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A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer

Primary Purpose

Non-Small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pemetrexed

Cisplatin

Placebo

Pemetrexed

Best Supportive Care

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for the Induction Phase:

You must sign an informed consent document for clinical research.
You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer.
You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
You are allowed to have had prior radiation therapy as long as it was not to more than 25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must be completed more than 30 days before the study. You must be recovered from the toxic effects (except hair loss).
You must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by computed tomography (CT) Scan.
Your test results assessing the function of your blood forming tissue, kidneys, and liver must be satisfactory.
You must be 18 years of age or older.
Women must be sterile, postmenopausal or on contraception and men must be on contraception or sterile (e.g. post-vasectomy).

Exclusion Criteria for the Induction Phase:

You cannot have squamous cell and/or mixed small cell, non-small cell lung cancer
You cannot have received other investigational drugs within the last 30 days of entering the trial.
You cannot have previously completed or withdrawn from this study or any other study investigating pemetrexed.
You cannot have other serious on-going illnesses including active infections.
You cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial.
You cannot have had another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years. Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years ago.
You cannot have known central nervous system (CNS) metastases, other than treated, stable brain metastasis.
You cannot be receiving nor have received any prior systemic anticancer therapy for lung cancer (including chemotherapy given after surgery in early-stage treatment).
You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).
You cannot have received a recent (within 30 days) or are receiving a yellow fever vaccination.
You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or other non-steroidal anti-inflammatory drugs (NSAIDs).
You are unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids.
You cannot be pregnant or breastfeeding.

Inclusion criteria at Randomization for the Maintenance Phase:

You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
You must have documented radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. 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 patient to be randomized to the maintenance phase.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pemetrexed + cisplatin followed by pemetrexed

pemetrexed + cisplatin followed by placebo

Arm Description

pemetrexed plus cisplatin followed by pemetrexed plus best supportive care

pemetrexed plus cisplatin followed by placebo plus best supportive care

Outcomes

Primary Outcome Measures

Investigator-assessed Objective Progression-free Survival (PFS)

Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

Secondary Outcome Measures

Independently-assessed Objective Progression-free Survival (PFS)

To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

Overall Survival (OS)

OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.

Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score

The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).

Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)

Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).

Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)

Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase

A summary of non-serious AEs is located in the Reported Adverse Event Module.

Percentage of Participants With Serious Adverse Events During Maintenance Phase

A summary of serious adverse events is located in the Reported Adverse Event Module.

Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off

Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.

Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm*100.

Full Information

NCT ID

NCT00789373

First Posted

November 10, 2008

Last Updated

November 20, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00789373

Brief Title

A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer

Official Title

A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment With Pemetrexed + Cisplatin for Advanced Non-squamous Non-Small Cell Lung Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will compare progression-free survival in patients with advanced non-squamous non-small cell lung cancer. Patients who do not progress following 4 cycles of induction treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance pemetrexed or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

939 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pemetrexed + cisplatin followed by pemetrexed

Arm Type

Experimental

Arm Description

pemetrexed plus cisplatin followed by pemetrexed plus best supportive care

Arm Title

pemetrexed + cisplatin followed by placebo

Arm Type

Placebo Comparator

Arm Description

pemetrexed plus cisplatin followed by placebo plus best supportive care

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta, LY231514

Intervention Description

Induction therapy: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Induction therapy: Cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Maintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta, LY231514

Intervention Description

Maintenance therapy: 500 mg/m^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.

Intervention Type

Other

Intervention Name(s)

Best Supportive Care

Intervention Description

Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).

Primary Outcome Measure Information:

Title

Investigator-assessed Objective Progression-free Survival (PFS)

Description

Time Frame

Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)

Secondary Outcome Measure Information:

Title

Independently-assessed Objective Progression-free Survival (PFS)

Description

Time Frame

Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)

Title

Overall Survival (OS)

Description

OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.

Time Frame

Date of randomization to the date of death from any cause up to 39.5 months

Title

Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score

Description

Time Frame

Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

Title

Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)

Description

Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).

Time Frame

Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

Title

Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)

Time Frame

Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

Title

Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase

Description

A summary of non-serious AEs is located in the Reported Adverse Event Module.

