NCT00102804 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2014-12-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-Free Survival (PFS) Time

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outcome · POSTED

Overall Survival (OS) Time

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outcome · POSTED

Time to Objective Progressive Disease (TPD)

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outcome · POSTED

Time to Worsening of Symptoms (TWS)

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outcome · POSTED

Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)

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outcome · POSTED

Number of Participants With Adverse Events (AEs)

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outcome · POSTED

Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: Pemetrexed
Other: Best Supportive Care
label
Pemetrexed and Best Supportive Care
type
EXPERIMENTAL
intervention Names
Drug: Placebo
Other: Best Supportive Care
label
Placebo and Best Supportive Care
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Pemetrexed and Best Supportive Care
description
500 milligrams per square meter (mg/m\^2), intravenous (IV) administration, every (q) 21 days, until disease progression
name
Pemetrexed
other Names
LY231514
Alimta
type
DRUG
arm Group Labels
Placebo and Best Supportive Care
description
IV administration, q 21 days
name
Placebo
type
DRUG
arm Group Labels
Pemetrexed and Best Supportive Care
Placebo and Best Supportive Care
description
Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
name
Best Supportive Care
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 663
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Progression-Free Survival (PFS) Time
time Frame
Randomization to measured PD or death from any cause (up to 41 months)

secondary Outcomes

description
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.
measure
Overall Survival (OS) Time
time Frame
Randomization to date of death from any cause (up to 41 months)
description
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.
measure
Time to Objective Progressive Disease (TPD)
time Frame
Randomization to measured PD (up to 41 months)
description
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.
measure
Time to Worsening of Symptoms (TWS)
time Frame
Randomization to worsening of each LCSS item (up to 39 months)
description
Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)\*100.
measure
Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)
time Frame
Baseline to measured PD (up to 41 months)
description
Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
measure
Number of Participants With Adverse Events (AEs)
time Frame
Baseline to study completion (up to 41 Months)
description
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 responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.
measure
Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS
time Frame
Baseline through 30 days post discontinuation of study treatment (up to 39 Months)

Full study description

brief Summary: 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.

Source references

references

citation
Belani CP, Brodowicz T, Ciuleanu TE, Krzakowski M, Yang SH, Franke F, Cucevic B, Madhavan J, Santoro A, Ramlau R, Liepa AM, Visseren-Grul C, Peterson P, John WJ, Zielinski CC. Quality of life in patients with advanced non-small-cell lung cancer given maintenance treatment with pemetrexed versus placebo (H3E-MC-JMEN): results from a randomised, double-blind, phase 3 study. Lancet Oncol. 2012 Mar;13(3):292-9. doi: 10.1016/S1470-2045(11)70339-4. Epub 2012 Feb 14.
pmid
22336221
type
DERIVED
citation
Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.
pmid
22266043
type
DERIVED
citation
Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009 Oct 24;374(9699):1432-40. doi: 10.1016/S0140-6736(09)61497-5. Epub 2009 Sep 18.
pmid
19767093
type
DERIVED