Conditions

nonsquamous

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

Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)
Baseline to measured PD. Maximum follow-up was from Baseline to 34 months
Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)
Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months
Time to Treatment Failure (TTTF)
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
Overall Survival (OS)
Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.
Percentage of Participants Surviving at 1 Year
Baseline to date of death from any cause up to 1 year
+1 more secondary outcomes

EXPERIMENTAL

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

Drug: Pemetrexed

EXPERIMENTAL

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

Drug: ErlotinibDrug: Pemetrexed

EXPERIMENTAL

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

Drug: Pemetrexed

EXPERIMENTAL

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

Drug: PemetrexedDrug: Erlotinib

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

Also known as: LY231514, Alimta

Pemetrexed (Nonsquamous)

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

Also known as: Tarceva

Pemetrexed + Erlotinib (Nonsquamous)

Age18 Years+

Sexall

Healthy VolunteersNo

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

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.

Contact the study team to confirm eligibility.