Clinical trial · Interventional
Non-small Cell Lung Cancer Registry
A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis
- 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 trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. This trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage IV non-small cell lung cancer that cannot be treated by surgery.
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 |
|---|---|---|---|
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pleural Effusion, Malignant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
- measure
- Group 2: Observational
Secondary outcomes (6)
- measure
- Patients with an SRE will be evaluated for:
- measure
- Time from stage IIIB/IV NSCLC diagnosis to progression to bone
- measure
- Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
- measure
- The effect of serum NTX levels on the development of skeletal events (SREs), and
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than or equal to 18 years * Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma). * Unresectable Stage IIIB with pleural effusion or stage IV NSCLC * ECOG performance status of 0 or 1 Exclusion Criteria: * Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid) * Patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate) * Patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys * Known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate) * Abnormal renal function or creatinine clearance * Unstable brain metastasis * Women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding * Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol
References
Publications (0)
Data not yet available