A Randomized, Double-Blind, Phase 3 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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Eligible male and female patients are required to: (1) have histologically or cytologically confirmed NSCLC, Stage IV based on the AJCC 7th edition; (2) have had disease progression during or after 1and only 1 prior first-line platinum based chemotherapy which may include bevacizumab with or without maintenance therapy for advanced/metastatic disease; (3) be at least 18 years of age; (4) have a life expectancy >=3 months; and (5) have adequate organ function.

Exclusion Criteria

[15] The patient has had disease progression on more than 1 prior chemotherapy regimens (with or without maintenance therapy) for advanced and/or metastatic disease.
[16] Patients whose only prior treatment for advanced disease was a tyrosine kinase inhibitor (for example, erlotinib).
[17] The patient's tumor wholly or partially contains small cell lung cancer.
[18] The patient has undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Furthermore, any patient with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months will be excluded.
[19] The patient has an elective or a planned major surgery during the course of the trial.
[20] The patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy.
• The last dose of bevacizumab must be at least 28 days from the time of randomization.
• The last dose of cytotoxic chemotherapy must be at least 14 days from the time of randomization.
[21] The patient has untreated CNS metastases. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The patient may have no evidence of Grade >=1 CNS hemorrhage based on pretreatment MRI or IV contrast CT scan (performed within 21 days before randomization).
[22] The patient has radiologically documented evidence of major blood vessel invasion or encasement by cancer.
[23] The patient has radiographic evidence of intratumor cavitation, regardless of tumor histology.
[24] The patient has a history of uncontrolled hereditary or acquired thrombotic disorder.
[25] The patient is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents. Patients receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters defined in the inclusion criteria (INR <=1.5, or PT <=1.5 x ULN and PTT/aPTT <=1.5 x ULN) are met.
[26] The patient is receiving chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, and anagrelide). Aspirin use at doses up to 325 mg/day is permitted.
[27] Patients with a history of gross hemoptysis (defined as bright red blood or >=1/2 teaspoon) within 2 months prior to randomization.
[28] The patient has clinically relevant congestive heart failure (NYHA II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
[29] The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
[30] The patient has uncontrolled arterial hypertension >=150 / >=90 mm Hg despite standard medical management.
[31] The patient has had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization.
[32] The

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method