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NCT01306045 · ClinicalTrials.gov registry record · Phase 2
Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 647
- Enrollment target
NCT01306045: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01306045 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 647 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (386% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01306045, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 647 participants
- Enrollment target
Study Summary
Background: \- The current standard of care for advanced lung cancer and cancers of the thymus consists primarily of chemotherapy treatment. The drugs used for chemotherapy depend on the classification of the cancer in different categories that are based on the appearance of the cancer in the microscope. Though this approach has been proved to be useful in some ways, the survival rates of individuals with lung cancer and cancers of the thymus are still very poor. Recent research has shown that several genetic abnormalities play an important role in the development and growth of lung cancer and cancers of the thymus, and that it is possible to improve treatment success rates with drugs that specifically target some of the abnormal genes. Researchers are interested in determining whether it is possible to analyze the genes of patients with lung cancer and cancers of the thymus in order to provide personalized treatment with drugs that target the specific gene abnormalities. Objectives: \- To evaluate the effectiveness of genetic analysis in determining targeted therapy for individuals with advanced non-small cell lung cancer, small cell lung cancer, and thymic cancer. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with either lung cancer or a cancer of the thymus that is not considered to be curable with the use of surgery or radiation therapy. Design: * Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies. Participants will have a tumor biopsy or provide previously collected tumor tissue for study. * Based on the results of the tumor biopsy study, participants will be separated into different treatment groups: * Participants with epidermal growth factor receptor (EGFR) gene mutation will receive a drug called erlotinib, which inhibits a protein called EGFR that is thought to be a key factor in the development and progression of some cancers. * Particip
Primary Outcome
To determine the feasibility of the use of tumor molecular profiling and targeted therapies in the treatment of Non-Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), and Thymic Malignancies, the trial will be evaluated by determining the percentage of enrolled participants with a genomic abnormality. Identifying molecular profiles may help identify new targeted treatments for cancer.
Interventions
- DRUG Sunitinib
- DRUG Erlotinib
- DRUG Lapatinib
- DRUG AZD6244
- DRUG MK-2206
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 647 participants |
| Start Date | 2011-02-08 |
| Est. Completion | 2024-07-17 |
| Phase | Phase 2 |
What the finished NCT01306045 record still lists
NCT01306045 is an interventional study that assigns participants to a tested intervention. The registered 647 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (386% higher).
The record links to 0 conditions, and to 5 interventions - of which Sunitinib is the first listed.
NCT01306045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01306045 about?
NCT01306045 is a clinical study titled "Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies". Background: \- The current standard of care for advanced lung cancer and cancers of the thymus consists primarily of chemotherapy treatment. The drugs used for chemotherapy depend on the classification of the cancer in different categories that are based on the appearance of the cancer in the micro...
What is the current status of trial NCT01306045?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 647 participants. The study started on 2011-02-08. Estimated completion is 2024-07-17.
What interventions are being tested in trial NCT01306045?
The interventions under investigation include: Sunitinib (DRUG), Erlotinib (DRUG), Lapatinib (DRUG), AZD6244 (DRUG), MK-2206 (DRUG).
Who is sponsoring clinical trial NCT01306045?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01306045's enrollment target sits among peer trials
647 50th of 2000 higher than 1,951 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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