Back to results

Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pemetrexed

Cetuximab

Docetaxel

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Recurrent or Progressive Non-Small Cell Lung Cancer, Second-line therapy, Docetaxel, Pemetrexed, Cetuximab, Failed platinum-based therapy, NSCLC

Eligibility Criteria

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

Inclusion Criteria: Pathologic confirmation of metastatic, unresectable, or locally-advanced NSCLC. Disease progression during or following one prior platinum-based chemotherapy regimen for advanced disease (stage IIIB or IV). Bidimensionally measurable disease. Karnofsky performance status score of 60 to 100 at study entry. The participant has tumor tissue available for immunohistochemical determination of epidermal growth factor (EGFR) expression. Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 4 weeks must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent, or prior radiation therapy (palliative radiation therapy is allowed). Accessible for treatment and follow-up. Participants enrolled in this trial must be treated at the participating center. Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception. WOCBP must have a negative serum or urine pregnancy test. Exclusion Criteria: Women who are pregnant or breastfeeding. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy. Symptomatic or uncontrolled metastases in the brain. Participants receiving a glucocorticoid for brain metastases will be excluded, but those receiving anticonvulsants will be eligible. Uncontrolled pleural effusion or ascites. Peripheral neuropathy greater than grade 2, as assessed by the National Cancer Institutes-Common Toxicity Criteria Adverse Events (NCI-CTCAE), Version 3.0. Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy, but without evidence of disease for greater than or equal 3 years will be allowed to enter the trial. More than one prior chemotherapy regimen for advanced disease. Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm3, a platelet count <100,000/mm3, and a hemoglobin level <9 g/dL. Red blood cell transfusions are not permitted within 7 days of receiving cetuximab, docetaxel, or pemetrexed. Inadequate hepatic function, defined by a total bilirubin level >1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) levels >2.5 times the ULN (greater than or equal to 5 times the ULN if known liver metastases), and an alkaline phosphatase level >5.0 times the ULN. Inadequate renal function defined by a serum creatinine level >1.5 times the ULN. Prior treatment with cetuximab, or any other epidermal growth factor receptor inhibitors, including tyrosine kinase inhibitors, such as gefitinib or erlotinib. Participants must not have received prior chimerized or murine monoclonal antibody therapy. Prior treatment with other monoclonal antibodies targeting receptors other than the EGFR is permitted >30 days prior to randomization. Prior treatment with docetaxel or pemetrexed therapy. Inability or unwillingness to take folic acid or vitamin B12 supplementation. Inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long-acting agents such as piroxicam). Aspirin will be permitted during the study. Patients (including prisoners) who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness. Prior treatment with an experimental drug or medical device within 30 days of randomization.

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Cetuximab & Pemetrexed

Pemetrexed

Cetuximab & Docetaxel

Docetaxel

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

PFS was defined as the time from randomization until the date of progressive disease (PD) or death from any cause. Participants who were alive and without progression were censored at the date of their last tumor assessment. PFS was assessed by the independent review committee (IRC) in the Pemetrexed group (Cetuximab & Pemetrexed versus Pemetrexed) and by the investigator in the Docetaxel group (Cetuximab & Docetaxel versus Docetaxel).

Secondary Outcome Measures

Overall Survival (OS)

OS was defined as the time from randomization to death. Participants without a date of death were censored on the last date participants were known to be alive, or lost to follow-up.

Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])

The best overall response rate (ORR) was the proportion of randomized participants with a best OR of CR or PR, according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR or PR divided by the total number of participants treated in that arm. Participants with no post-baseline evaluation were considered as non-responders. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.

Proportion of Randomized Participants With Best Overall Response (OR) of Partial Response (PR), Complete Response (CR), or Stable Disease (SD)

The disease control rate (DCR) was the proportion of randomized participants with a best OR of CR, PR or SD according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR, PR or SD divided by the total number of participants randomized in that arm. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.

Percentage of Participants With Symptomatic Response (Symptom Response Rates) Using the Lung Cancer Subscale (LCS) Scores of Functional Assessment of Cancer Therapy for Participants With Lung Cancer (FACT-L)

The FACT-LCS is a set of 7 questions to inventory problems specific to lung cancer symptoms. Participants rate each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). Scores range from 0-28 and higher score indicates fewer symptoms. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item LCS score that was maintained for 2 consecutive assessments at least 3 weeks, and not >5 weeks apart for participants, whose baseline LCS score was ≤26. Symptom response rate was the percentage of participants with symptomatic response.

Time to Symptomatic Progression

The FACT-LCS (see description in Outcome measure 5) inventories problems specific to lung cancer symptoms. Using this Scale, Symptom progression = a ≥ 2 point decrease from baseline in LCS score maintained for 2 consecutive assessments ≥3 weeks, and <5 weeks, apart. The symptom progression date = the first of 2 consecutive assessments with a ≥2 point decline. Time to symptomatic progression = the time from randomization to the symptom progression date. For participants with no symptom progression, time to symptomatic progression was censored the date of last symptom assessment.

Duration of Overall Response (OR)

The duration of response, in participants with best OR of complete response (CR) or partial response (PR), was measured from the date criteria are met for CR/PR (not confirmation date, whichever was first recorded), until the first occurrence date that the criteria of progressive disease (PD) was met, or death. Participants who were alive and without progression were censored at the date of their last independent review committee (IRC) tumor assessment. The tumor response and progression were assessed by the IRC in the Pemetrexed group and by the investigator in the Docetaxel group.

