A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- The Feasibility of Post-Surgery Chemotherapy
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A: Pemetrexed + Cisplatin
Intervention: pemetrexed (Drug)
A: Pemetrexed + Cisplatin
Intervention: cisplatin (Drug)
B: Pemetrexed + Carboplatin
Intervention: pemetrexed (Drug)
B: Pemetrexed + Carboplatin
Intervention: carboplatin (Drug)
Outcomes
Primary Outcomes
The Feasibility of Post-Surgery Chemotherapy
Time Frame: every 21-day cycle for 4 cycles up to 30 days after last infusion
Feasibility was measured by completion of 4 treatment cycles without remaining toxicities \>=Grade 3 at 30 days after last infusion.
Secondary Outcomes
- Grade III/IV Adverse Events(every 21-day cycle for 4 cycles)
- Overall Survival at 3 Years(baseline to date of death from any cause, assessed at 3 years)
- 3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years(length of time disease free, assessed at 3 years)
- Overall Survival at 6 Years(Baseline to date of death from any cause assessed at 6 years)