Time Frame

Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)

Title

Percentage of Participants With Serious Adverse Events During Maintenance Phase

Description

A summary of serious adverse events is located in the Reported Adverse Event Module.

Time Frame

Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)

Title

Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off

Description

Time Frame

Baseline to date of measured progressive disease (up to 19.3 months)

Title

Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off

Description

Time Frame

Date of randomization to date of measured PD (up to 19.3 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for the Induction Phase: You must sign an informed consent document for clinical research. You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer. You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work. You are allowed to have had prior radiation therapy as long as it was not to more than 25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must be completed more than 30 days before the study. You must be recovered from the toxic effects (except hair loss). You must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by computed tomography (CT) Scan. Your test results assessing the function of your blood forming tissue, kidneys, and liver must be satisfactory. You must be 18 years of age or older. Women must be sterile, postmenopausal or on contraception and men must be on contraception or sterile (e.g. post-vasectomy). Exclusion Criteria for the Induction Phase: You cannot have squamous cell and/or mixed small cell, non-small cell lung cancer You cannot have received other investigational drugs within the last 30 days of entering the trial. You cannot have previously completed or withdrawn from this study or any other study investigating pemetrexed. You cannot have other serious on-going illnesses including active infections. You cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial. You cannot have had another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years. Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years ago. You cannot have known central nervous system (CNS) metastases, other than treated, stable brain metastasis. You cannot be receiving nor have received any prior systemic anticancer therapy for lung cancer (including chemotherapy given after surgery in early-stage treatment). You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures). You cannot have received a recent (within 30 days) or are receiving a yellow fever vaccination. You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or other non-steroidal anti-inflammatory drugs (NSAIDs). You are unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids. You cannot be pregnant or breastfeeding. Inclusion criteria at Randomization for the Maintenance Phase: You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work. You must have documented radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. 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 patient to be randomized to the maintenance phase.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