Number of Participants With Common Toxicity Criteria (CTC) Grade 3 or 4 Toxicities

National Cancer Institutes-Common Toxicity Criteria version 3.0 was used by investigators to assess participant toxicities. Mapping of investigator verbatim terms to CTCAE terms was done by the sponsor/designee using CTCAE v4.0. Participants reported had grade 3 or 4 toxicities (or both potentially). Grade 3 AEs: severe or medically significant but not immediately life-threatening;hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 AEs: life-threatening consequences; urgent intervention indicated.

Full Information

NCT ID

NCT00095199

First Posted

November 1, 2004

Last Updated

September 13, 2012

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00095199

Brief Title

Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer

Official Title

Randomized Phase III Study of Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer After Platinum-Based Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice. Within each chemotherapy group, patients will be randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab & Pemetrexed or Pemetrexed alone; Cetuximab & Docetaxel or Docetaxel alone).

6. Conditions and Keywords

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

Non Small Cell Lung Cancer

Keywords

Recurrent or Progressive Non-Small Cell Lung Cancer, Second-line therapy, Docetaxel, Pemetrexed, Cetuximab, Failed platinum-based therapy, NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

939 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cetuximab & Pemetrexed

Arm Type

Experimental

Arm Title

Pemetrexed

Arm Type

Active Comparator

Arm Title

Cetuximab & Docetaxel

Arm Type

Experimental

Arm Title

Docetaxel

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta, LY231514

Intervention Description

Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.

Intervention Type

Biological

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux, LY2939777

Intervention Description

Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity.

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Randomization to progression of disease or death due to any cause up to 59.6 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS was defined as the time from randomization to death. Participants without a date of death were censored on the last date participants were known to be alive, or lost to follow-up.

Time Frame

Randomization to the date of death from any cause up to 72.8 months

Title

Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])

Description

Time Frame

Randomization until progression of disease or death from any cause up to 59.6 months

Title

Proportion of Randomized Participants With Best Overall Response (OR) of Partial Response (PR), Complete Response (CR), or Stable Disease (SD)

Description

Time Frame

Randomization to progression of disease or death due to any cause up to 59.6 months

Title

Description

Time Frame

At baseline, every 3 weeks and 30 days after end of therapy up to 50 months

Title

Time to Symptomatic Progression

Description

Time Frame

Randomization until symptomatic progression up to 48.3 months

Title

Duration of Overall Response (OR)

Description

Time Frame

Time of first occurrence of either (PR) or (CR) to the first date of progressive disease or death up to 32.5 months

Title

Number of Participants With Common Toxicity Criteria (CTC) Grade 3 or 4 Toxicities

Description

Time Frame

Time from first dose to 30 days after last dose of study therapy up to 28.3 months for Cetuximab & Pemetrexed (versus Pemetrexed alone) and up to 54.3 months for Cetuximab + Docetaxel (versus Docetaxel alone)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36106

Country

United States

Facility Name

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85012

Country

United States

Facility Name

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

City

Tuscon

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902

Country

United States

Facility Name

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33461

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30341

Country

United States

Facility Name

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30901

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60674

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46227

Country

United States

Facility Name

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21701

Country

United States

Facility Name

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49048

Country

United States

Facility Name

City

Mount Clemens

State/Province

Michigan

ZIP/Postal Code

48043

Country

United States

Facility Name

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

City

St Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

City

St Joseph

State/Province

Missouri

ZIP/Postal Code

64507

Country

United States

Facility Name

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

City

Cherry Hill

State/Province

New Jersey

ZIP/Postal Code

08003

Country

United States

Facility Name

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Facility Name

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

City

Concord

State/Province

North Carolina

ZIP/Postal Code

28025

Country

United States

Facility Name

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

City

Dunmore

State/Province

Pennsylvania

ZIP/Postal Code

18512

Country

United States

Facility Name

City

Kingston

State/Province

Pennsylvania

ZIP/Postal Code

18704

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19114

Country

United States

Facility Name

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

City

Hilton Head Island

State/Province

South Carolina

ZIP/Postal Code

29926

Country

United States

Facility Name

City

Mt. Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

City

Grapevine

State/Province

Texas

ZIP/Postal Code

76051

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

City

Colchester

State/Province

Vermont

ZIP/Postal Code

05446

Country

United States

Facility Name

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Facility Name

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98684

Country

United States

Facility Name

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

City

St-Jerome

State/Province

Quebec

ZIP/Postal Code

J7Z 5T3

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24231627

Citation

Kim ES, Neubauer M, Cohn A, Schwartzberg L, Garbo L, Caton J, Robert F, Reynolds C, Katz T, Chittoor S, Simms L, Saxman S. Docetaxel or pemetrexed with or without cetuximab in recurrent or progressive non-small-cell lung cancer after platinum-based therapy: a phase 3, open-label, randomised trial. Lancet Oncol. 2013 Dec;14(13):1326-36. doi: 10.1016/S1470-2045(13)70473-X. Epub 2013 Nov 12. Erratum In: Lancet Oncol. 2014 Jan;15(1):e4.

Results Reference

derived

Learn more about this trial

Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer

We'll reach out to this number within 24 hrs