: Placebo
- Drug: Docetaxel
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Non-Small Cell Lung Cancer disease * Clinical stage IV or recurrent disease * One prior first-line platinum-based chemotherapy regimen with or without maintenance therapy * For Non-Small Cell Lung Cancer (NSCLC) tumors other than squamous cell histology, the epidermal growth factor receptor (EGFR) mutation status is known prior to randomization * For participants with activating epidermal growth factor receptor (EGFR) mutation only, prior epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) monotherapy (only one regimen in the setting of single use) should be utilized * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version RECIST version 1.1 * Adequate organ function * Estimated life expectancy of at least 3 months. Exclusion Criteria: * Have undergone major surgery within 28 days prior to randomization or have planned major surgery during study treatment * Receiving concurrent treatment with other anticancer therapy * Central nervous system disease other than stable and treated brain metastasis * Has major blood vessel invasion or encasement by cancer * Has intratumor cavitation * Has a history of uncontrolled thrombotic disorder * Is receiving therapeutic anticoagulation with drugs * Is receiving chronic therapy with nonsteroidal anti-inflammatory drugs * Has a history of hemoptysis within 2 months prior to randomization * Has clinically relevant congestive heart failure * Has experienced any arterial thromboembolic event * Has uncontrolled arterial hypertension * Has had a serious or nonhealing wound or, ulcer * Has significant existing conditions
References
Publications (2)
- DERIVEDMitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387. PMID 34795131
- DERIVEDYoh K, Hosomi Y, Kasahara K, Yamada K, Takahashi T, Yamamoto N, Nishio M, Ohe Y, Koue T, Nakamura T, Enatsu S, Lee P, Ferry D, Tamura T, Nakagawa K. A randomized, double-blind, phase II study of ramucirumab plus docetaxel vs placebo plus docetaxel in Japanese patients with stage IV non-small cell lung cancer after disease progression on platinum-based therapy. Lung Cancer. 2016 Sep;99:186-93. doi: 10.1016/j.lungcan.2016.07.019. Epub 2016 Jul 18. PMID 27565938