Clinical trial · Interventional
Safety of Everolimus and Pemetrexed in Lung Cancer Patients
A Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy
NCT00434174CI-TRIAL-00049032completedPhase 1ClinicalTrials.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)
This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with 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 |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- everolimus + Pemetrexed - daily
- description
- Daily treatment
- interventionNames
- Drug: Everolimus
- Drug: Pemetrexed
- type
- EXPERIMENTAL
- label
- everolimus + Pemetrexed - weekly
- description
- Weekly treatment
- interventionNames
- Drug: Everolimus
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Lung cancer * Only one prior regimen of chemotherapy for the treatment of non small cell lung cancer * Adequate bone marrow function * Adequate liver function * Adequate renal function * Negative serum pregnancy test Exclusion criteria: * History of another primary malignancy in the last 5 years * Having recently received an investigational drug * Having recently received major surgery of wide field radiotherapy * Chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators * Severe or uncontrolled medical conditions Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.