NCT01553942Active, not recruitingPhase 2
Afatinib With CT and RT for EGFR-Mutant NSCLC
Afatinib Sequenced With Concurrent Chemotherapy and Radiation in EGFR-Mutant Non-Small Cell Lung Tumors: The ASCENT Trial
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 5 Mar 2012
- Start date
- Apr 2012
- Primary completion date
- Dec 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Lung cancer
- NCT number
- NCT01553942
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 19
- From Apr 2012 to the primary completion date, Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with radiation to the thoracic region (including breast irradiation)
- Any other concomitant serious illness or organ system dysfunction
- Known or suspected active drug or alcohol use
- Concomitant treatment with strong inhibitor of P-gp
Other illness
- Known pre-existing interstitial lung disease
- Significant or recent gastrointestinal disorders with diarrhea as a major symptom
- Active hepatitis B, C or known HIV carrier
- Known hypersensitivity to afatinib, cisplatin, or pemetrexed
- History of an active malignancy within the last 3 years
Lab values
- Prior EGFR TKI therapy
Other
- Pregnant or breastfeeding
- History or presence of relevant cardiovascular abnormalities
Who the study is looking for
- Histologically confirmed stage IIIA NSCLC
- Measurable disease
- Have lung cancer harboring an EGFR mutation
- Must be evaluated by a medical oncologist, radiation oncologist and thoracic surgeon within 4 weeks of enrollment into study to document that they are a candidate for chemoradiation and for consideration of surgical resection (not required to be a surgical candidate)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.