Phase 3 N=260 Randomized Treatment

Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00520676 ↗

Enrolled (actual)

260

Serious AEs

29.9%

Results posted

Jul 2011

Primary outcome: Primary: Survival Without Grade 3 or 4 Toxicity — 3.2; 0.7 months — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: pemetrexed (Drug); docetaxel (Drug); carboplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Survival Without Grade 3 or 4 Toxicity	3.2; 0.7	<0.001 sig
SECONDARY Overall Survival (OS)	14.9; 14.7	0.934
SECONDARY Progression-free Survival (PFS)	5.8; 6.0	0.800
SECONDARY Percentage of Participants With Tumor Response (Response Rate)	34.0; 23.1; 74.5; 64.4; 0.9; 0	0.081
SECONDARY Survival Without Clinically Important Grade 3 or 4 Toxicity	3.6; 1.3	<0.001 sig
SECONDARY Survival Without Grade 4 Toxicity	12.2; 2.0	<0.001 sig
SECONDARY Number of Participants With Adverse Events (AEs)	94; 100; 28; 35	—

Summary

The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00520676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.