A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer

Eli Lilly and Company197 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

197

Conditions

Non-small Cell Lung Cancer Metastatic

Interventions

RamucirumabDRUG

Administered IV

PlaceboDRUG

Administered IV

DocetaxelDRUG

Administered IV

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (15)

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

PFS was defined as the time from baseline until measured progressive disease (PD) or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.

Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (Up to 21 Months)

Secondary Outcomes

Overall Survival (OS)

OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.

Time frame: Baseline to Death from Any Cause (Up to 28 Months)

Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)]

Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal \[ULN\]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. The percentage of participants who achieved an objective response equals (number of participants with CR or PR)/(number of participants assessed)\*100.

Data from ClinicalTrials.gov

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Aichi, Japan

Chiba, Japan

Ehime, Japan

Fukuoka, Japan

Hokkaido, Japan

Hyōgo, Japan

Ishikawa, Japan

Kanagawa, Japan

Miyagi, Japan

Okayama, Japan

...and 5 more locations

Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]

Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal \[ULN\]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)\*100.

Time frame: Baseline to Measured Progressive Disease or Participant Stopped Study (Up to 97 Weeks)