Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Survival Without Grade 3 or 4 Toxicity
Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

Secondary Outcomes (6)

Overall Survival (OS)
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Progression-free Survival (PFS)
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Percentage of Participants With Tumor Response (Response Rate)
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Survival Without Clinically Important Grade 3 or 4 Toxicity
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Survival Without Grade 4 Toxicity
Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).
+1 more secondary outcomes

Other Outcomes (1)

Duration of Response
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

Study Arms (2)

pemetrexed plus carboplatin

EXPERIMENTAL

Drug: pemetrexed 500 milligrams per square meter (mg/m\^2), intravenous (IV), every (q) 21 days x 6 cycles maximum Drug: carboplatin Area Under the Curve (AUC) 5 milligram\*minute/milliLiter (mg\*min/mL), IV, q 21 days x 6 cycles maximum

Drug: pemetrexedDrug: carboplatin

docetaxel plus carboplatin

ACTIVE COMPARATOR

Drug: docetaxel 75 mg/m\^2, IV, q 21 days x 6 cycles maximum Drug: carboplatin AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum

Drug: docetaxelDrug: carboplatin

Interventions

pemetrexedDRUG

500 mg/m\^2, IV, q 21 days x 6 cycles maximum

Also known as: LY231514, Alimta

pemetrexed plus carboplatin

docetaxelDRUG

75 mg/m\^2, IV, q 21 days x 6 cycles maximum

docetaxel plus carboplatin

carboplatinDRUG

AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum

docetaxel plus carboplatinpemetrexed plus carboplatin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment
Easter Cooperative Oncology Group (ECOG) performance status 0 to 2
Estimated life expectancy of at least 8 weeks

You may not qualify if:

Known or suspected brain metastases
Concurrent administration of any other tumor therapy
Serious concomitant disorders
Pregnancy or breast feeding
Inability or unwillingness to take folic acid or vitamin B12 supplementation

Contact the study team to confirm eligibility.