Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)

Eli Lilly and Company663 enrolled

Overview

This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in NSCLC. Participants must have received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment) into this trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

663

Conditions

Non-Small Cell Lung Cancer

Interventions

PemetrexedDRUG

500 milligrams per square meter (mg/m\^2), intravenous (IV) administration, every (q) 21 days, until disease progression

PlaceboDRUG

IV administration, q 21 days

Best Supportive CareOTHER

Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or Stage IV prior to induction therapy. * Participants must have had 1 of the following induction therapies for treatment for Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus cisplatin. * Participants must have received only 1 chemotherapeutic doublet lasting precisely 4 cycles. * Induction regimens must be based on 21-day cycles. * Documented evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD). Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the participant to be randomized. Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements for response determination. Exclusion Criteria: * With the exception of those chemotherapies listed as inclusion criterion, participants will not be included if they have received prior systemic anticancer therapy (including adjuvant early-stage treatment for NSCLC) or any systemic treatment for any other cancer. * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * Inability to comply with protocol or study procedures. * A serious concomitant systemic disorder that would compromise the participant's ability to complete the study. * A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.

Locations (73)

Outcomes

Primary Outcomes

Progression-Free Survival (PFS) Time

PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

Time frame: Randomization to measured PD or death from any cause (up to 41 months)

Secondary Outcomes

Overall Survival (OS) Time

OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.

Time frame: Randomization to date of death from any cause (up to 41 months)

Time to Objective Progressive Disease (TPD)

TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant's last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

Time frame: Randomization to measured PD (up to 41 months)

Time to Worsening of Symptoms (TWS)

TWS was the elapsed time from the date of randomization to the first date of worsening \[defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale\] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.

Data from ClinicalTrials.gov

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Minneapolis, Minnesota, United States

Portsmouth, New Hampshire, United States

Pittsburgh, Pennsylvania, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Marshfield, Wisconsin, United States

Bankstown, New South Wales, Australia

Coffs Harbour, New South Wales, Australia

Kogarah, New South Wales, Australia

Port Macquarie, New South Wales, Australia

...and 63 more locations