Clinical trial · Interventional
A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer
An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer
NCT01165021CI-TRIAL-00040841completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Folic Acid | Drug | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Vitamin B12 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed + Cisplatin
- interventionNames
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Folic Acid
- Drug: Vitamin B12
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
- timeFrame
- From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy
- description
- Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size \[\<10 millimeter (mm) short axis\]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.