Clinical trial · Interventional
Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer
A Phase II Trial of the HIV Protease Inhibitor Nelfinavir and Concurrent Radiation and Chemotherapy in Patients With Stage III Non Small Cell Lung Cancer
NCT00791336CI-TRIAL-00028819terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor enrollment.
Summary
Brief summary (as posted)
This study combines nelfinavir (NFV) with radiation therapy and chemotherapy as a treatment for non-small cell lung cancer (NSCLC) who are considered candidates for pre-operative treatment.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nelfinavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nelfinavir
- interventionNames
- Drug: Nelfinavir
Primary outcomes (1)
- measure
- Pathologic Complete Response
- timeFrame
- 30 days
Secondary outcomes (2)
- measure
- Characterization of Overall and Disease-free Survival
- timeFrame
- long-term
- measure
- Safety and Tolerability of the Combined Treatment Regimen
- timeFrame
- 7 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of non-small cell lung cancer that is Stage III (T1-3, pN2, M0) NSCLC in whom neoadjuvant therapy is recommended. * Must have had a mediastinoscopy to determine nodal status and potential resectability * Must have enough tissue from the biopsy for tissue marker determination for correlative studies * Negative metastatic work up (FDG PET/CT, brain CT or MRI) * No prior thoracic radiotherapy will be permitted * Age 18 years or greater * ECOG performance status 0-1 (Karnofsky at least 70%) * Normal organ and marrow function * No known HIV infection * Not pregnant * Ability to understand and the willingness to sign an informed consent document Exclusion Criteria: * Patients requiring a pneumonectomy * Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study, or who have not recovered from adverse events due to agents administered earlier. * Prior thoracic radiation * Treatment with any other investigational agents. * Known metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to NFV * Patients receiving drugs contraindicated with NFV will be excluded. * Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study compliance. * Pregnant or lactating women * HIV-positive patients on combination antiretroviral therapy
References
Publications (0)
Data not yet available
No reference posted for this study.