Conditions

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.
Randomization to measured PD up to 38 months

Secondary Outcomes (7)

Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]
Randomization to measured disease progression up to 38 months
Overall Survival (OS)
Baseline to date of death from any cause up to 45.5 months
Number of Participants With Adverse Events
Randomization up to 39 months
Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)
Randomization to disease progression up to 38 months
Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)
Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months
+2 more secondary outcomes

Study Arms (3)

Pemetrexed + Erlotinib

EXPERIMENTAL

Pemetrexed 500 milligrams per meter squared (mg/m\^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.

Drug: pemetrexedDrug: erlotinib

Erlotinib

ACTIVE COMPARATOR

Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.

Drug: erlotinib

Pemetrexed

ACTIVE COMPARATOR

Pemetrexed 500 mg/m\^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.

Drug: pemetrexed

Interventions

pemetrexedDRUG

500 milligrams per meter squared (mg/m\^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops

Also known as: LY231514, Alimta

PemetrexedPemetrexed + Erlotinib

erlotinibDRUG

150 mg, orally, once daily until progression or unacceptable toxicity develops

ErlotinibPemetrexed + Erlotinib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
Patients must be non-smokers
Patients must have at least one measurable lesion
Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale
Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.

You may not qualify if:

Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Patients who have previously received treatment with drugs against the human epidermal growth factor receptors
Patients who have previously received treatment with drugs which have similar targets as Pemetrexed
Patients who have any known significant ophthalmologic abnormalities of the surface of the eye
Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed

Contact the study team to confirm eligibility.