City

Frankston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

City

Wendouree

State/Province

Victoria

ZIP/Postal Code

3355

Country

Australia

Facility Name

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

City

Sint Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

City

Espoo

ZIP/Postal Code

02740

Country

Finland

Facility Name

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

City

Avignon

ZIP/Postal Code

84082

Country

France

Facility Name

City

Dijon

ZIP/Postal Code

21034

Country

France

Facility Name

City

Le Mans Cedex 1

ZIP/Postal Code

72037

Country

France

Facility Name

City

Montpellier

ZIP/Postal Code

F-34295

Country

France

Facility Name

City

Nantes

ZIP/Postal Code

44202

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

City

Vandoeuvre-Les-Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

City

Gerlingen

ZIP/Postal Code

70839

Country

Germany

Facility Name

City

Großhansdorf

ZIP/Postal Code

D-22927

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

D-20251

Country

Germany

Facility Name

City

Heidelberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

City

Athens

Country

Greece

Facility Name

City

Chania

ZIP/Postal Code

73300

Country

Greece

Facility Name

City

Neo Faliro

ZIP/Postal Code

18547

Country

Greece

Facility Name

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

City

Bangalore

ZIP/Postal Code

560 078

Country

India

Facility Name

City

Bhopal

ZIP/Postal Code

462001

Country

India

Facility Name

City

Madurai

ZIP/Postal Code

625020

Country

India

Facility Name

City

Mumbai

ZIP/Postal Code

400 012

Country

India

Facility Name

City

Patna

ZIP/Postal Code

800 014

Country

India

Facility Name

City

Avellino

ZIP/Postal Code

83100

Country

Italy

Facility Name

City

Aviano

ZIP/Postal Code

33081

Country

Italy

Facility Name

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

City

Lido Di Camaiore

ZIP/Postal Code

55043

Country

Italy

Facility Name

City

Monza

ZIP/Postal Code

20052

Country

Italy

Facility Name

City

Pisa

ZIP/Postal Code

56100

Country

Italy

Facility Name

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00149

Country

Italy

Facility Name

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

City

Ede

ZIP/Postal Code

6716 RP

Country

Netherlands

Facility Name

City

Groningen

ZIP/Postal Code

9728 NT

Country

Netherlands

Facility Name

City

Harderwijk

ZIP/Postal Code

3844 DG

Country

Netherlands

Facility Name

City

Heerlen

ZIP/Postal Code

6419 PC

Country

Netherlands

Facility Name

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-781

Country

Poland

Facility Name

City

Coimbra

ZIP/Postal Code

3040-853

Country

Portugal

Facility Name

City

Lisbon

ZIP/Postal Code

1099-035

Country

Portugal

Facility Name

City

Vila Franca De Xira

ZIP/Postal Code

4434-502

Country

Portugal

Facility Name

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

3400

Country

Romania

Facility Name

City

Oradea

ZIP/Postal Code

3700

Country

Romania

Facility Name

City

Manresa

ZIP/Postal Code

308243

Country

Spain

Facility Name

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

City

Bornova

ZIP/Postal Code

35100

Country

Turkey

Facility Name

City

Sihhiye

ZIP/Postal Code

06100

Country

Turkey

Facility Name

City

Zeytinburnu

ZIP/Postal Code

034760

Country

Turkey

Facility Name

City

Aberdeen

State/Province

Scotland

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

City

Guildford

State/Province

Surrey

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

City

Newcastle

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29424248

Citation

Middleton G, Gridelli C, De Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Visseren-Grul CM, San Antonio B, John WJ, Zimmermann AH, Chouaki N, Paz-Ares L. Evaluation of changes in renal function in PARAMOUNT: a phase III study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Curr Med Res Opin. 2018 May;34(5):865-871. doi: 10.1080/03007995.2018.1439462. Epub 2018 Mar 27.

Results Reference

derived

PubMed Identifier

25104617

Citation

Pujol JL, Paz-Ares L, de Marinis F, Dediu M, Thomas M, Bidoli P, Corral J, San Antonio B, Chouaki N, John W, Zimmermann A, Visseren-Grul C, Gridelli C. Long-term and low-grade safety results of a phase III study (PARAMOUNT): maintenance pemetrexed plus best supportive care versus placebo plus best supportive care immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2014 Nov;15(6):418-25. doi: 10.1016/j.cllc.2014.06.007. Epub 2014 Jun 21.

Results Reference

derived

PubMed Identifier

24419418

Citation

Reck M, Paz-Ares LG, de Marinis F, Molinier O, Sahoo TP, Laack E, John W, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Descriptive subgroup analyses of final overall survival for the phase III study of maintenance pemetrexed versus placebo following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2014 Feb;9(2):205-13. doi: 10.1097/JTO.0000000000000076.

Results Reference

derived

PubMed Identifier

23835707

Citation

Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.

Results Reference

derived

PubMed Identifier

23328269

Citation

Zeng X, Peng L, Li J, Chen G, Tan C, Wang S, Wan X, Ouyang L, Zhao Z. Cost-effectiveness of continuation maintenance pemetrexed after cisplatin and pemetrexed chemotherapy for advanced nonsquamous non-small-cell lung cancer: estimates from the perspective of the Chinese health care system. Clin Ther. 2013 Jan;35(1):54-65. doi: 10.1016/j.clinthera.2012.12.013.

Results Reference

derived

PubMed Identifier

23059776

Citation

Gridelli C, de Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Middleton G, Corral J, Winfree K, Melemed S, Zimmermann A, John W, Beyrer J, Chouaki N, Visseren-Grul C, Paz-Ares LG. Safety, resource use, and quality of life in paramount: a phase III study of maintenance pemetrexed versus placebo after induction pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2012 Nov;7(11):1713-21. doi: 10.1097/JTO.0b013e318267cf84.

Results Reference

derived

PubMed Identifier

22341744

Citation

Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.

Results Reference

derived

PubMed Identifier

20211022

Citation

Paz-Ares LG, Altug S, Vaury AT, Jaime JC, Russo F, Visseren-Grul C. Treatment rationale and study design for a phase III, double-blind, placebo-controlled study of maintenance pemetrexed plus best supportive care versus best supportive care immediately following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer. BMC Cancer. 2010 Mar 8;10:85. doi: 10.1186/1471-2407-10-85.

Results Reference

derived

Learn more about this trial

A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer

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