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NCT01281124
Azacitidine in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
Phase 2 trial testing Azacitidine in Recurrent Lung Non-Small Cell Carcinoma in 1 participant. Completed in 12 September 2012.
15 April 2011
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 12 January 2011 |
| Primary completion | 15 April 2011 |
| Estimated completion | 12 September 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Azacitidine (azacitidine) — full drug profile →
- Diagnostic Laboratory Biomarker Analysis
- Pharmacological Study — full drug profile →
Conditions studied
- Recurrent Lung Non-Small Cell Carcinoma — all drugs for Recurrent Lung Non-Small Cell Carcinoma →
- Stage IV Lung Non-Small Cell Cancer AJCC v7 — all drugs for Stage IV Lung Non-Small Cell Cancer AJCC v7 →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, any sex, with Recurrent Lung Non-Small Cell Carcinoma or Stage IV Lung Non-Small Cell Cancer AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (12 terms)
| Reaction | System | Treatment (Azacitidine) |
|---|---|---|
| Cardiac Arrest | Cardiac disorders | — |
| Pericardial effusion | Cardiac disorders | — |
| Pericardial tamponade | Cardiac disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Insomnia | Psychiatric disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
Other adverse events (8 terms — click to expand)
| Reaction | System | Treatment (Azacitidine) |
|---|---|---|
| Urticaria (Welts) | Skin and subcutaneous tissue disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Pneumonia-Viral | Infections and infestations | — |
| Lymphopenia | Investigations | — |
| Depression | Psychiatric disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Fatigue | General disorders | — |
Most-reported serious reactions: Cardiac Arrest, Pericardial effusion, Pericardial tamponade, Lymphocyte count decreased, Anorexia, Hypoalbuminemia, Hypocalcemia, Hyponatremia.
Data from ClinicalTrials.gov NCT01281124 adverse events section.
Sponsor's own description
This phase II clinical trial is studying how well azacitidine works in treating patients with previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Use of DNA methylation patterns for early detection and management of lung cancer: Are we there yet?
Kontic M, Markovic F. · · 2025 · cited 4× · PMID 40191732 · DOI 10.32604/or.2024.057231
Verify or expand the search:
- PubMed search for NCT01281124
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Recurrent Lung Non-Small Cell Carcinoma
Currently open trials in the same condition.
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- NCT06616623 — Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer · Phase 1 · recruiting
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- NCT05642572 — Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A L · Phase 2 · recruiting
- NCT05570825 — SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer · Phase 2 · recruiting
Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
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- NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01281124 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 24 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01281124.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing