Clinical trial · Interventional
Nelfinavir, Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
A Phase I/II Trial of Protease Inhibitor, Nelfinavir, Given With Concurrent Thoracic Chemoradiotherapy in Patients With Locally-Advanced Non-Small Cell Lung Cancer
- 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)
RATIONALE: Nelfinavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Nelfinavir may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir together with radiation therapy, cisplatin, and etoposide may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir when given together with radiation therapy, cisplatin, and etoposide and to see how well they work in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| nelfinavir mesylate | Drug | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Nelfinavir
- interventionNames
- Drug: cisplatin
- Drug: etoposide
- Drug: nelfinavir mesylate
- Genetic: protein expression analysis
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Procedure: biopsy
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Dose-limiting Toxicity
- timeFrame
- 90 days
- description
- Any grade III or higher toxicity during chemoradiation, per CTCAE
- measure
- Maximum Tolerated Dose of Nelfinavir
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Locally advanced (stage III) disease * Unresectable disease * Candidate for concurrent definitive chemotherapy and thoracic radiotherapy, as determined by the treating physician * No malignant pleural effusion PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Bilirubin ≤ 1.5 mg/dL * AST or ALT ≤ 2 times upper limit of normal (ULN) * Creatinine ≤ 1.5 times ULN * FEV\_1 \> 600 cc * Not pregnant or nursing * Negative pregnancy test * No weight loss \> 10% within the past 6 months * No known HIV disease PRIOR CONCURRENT THERAPY: * No prior thoracic radiotherapy * No prior HIV protease inhibitors * More than 5 years since prior chemotherapy * At least 3 weeks since prior exploratory thoracotomy * No concurrent medications that would preclude nelfinavir administration, including any of the following: * Amiodarone * Quinidine * Rifampin * Dihydroergotamine * Ergonovine * Ergotamine * Methylergonovine * Hypericum perforatum (St. John's wort) * Lovastatin * Simvastatin * Pimozide * Midazolam * Triazolam
References
Publications (1)
- DERIVEDRengan R, Mick R, Pryma DA, Lin LL, Christodouleas J, Plastaras JP, Simone CB 2nd, Gupta AK, Evans TL, Stevenson JP, Langer CJ, Kucharczuk J, Friedberg J, Lam S, Patsch D, Hahn SM, Maity A. Clinical Outcomes of the HIV Protease Inhibitor Nelfinavir With Concurrent Chemoradiotherapy for Unresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer: A Phase 1/2 Trial. JAMA Oncol. 2019 Oct 1;5(10):1464-1472. doi: 10.1001/jamaoncol.2019.2095. PMID 31436839