Phase 2
Completed N=19
A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01165021 ↗Enrolled (actual)
19
Serious AEs
10.5%
Results posted
May 2014
Primary outcomePrimary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] — 41.2 percentage of participants
Summary
The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] |
41.2 | — |
| SECONDARY Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)] |
93.3 | — |
| SECONDARY Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0 |
29.4; 29.4; 11.8; 17.6; 11.8 | — |
| SECONDARY Overall Survival (OS) |
34.6 | — |
| SECONDARY Progression-Free Survival (PFS) |
12.4 | — |
Eligibility Criteria
Inclusion Criteria
- Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy
- Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
- Tumor considered potentially resectable
- Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG)
- No prior therapy for lung cancer
- Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
- Life expectancy of at least 6 months
- Organs are functioning well (bone marrow reserve, liver, kidney, lung)
- Signed Informed Consent
- Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.
- Men must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug.
- Be fit for surgery at the time of enrollment
Exclusion Criteria
- Receiving or have received an investigational drug or device within the last 30 days
- Have previously completed or withdrawn from this study or any other study investigating pemetrexed
- Serious concomitant systemic disorder
- Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
- Receiving concurrent administration of any other anticancer therapy
- Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
- Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids)
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day
Data sourced from ClinicalTrials.gov (NCT01165021). 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. Informational only — not medical advice.