Phase 2
N=288
Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer
Non-small Cell Lung Cancer · Efficacy
Bottom Line
View on ClinicalTrials.gov: NCT01194453 ↗Enrolled (actual)
288
Serious AEs
3.5%
Results posted
Jun 2016
Primary outcome: Primary: Progression Free Survival (PFS) — 168; 140 day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin, dexamethasone,vitamin B12, folic acid (Drug); cisplatin, gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Yat-sen University
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
168; 140 | — |
| SECONDARY Response Rate |
24.41; 14.17 | — |
Summary
A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.
Eligibility Criteria
Inclusion Criteria
- Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV
- With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;
- with an Eastern CooperativeOncology Group performance status of 0 or 1,
- At least 18 years of age
- adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.
- Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment
- patients had fully recovered from its acute effects.
Exclusion Criteria
- peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1
- progressive brain metastases,
- uncontrolled third-space fluid retention before study entry.
- Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.
Data sourced from ClinicalTrials.gov (NCT01194453). 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.