EGF816 + Gefitinib for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug combination, EGF816 (an experimental treatment) and gefitinib, for EGFR mutation-positive non-small cell lung cancer. The researchers aim to determine if these drugs can effectively manage the cancer by targeting specific mutations in the cancer cells. Suitable participants have advanced non-small cell lung cancer with an EGFR mutation and have not undergone extensive prior treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take medications that strongly affect CYP3A4, an enzyme that processes many drugs. It's best to discuss your current medications with the trial team to ensure there are no interactions.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that gefitinib is commonly used to treat lung cancer and is generally well-tolerated by patients. Studies have found that it helps people with non-small cell lung cancer live longer and manage their symptoms better. With over ten years of data, gefitinib is considered safe for long-term use, and many patients do not experience severe side effects.
EGF816 has not been as extensively studied, but like gefitinib, it targets specific cancer mutations. This trial is in Phase 2, indicating that earlier studies found it safe enough for further testing. However, there is less information about its long-term effects compared to gefitinib.
When used together, EGF816 and gefitinib aim to treat lung cancer more effectively. While some information exists on each drug separately, the safety of using them together is still under investigation. Participants in this trial help researchers learn how well these drugs work together and assess their safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining EGF816 with Gefitinib for lung cancer because this duo targets cancer cells in a unique way. Gefitinib is already known for blocking signals that help cancer cells grow, but EGF816 takes it a step further by specifically inhibiting a mutated form of the EGFR protein found in many lung cancers. This combination could potentially tackle cancer more effectively by addressing both the growth signals and the mutation directly, offering hope for improved outcomes compared to existing treatments like EGFR inhibitors alone.
What evidence suggests that this trial's treatments could be effective for EGFR mutation-positive lung cancer?
Research has shown that gefitinib effectively treats non-small-cell lung cancer, particularly in patients with specific EGFR gene changes. It helps patients live longer without their cancer worsening and is generally well-tolerated, allowing patients to feel better while taking it. Although less information exists about EGF816, this trial uses it with gefitinib because both target EGFR gene changes common in some lung cancers. This trial tests the combination to determine if it can be more effective by attacking the cancer in different ways.45678
Who Is on the Research Team?
Zofia Piotrowska, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults with advanced non-small cell lung cancer that has specific EGFR mutations and no prior extensive treatment. They must have good organ function, agree to use effective contraception, and not be pregnant or breastfeeding. Prior chemotherapy is limited to one line in the metastatic setting.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive EGF816 and gefitinib orally once daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EGF816
- Gefitinib
Trial Overview
The study tests a combination of two drugs, EGF816 and Gefitinib, as potential treatments for lung cancer with certain genetic changes (EGFR mutation-positive). It aims to see how well these drugs work together in patients who haven't tried similar therapies before.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
* All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania
Citations
gefitinib in special non-small-cell lung cancer patient ...
Gefitinib ('Iressa', ZD1839) 250 mg day−1 is well tolerated and has proven antitumour and symptom improvement activity in patients with previously treated NSCLC ...
Gefitinib or Chemotherapy for Non–Small-Cell Lung ...
First-line gefitinib for patients with advanced non–small-cell lung cancer who were selected on the basis of EGFR mutations improved progression-free survival.
Comparison of gefitinib plus chemotherapy versus ...
This meta-analysis shows that gefitinib plus chemotherapy showed significantly better efficacy in improving objective response rate, disease control rate, ...
Final Overall Survival Results from a Phase III ...
The objective of this report is to provide a mature analysis of overall survival (OS) for Iressa in NSCLC for maintenance study in intention to treat (ITT) ...
a new therapy for advanced non-small-cell lung cancer
Overall, the 250 mg/day dose was better tolerated than 500 mg/day and this, combined with similar results for efficacy endpoints with the two doses, makes 250 ...
A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant ...
Both EGF816 and gefitinib are inhibitors which target a specific mutation in cancer and may stop tumors growing and multiplying. Official Title. A Phase 2 Study ...
Gefitinib in Non Small Cell Lung Cancer - PMC
The results of these trials have demonstrated the efficacy of gefitinib that can be now considered as the standard first-line treatment of patients with ...
Long-term safety and survival with gefitinib in select ...
This is the first report of long-term (>10 years) safety, tolerability, and survival data on patients with non-small cell lung cancer (NSCLC) who received ...
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