Phase 2
N=122
Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00269152 ↗Enrolled (actual)
122
Serious AEs
19.5%
Results posted
Jun 2009
Primary outcome: Primary: The Feasibility of Post-Surgery Chemotherapy — 38; 27; 18; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pemetrexed (Drug); cisplatin (Drug); carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Feasibility of Post-Surgery Chemotherapy |
38; 27; 18; 6; 1; 2 | — |
| SECONDARY Grade III/IV Adverse Events |
9; 6; 0; 3; 0; 3 | — |
| SECONDARY Overall Survival at 3 Years |
82.0; 83.2 | — |
| SECONDARY 3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years |
61.2; 67.3 | — |
| SECONDARY Overall Survival at 6 Years |
72.6; 83.2 | — |
Summary
This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC).
A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.
Eligibility Criteria
Inclusion Criteria
- Histologically proven non-small cell lung cancer stage Ib, IIa or IIb
- Must have complete tumor resection by pneumonectomy or lobectomy
- Must have been surgically proven to be N2 negative
Exclusion Criteria
- Serious concomitant systemic disorder
- Post-operative complications or other surgery related conditions
- A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago
Data sourced from ClinicalTrials.gov (NCT00269152). 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.