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

NCT01703091 | Completed Phase 2 Results

• 2 other identifiers: 14658I4T-JE-JVCG
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 15

Brief Summary

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

Non-small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

• Overall Survival (OS)

  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)]

  Baseline to Measured Progressive Disease or Participant Stops Study (Up to 97 Weeks)

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

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

• Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score

  Baseline, Day 21 Each Cycle (Cycle = 21 Days) and 30-Day Follow Up (Up to 97 Weeks)

• Change From Baseline in Lung Cancer Symptom Scale (LCSS)

  Baseline to Measured Progressive Disease or Participant Stopped Study (up to 97 weeks)

Study Arms (2)

Ramucirumab plus Docetaxel

EXPERIMENTAL

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.

Drug: Ramucirumab; Drug: Docetaxel

Placebo plus Docetaxel

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Docetaxel

Interventions

Ramucirumab DRUG

Administered IV

Also known as: LY 3009806, IMC-1121B, Cyramza®

Ramucirumab plus Docetaxel

Placebo DRUG

Administered IV

Placebo plus Docetaxel

Docetaxel DRUG

Administered IV

Placebo plus Docetaxel; Ramucirumab plus Docetaxel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (15)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Aichi, 464-8681, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Chiba, 277 8577, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ehime, 791-0280, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fukuoka, 830-0011, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hokkaido, 060-8648, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hyōgo, 673-8558, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ishikawa, 920-8641, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kanagawa, 236-0051, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Miyagi, 980-8574, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Okayama, 700-8558, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Osaka, 589-8511, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Saitama, 362-0806, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Shizuoka, 411-8777, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tokyo, 135-8550, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Yamaguchi, 755-0241, Japan

Location

Related Publications (2)

• Mitani 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 DERIVED

• Yoh 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 DERIVED

MeSH Terms

Interventions

Ramucirumab; Docetaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2016
• Last Updated: September 30, 2019
• Results First Posted: January 20, 2016

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

JP (15)