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Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Pemetrexed

Erlotinib

Pemetrexed

Erlotinib

About this trial

This is an interventional prevention trial for Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy. focused on measuring nonsquamous

Eligibility Criteria

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

Inclusion Criteria:

Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.
Failure of previous treatment with one prior platinum-based chemotherapy regimen.
Good performance status.
Adequate bone marrow reserve, renal and hepatic functions.

Exclusion Criteria:

Serious concomitant systemic disease.
Inability to take oral medication.
Inability or unwillingness to take vitamin supplementation and corticosteroids.
Pregnancy / Breast-feeding.
Treatment with certain medicines that prevent blood from clotting.

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Pemetrexed (Nonsquamous)

Pemetrexed + Erlotinib (Nonsquamous)

Pemetrexed (Squamous)

Pemetrexed + Erlotinib (Squamous)

Arm Description

Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm

Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.

Secondary Outcome Measures

Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)

Per RECIST: CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm*100.

Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)

CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm*100.

Time to Treatment Failure (TTTF)

Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than "protocol complete" or "satisfactory response". For participants who discontinued due to "protocol complete" or "satisfactory response", or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date.

Overall Survival (OS)

OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact.

Percentage of Participants Surviving at 1 Year

Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.

Number of Participants With Adverse Events (AEs)

Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.

Full Information

NCT ID

NCT00447057

First Posted

March 9, 2007

Last Updated

September 12, 2011

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00447057

Brief Title

Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

Official Title

A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

June 2011 (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 is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival [PFS], disease control rate, best response rate, time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

6. Conditions and Keywords

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

Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.

Keywords

nonsquamous

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pemetrexed (Nonsquamous)

Arm Type

Experimental

Arm Description

Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm

Arm Title

Pemetrexed + Erlotinib (Nonsquamous)

Arm Type

Experimental

Arm Description

Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm

Arm Title

Pemetrexed (Squamous)

Arm Type

Experimental

Arm Description

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm

Arm Title

Pemetrexed + Erlotinib (Squamous)

Arm Type

Experimental

Arm Description

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

LY231514, Alimta

Intervention Description

500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Other Intervention Name(s)

Tarceva

Intervention Description

150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

LY231514, Alimta

Intervention Description

500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Other Intervention Name(s)

Tarceva

Intervention Description

150 mg given po, QD, starting on the first day of the first cycle

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months

Secondary Outcome Measure Information:

Title

Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)

Description

Time Frame

Baseline to measured PD. Maximum follow-up was from Baseline to 34 months

Title

Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)

Description

Time Frame

Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months

Title

Time to Treatment Failure (TTTF)

Description

Time Frame

Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than "protocol complete" or "satisfactory response". Maximum follow-up was from Baseline to 32.2 months

Title

Overall Survival (OS)

Description

Time Frame

Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.

Title

Percentage of Participants Surviving at 1 Year

Description

Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.

Time Frame

Baseline to date of death from any cause up to 1 year

Title

Number of Participants With Adverse Events (AEs)

Description

Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.

Time Frame

Baseline up to 42.2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy. Failure of previous treatment with one prior platinum-based chemotherapy regimen. Good performance status. Adequate bone marrow reserve, renal and hepatic functions. Exclusion Criteria: Serious concomitant systemic disease. Inability to take oral medication. Inability or unwillingness to take vitamin supplementation and corticosteroids. Pregnancy / Breast-feeding. Treatment with certain medicines that prevent blood from clotting.

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

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

City

Vienna

ZIP/Postal Code

A-1140

Country

Austria

Facility Name

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

City

Gauting

ZIP/Postal Code

82131

Country

Germany

Facility Name

City

Gerlingen

ZIP/Postal Code

70839

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

D 21075

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

City

Immenhausen

ZIP/Postal Code

34376

Country

Germany

Facility Name

City

Trier

ZIP/Postal Code

54219

Country

Germany

Facility Name

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Facility Name

City

Matrahaza

ZIP/Postal Code

3233

Country

Hungary

Facility Name

City

Nyiregyhaza

ZIP/Postal Code

H-4400

Country

Hungary

Facility Name

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

City

Linkoping

ZIP/Postal Code

58185

Country

Sweden

Facility Name

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

City

Solna

ZIP/Postal Code

17176

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

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