Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

1 Year Progression Free Survival
Progression free survival (PFS) was defined as the time from study enrollment to the first observation of progressive disease (PD) or death from any cause. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study drug) prior to objectively determined PD or death, PFS was censored at the date of the last objective progression-free disease assessment prior to start of postdiscontinuation chemotherapy. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.
Date of first dose to date of objectively determined PD or death [every cycle up to 4 cycles and then every 3 months up to 1 year (1 cycle=21 days)]

Secondary Outcomes (2)

Overall Survival
Date of first dose to date of death (up to 35.4 months)
Number of Participants With an Objective Tumor Response
Date of first dose through end of follow-up [up to 30 weeks (1 cycle=21 days)]

Study Arms (1)

Pemetrexed

EXPERIMENTAL

Pemetrexed and cisplatin are given as induction therapy followed after by pemetrexed and cisplatin with concurrent radiotherapy.

Drug: PemetrexedDrug: CisplatinRadiation: Thoracic Radiotherapy

Interventions

PemetrexedDRUG

500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of a 21 day cycle for 2 cycles: with possibility of 2 additional cycles.

Also known as: Alimta, LY231514

Pemetrexed

CisplatinDRUG

75 mg/m² intravenous infusion on Day 1 of a 21 day cycle for 2 cycles; with the possibility of 2 additional cycles.

Pemetrexed

Thoracic RadiotherapyRADIATION

Administered at 2 gray (Gy)/fraction after completion of the pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and will continue daily (5 days per week) until the total delivered dose reaches a therapeutic goal of 66 Gy, over approximately 7 weeks.

Pemetrexed

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Histologic or cytologic diagnosis of unresectable nonsquamous Stage IIIA or Stage IIIB (without malignant pleural/pericardial effusions) NSCLC.
Have an ECOG performance status of 0 or 1.
Previous radiation therapy should have been limited and must not have included thoracic radiation, whole pelvis radiation, or radiation to \>25% of the participant's bone marrow, participants must have recovered from the toxic effects of radiation treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry.
Have at least 1 unidimensionally measurable lesion meeting RECIST guidelines, version 1.0.
Estimated life expectancy of at least 12 weeks.
Participant compliance and geographic proximity that allow adequate follow-up.
Adequate bone marrow reserve, hepatic-, renal- and pulmonary function.
Participants must sign an Informed Consent Document.
Participants must have a total lung V20 less than or equal to 35%.
For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen, during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
Have not received prior systemic anticancer therapy for NSCLC.

You may not qualify if:

Have received treatment within the last 30 days of enrollment with a drug that has not received regulatory approval for any indication at the time of study entry.
Have previously completed or withdrawn from this study or any other study investigating pemetrexed.
Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.
Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Participants with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
Are receiving concurrent administration of any other antitumor therapy.
Have had weight loss of more than 10% over the previous 3 months before study entry.
Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose less than or equal to 1.3 grams per day, for at least 2 days before (5 days for long-acting agents), the day of, and for at least 2 days after administration of pemetrexed.
Are unable or unwilling to take folic acid or vitamin B12 supplementation.
Are unable or unwilling to take corticosteroids.
Have received a recent yellow fever vaccination (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination.
Have known hypersensitivity to pemetrexed, cisplatin, or any of the excipients in these medicinal products.
Have evidence of clinical hearing loss.
Have clinically significant third-space fluid collections, that cannot be controlled by drainage or other procedures prior to study entry.

Contact the study team to confirm eligibility.