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 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 20, 2024 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Massachusetts General Hospital
- Interventions being studied
- Drug: Afatinib; Radiation: Radiation; Drug: Cisplatin; Drug: Pemetrexed; Procedure: Surgery
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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)
- Pregnant or breastfeeding
- Prior EGFR TKI therapy
- Prior treatment with radiation to the thoracic region (including breast irradiation)
- Known pre-existing interstitial lung disease
- Significant or recent gastrointestinal disorders with diarrhea as a major symptom
- History or presence of relevant cardiovascular abnormalities
- Any other concomitant serious illness or organ system dysfunction
- Active hepatitis B, C or known HIV carrier
- Known or suspected active drug or alcohol use
- Known hypersensitivity to afatinib, cisplatin, or pemetrexed
- Concomitant treatment with strong inhibitor of P-gp
- History of an active malignancy within the last 3 years
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Massachusetts General HospitalBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 20, 2024. Always confirm current availability with the study team.