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Protein Kinase Inhibitor
Targeted Therapy for Lung Cancer
Phase 2
Waitlist Available
Led By Arun Rajan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years
Patients with histologically confirmed advanced Non-Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), and thymic malignancies for whom surgical resection or multimodality therapy with curative intent is not feasible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing 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.
Who is the study for?
Adults over 18 with advanced lung or thymus cancer not curable by surgery/radiation can join. They must be able to undergo a biopsy, have previous tissue for analysis, or prior successful gene profiling. Excluded are those who could have curative therapy, can't swallow tablets, had recent major treatment/surgery, have symptomatic brain metastases, are pregnant/breastfeeding, or have uncontrolled illnesses.Check my eligibility
What is being tested?
The trial tests targeted drugs based on genetic abnormalities in tumors: Erlotinib for EGFR mutations; AZD6244 for KRAS/BRAF/HRAS/NRAF mutations; MK-2206 for PIK3CA/AKT/PTEN mutations; Sunitinib for KIT/PDGFRA mutations; Lapatinib for ERBB2 mutation/amplification. Treatment continues unless disease progresses or side effects become intolerable.See study design
What are the potential side effects?
Potential side effects include skin reactions (rashes), diarrhea and liver issues from Erlotinib; fatigue and vision changes from AZD6244; rash and high blood sugar from MK-2206; hypertension and fatigue from Sunitinib; and diarrhea and skin rashes from Lapatinib. Individual responses may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have advanced lung or thymic cancer and cannot be treated with surgery or combined treatments aimed at a cure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Evaluable Participants With a Response Based on Molecular Profile Directed Treatments in Non-Small Cell Lung Cancer, (NSCLC), Small Cell Lung Cancer (SCLC), and Thymic Malignancies
Percentage of Enrolled Participants Testing Positive for Genomic Abnormality
Percentage of Evaluable Participants Overall Response Rate (ORR) Based on the Drug Selected for Their Particular Profile
Secondary outcome measures
Frequency of Epidermal Growth Factor Receptor (EGFR) Germline Mutations in Families With High Susceptibility to Lung Cancer
Other outcome measures
Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: F/ Not Otherwise Specified (NOS)Experimental Treatment1 Intervention
Participants who do not meet the eligibility criteria for enrollment
Group II: B/ AZD6244Active Control2 Interventions
AZD6244 Hydrogen Sulfate 75 mg by mouth (PO) every (Q) 12 Hours
Group III: D/ LapatinibActive Control2 Interventions
Lapatinib 1500 mg by mouth (PO) every day (QD)
Group IV: A/ ErlotinibActive Control2 Interventions
Arm A - Erlotinib 150 mg by mouth (PO) every morning (QAM)
Group V: E/SunitinibActive Control2 Interventions
Sunitinib 50 mg by mouth (PO) on days 1-28
Group VI: C/ MK-2206Active Control2 Interventions
MK-2206 200 mg by mouth (PO) every (Q) Week
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,506 Total Patients Enrolled
Arun Rajan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
15 Previous Clinical Trials
3,089 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor can potentially be cured, as assessed by my doctor.I have brain metastases that are causing symptoms.I have Stage III lung cancer and have received or am eligible for definitive radiation therapy.I am 18 years old or older.I haven't had major surgery, chemotherapy, or radiotherapy in the last 2 weeks.I have advanced lung or thymic cancer and cannot be treated with surgery or combined treatments aimed at a cure.My advanced cancer can be or has been tested for specific genetic changes.I do not have any uncontrolled illnesses that would prevent me from undergoing a biopsy or receiving experimental treatment.I am eligible for EGFR mutation testing but my cancer is not advanced.I am not on any experimental drugs or other cancer treatments.You have a condition that makes it hard for you to swallow or keep down pills.
Research Study Groups:
This trial has the following groups:- Group 1: B/ AZD6244
- Group 2: D/ Lapatinib
- Group 3: A/ Erlotinib
- Group 4: E/Sunitinib
- Group 5: F/ Not Otherwise Specified (NOS)
- Group 6: C/ MK-2206
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are eligible to participate in this research?
"This study has ceased accepting participants, as the most recent update was posted on October 20th 2022. However, there are 3,894 studies currently recruiting for thymic carcinoma and 131 trials actively seeking patients looking to participate in A/ Erlotinib research."
Answered by AI
In what medical situations does A/ Erlotinib have the most therapeutic efficacy?
"Erlotinib is normally used to treat cancerous growths, and can additionally be employed to combat pancreatic carcinoma, chemotherapy-induced disease progression, and gastrointestinal stromal tumors."
Answered by AI
Are there still opportunities to take part in this research?
"Currently, this trial is not admitting any more participants. The listing was first published on February 8th 2011 and last updated October 20th 2022. Nonetheless, if you are seeking other medical studies for thymic carcinoma there are currently 3893 active clinical trials or 131 accepting patients to take part in A/ Erlotinib testing."
Answered by AI
Has A/ Erlotinib been given the greenlight by the FDA?
"According to our assessment, A/ Erlotinib's safety is rated as a 2 on the scale of 1-3. This suggests that while there is some data confirming its security profile, no clinical evidence exists regarding its efficacy yet."
Answered by AI
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