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NCT01553942 · ClinicalTrials.gov registry record · Phase 2
Afatinib With CT and RT for EGFR-Mutant NSCLC
A Phase 2 study of Lung Cancer, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 2
- Study locations
NCT01553942: Active Phase 2 study of Lung Cancer, sponsored by Massachusetts General Hospital.
NCT01553942 is a Phase 2 study of Lung Cancer that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 19 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01553942, a Phase 2 study of Lung Cancer, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that study doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved the drug for the patients type of cancer or for any use outside of research studies. Chemotherapy and radiation is the standard treatment for the patients with stage III non-small cell lung cancer (NSCLC). For people with epidermal growth factor receptor (EGFR) mutations, adding a type of drug called a tyrosine kinase inhibitor (TKI) can help increase the response to treatment. Afatinib is a tyrosine kinase inhibitor. It has been studied in a previous research study in participants with more advanced NSCLC. Results from that study indicate it may be helpful in treating NSCLC with EGFR mutations. In this study, patients with stage III NSCLC and EGFR mutations will receive the standard treatment of radiation and chemotherapy. If possible, the patients tumor will be removed by surgery. Afatinib will be given before radiation and chemotherapy and after surgery. The aim of giving afatinib before radiation therapy is to try to shrink the tumor. This may make the radiation therapy more effective since radiation therapy tends to work better on smaller tumors. The goal of this study is to see if adding afatinib to standard treatment helps to improve the response to treatment.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed
- RADIATION Radiation
- PROCEDURE Surgery
- DRUG Afatinib
Study Locations (2)
Massachusetts
- Dana-Farber Cancer Institute - Boston
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-04 |
| Est. Completion | 2024-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01553942
The ClinicalTrials.gov registry entry for NCT01553942 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT01553942 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01553942 about?
NCT01553942 is a clinical study titled "Afatinib With CT and RT for EGFR-Mutant NSCLC". This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that study doctors are trying to find out more ...
What is the current status of trial NCT01553942?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2012-04. Estimated completion is 2024-12.
What conditions does trial NCT01553942 study?
This clinical trial studies the following conditions: Lung Cancer.
What interventions are being tested in trial NCT01553942?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG), Radiation (RADIATION), Surgery (PROCEDURE), Afatinib (DRUG).
Who is sponsoring clinical trial NCT01553942?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01553942 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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