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A Phase 2 Study of Pemetrexed and Cisplatin Plus Cetuximab Followed by Pemetrexed and Cetuximab Maintenance Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB or IV) Other Than Predominantly Squamous Cell Histology

Phase 2
18 Years
Open (Enrolling)
Non-Small-Cell Lung Cancer

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Trial Information

A Phase 2 Study of Pemetrexed and Cisplatin Plus Cetuximab Followed by Pemetrexed and Cetuximab Maintenance Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB or IV) Other Than Predominantly Squamous Cell Histology

Inclusion Criteria:

- Patient must sign an informed consent document for clinical and translational

- Patient must have locally advanced or metastatic nonsquamous Non-Small Cell Lung

- Patient must have biological tissue available from your diagnosis tumor for detection
of some biomarkers (translational research).

- Patient cannot be receiving nor have received any prior systemic anticancer therapy,
immunotherapy, targeted therapy, or biological therapy for your lung cancer (except
chemotherapy given after surgery if it has been completed more than one year before
the study entry).

- Patient is allowed to have had prior radiation therapy as long as it was not more
than 25% of the bone marrow and did not include the whole pelvis. Prior radiation
therapy should be completed at least 2 weeks prior to first study drug. Thoracic
radiation must be completed more than 12 weeks before the study entry. You must be
recovered from the toxic effects.

- Patient must have at least 1 measurable tumor lesion according to the Response
Evaluation Criteria in Solid Tumors (RECIST) guidelines.

- Patient 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.

- Test results assessing the function of blood forming tissue, kidneys, and liver must
be satisfactory.

- Females must be sterile, postmenopausal or on contraception.

- Males must be on contraception or sterile (for example post-vasectomy).

Exclusion Criteria:

- Patient cannot have symptomatic central nervous system metastases.

- Patient cannot have an active infection or other serious condition that your doctor
thinks would make you unable to participate.

- Patient cannot have a serious cardiac condition, such as a heart attack, angina, or
heart disease within 6 months of entering the trial.

- Patient cannot have had a 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.

- Patient cannot have had significant neurologic or psychiatric disorders including
dementia, seizures and bipolar disorder.

- Patient cannot have moderate or severe peripheral neuropathy

- Patient cannot have received treatment within 30 days with any experimental drug.

- Patient cannot have had a major surgery within the last 4 weeks.

- Patient cannot have previously received treatment with transduction inhibitors or
Epidermal Growth Factor Receptor (EGFR)-targeting therapy.

- Patient cannot have prior known allergic/hypersensitivity reaction to any of the
components of study treatments.

- Females cannot be pregnant or breastfeeding.

- Patient is unable to stop taking more than 1.3 grams of aspirin on a daily basis or
other aspirin like medication (non-steroidal antiinflammatory drugs: NSAIDs) for a
few days during each cycle of therapy.

- Patient is unable or unwilling to take folic acid, injections of vitamin B12, or

- Patient cannot have fluid around your lungs or in your abdomen (pleural effusions or
ascites) that cannot be controlled by drainage or other procedures.

- Patient cannot have received a yellow fever vaccination within the previous 30 days
or plan to have it.

- Patient cannot have known drug abuse.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With a Tumor Response (Objective Tumor Response Rate)

Outcome Description:

Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions. Tumor response is presented as a percentage (%) and is the number of participants with a CR plus PR divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100.

Outcome Time Frame:

From start of treatment until documented best response. (up to 18.9 months)

Safety Issue:


Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


Austria: Federal Office for Safety in Health Care

Study ID:




Start Date:

April 2009

Completion Date:

October 2013

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms