Clinical trial · Interventional
Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients
NCT00350792CI-TRIAL-00004020completedPhase 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)
A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed + Carboplatin
- description
- Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
- interventionNames
- Drug: pemetrexed
- Drug: carboplatin
Primary outcomes (1)
- measure
- Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
- timeFrame
- baseline to measured objective tumor response (up to six 21-day cycles)
- description
- Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to radiotherapy treatment) or Stage IV * No previous chemotherapy for lung cancer * Men and women \> or = 70 years * At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In Solid Tumors \[RECIST\]criteria) * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 Exclusion Criteria: * Treatment within the last 30 days with a drug that has not received regulatory approval * Serious systemic disorders * Inability to discontinue administration of aspirin or anti-inflammatory non steroid * Concurrent administration of any other antitumor therapy * Brain metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.