Clinical trial · Interventional
A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer
A Randomized Study of the Safety and Efficacy of BIO-11006 in Treatment of Advanced Non-Small Cell Lung Cancer in Patients Who Are Not Candidates for Curative Surgery and/or Radiation and Who Are Receiving Pemetrexed and Carboplatin
NCT03472053CI-TRIAL-00045161completedPhase 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)
This Phase 2 is a randomized study in advanced Non-Small Cell lung cancer patients to evaluate safety and efficacy of aerosolized BIO-11006 in conjunction with chemotherapy.
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 Stage IIIB | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIO-11006 plus standard of care | Drug | — | UNRESOLVED |
| Standard of Care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BIO-11006 plus standard of care
- description
- Aerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months.
- interventionNames
- Drug: BIO-11006 plus standard of care
- type
- EXPERIMENTAL
- label
- Standard of Care
- description
- Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's Formula) is administered every three weeks for three months.
- interventionNames
- Drug: Standard of Care
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who are physically able to self administer drug by nebulizer; 2. Measurable disease per RECIST Version 1.1; 3. Female patients of child bearing age must have a negative pregnancy test; 4. ECOG 0-2; 5. Written informed consent; Exclusion Criteria: 1. Candidates for curative surgery and/or radiation therapy; 2. Baseline ANC\<2000 cells/mm cube; platelet count \<100,000 cells/mm cube 3. Creatinine clearance \<45 mL/min; 4. Billirubin \>2 x the upper limit of normal 5. Known history of HIV, hepatitis B, hepatitis C or tuberculosis; 6. Current pneumonia or idiopathic pulmonary fibrosis; 7. Hypersensitivity to test drug, pemetrexed, or carboplatin.
References
Publications (0)
Data not yet available
No reference posted for this study.