Clinical trial · Interventional
Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases
NCT01578668CI-TRIAL-00016696completedPhase 2ClinicalTrials.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 study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| erlotinib | Drug | Erlotinib | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib, pemetrexed, cisplatin
- interventionNames
- Drug: erlotinib
- Drug: pemetrexed
- Drug: cisplatin
- type
- EXPERIMENTAL
- label
- erlotinib
- interventionNames
- Drug: erlotinib
Primary outcomes (1)
- measure
- The objective response rate of brain metastases
- timeFrame
- Patients will be followed for an expected average of 6 weeks
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases 2. 18 years or older 3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom) 4. Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter \> 5 mm by brain MRI 5. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L 6. Total bilirubin 1.5 x upper limit of normal (ULN) 7. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases 8. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula) 9. If received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy. Exclusion Criteria: 1. Mixed non-adenocarcinoma cell lung cancer histology 2. Previous treatment with pemetrexed or tarceva 3. Be allergic to pemetrexed or tarceva
References
Publications (0)
Data not yet available
No reference posted for this study.