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A Randomized, Phase 2b, Multi-center Study of Pralatrexate Versus Erlotinib in Patients With Stage IIIB/IV Non-small Cell Lung Cancer After Failure of at Least 1 Prior Platinum-based Treatment

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer

Thank you

Trial Information

A Randomized, Phase 2b, Multi-center Study of Pralatrexate Versus Erlotinib in Patients With Stage IIIB/IV Non-small Cell Lung Cancer After Failure of at Least 1 Prior Platinum-based Treatment

Inclusion Criteria:

- Confirmed Stage IIIB/ IV non-small cell lung cancer (NSCLC).

- Relapsed after treatment with 1 or 2 prior chemotherapy regimens, including at least
1 platinum-based treatment. Patients may have received pemetrexed as 1 of the prior
therapies. Patients may not have received investigational therapy as their only prior

- Recovered from the toxic effects of prior therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Smoked ≥ 100 cigarettes in their lifetime, whether a former or current cigarette

- Adequate blood, liver and kidney function as defined by laboratory values.

- Received 1-1.25 mg daily oral folic acid for at least 7 days prior to randomization
and 1 mg intramuscular injection of vitamin B12 within 10 weeks prior to

- Women of childbearing potential must use medically acceptable birth control and have
a negative serum pregnancy test within 14 days prior to randomization. Patients who
are postmenopausal for at least 1 year (> 12 months since last menses) or are
surgically sterilized do not require this test.

- Men who are not surgically sterile must use medically safe and effective birth
control from the time of study randomization, and agree to continue practicing until
at least 90 days after the last administration of study treatment.

- Accessible for repeat dosing and follow-up.

- Give written informed consent.

Exclusion Criteria:

- Active concurrent primary malignancy (except non-melanoma skin cancer or in situ
carcinoma of the cervix). If there is a history of prior malignancy, the patient must
be disease-free for ≥ 5 years. Patients with other prior malignancies less than 5
years before study entry may still be enrolled if they have received treatment
resulting in complete resolution of the cancer and currently have no evidence of
active or recurrent disease.

- Use of investigational drugs, biologics, or devices within 4 weeks prior to

- Previous exposure to pralatrexate or erlotinib.

- Women who are pregnant or breastfeeding.

- Congestive Heart Failure Class III/IV according to New York Heart Association (NYHA)
Functional Classification.

- Uncontrolled hypertension.

- Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of <100 mm3 or
detectable viral load within the past 3 months, and is receiving combination
anti-retroviral therapy.

- Symptomatic central nervous system metastases or lesions for which treatment is

- Major surgery within 2 weeks of study randomization.

- Receipt of any conventional systemic chemotherapy within 4 weeks (6 weeks for
nitrosoureas, mitomycin C), or radiation therapy (RT) within 2 weeks, prior to

- Active infection or any serious underlying medical condition, which would impair the
ability of the patient to receive protocol treatment.

- Dementia or significantly altered mental status that would prohibit the understanding
and giving of informed consent or limit study compliance.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib

Outcome Description:

OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date.

Outcome Time Frame:

Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.

Safety Issue:


Principal Investigator

Garry Weems, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Spectrum Pharmaceuticals, Inc


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

August 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Stage IIIB/IV non-small cell lung cancer
  • Non-small cell lung cancer
  • Lung Cancer
  • Pralatrexate
  • Erlotinib
  • Tarceva
  • PDX
  • Smoking
  • Smoker
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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