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Osimertinib Rechallenge for Lung Cancer (OCELOT Trial)
Phase 2
Recruiting
Led By Mark Vincent, MD
Research Sponsored by Mark Vincent
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Additional Criteria for patients enrolling at the time of third-line osimertinib rechallenge: Subjects must have complete baseline demographic data available (age at diagnosis of metastatic non-small cell lung cancer (NSCLC), ethnicity, smoking status, sex, history of brain metastasis) and the following must be available (if applicable): Date of first dose of osimertinib, date that first-line osimertinib was permanently discontinued, date of first-line progression, date second-line chemotherapy was started, which platinum chemotherapy was given, if pemetrexed maintenance was given, date that second-line chemotherapy was permanently stopped, and date of progression on second-line treatment. Patients must have received platinum/ pemetrexed chemotherapy in the second-line chemotherapy Subjects must have measurable disease defined as at least one measurable lesion that can be accurately assessed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) at baseline and follow up visits.Subjects must have measurable disease defined as at least one measurable lesion that can be accurately assessed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) at baseline and follow up visits.
Pathologically proven advanced non-small cell lung cancer (i.e. stage M1 (metastasis), or earlier stages if unfit or unsuitable for radical treatment). Patients must have a tissue diagnosis of lung cancer, either by histology or cytology, however, in the event that there is insufficient tissue for molecular analysis, mutations identified in circulating tumor deoxyribonucleic acid (ctDNA) analysis will be permitted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study (approximately 4 years)
Awards & highlights
OCELOT Trial Summary
This trial is for patients with lung cancer who have already tried two different treatments, one of which was osimertinib. They will receive osimertinib again to see if it is a safe and effective third-line option.
Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) and specific EGFR mutations can join this trial. They must have had osimertinib as a first treatment, platinum plus pemetrexed chemotherapy second, and be fit for third-line therapy. Key requirements include measurable disease by CT/MRI, life expectancy over 12 weeks, ECOG/WHO-PS of 0-3, and use of effective contraception if applicable.Check my eligibility
What is being tested?
The study tests the effectiveness of reusing osimertinib in third-line treatment after it was used first-line followed by platinum-pemetrexed chemo. It's a phase II trial to see if retreating with osimertinib is safe and works well for patients whose cancer has progressed despite previous treatments.See study design
What are the potential side effects?
Osimertinib may cause side effects like diarrhea, rash, dry skin, nail changes or mouth sores. More serious risks include lung problems (like trouble breathing), heart issues (like abnormal heartbeat), eye problems or allergic reactions.
OCELOT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Patients enrolling for the third-line osimertinib rechallenge need to have specific information about their medical history and previous treatments available. They must have received a certain type of chemotherapy in the second-line treatment, and have measurable disease that can be accurately assessed by CT or MRI scans at baseline and follow-up visits.
Select...
My lung cancer is advanced, and I have a confirmed diagnosis.
Select...
I can perform daily activities and might be eligible for more treatment.
OCELOT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study (approximately 4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study (approximately 4 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors version 1.1
Secondary outcome measures
Disease Control Rate according to Response Evaluation Criteria in Solid Tumors version 1.1
Disease Control Rate according to Response Evaluation Criteria in Solid Tumors version 1.1 in the Atypical Epidermal Growth Factor Receptor Mutation Population
Duration of Response according to Response Evaluation Criteria in Solid Tumors version 1.1
+14 moreOther outcome measures
Analysis of Genetic Markers in Blood Samples
Analysis of Genetic Markers in Tissue
Analysis of Mutations in Circulating Tumor Deoxyribonucleic Acid Blood Samples
+8 moreOCELOT Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment3 Interventions
First-line treatment = osimertinib, 80 mg, oral, daily; Second-line treatment = platinum (carboplatin or cisplatin) + pemetrexed chemotherapy, prescribed as per institutional standards; Third-line treatment = osimertinib rechallenge, 80 mg, oral, daily.
Patients may enter the study at first-line treatment, second-line treatment, or third-line treatment. This is dependent on meeting the eligibility criteria.
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Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,659 Total Patients Enrolled
Mark VincentLead Sponsor
Mark Vincent, MDPrincipal InvestigatorLawson Health Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Patients enrolling for the third-line osimertinib rechallenge need to have specific information about their medical history and previous treatments available. They must have received a certain type of chemotherapy in the second-line treatment, and have measurable disease that can be accurately assessed by CT or MRI scans at baseline and follow-up visits.If you have not started treatment with osimertinib yet, you should not have had any previous systemic therapy for EGFR+ advanced Non-Small Cell Lung Cancer. Additionally, your heart should not have certain abnormalities, and you should not have any factors that increase the risk of heart rhythm abnormalities.I don't have severe side effects from past treatments, except for hair loss or mild nerve pain from platinum-based therapy.I haven't had another cancer, besides non-melanoma skin cancer, in the last 3 years.I have had chemotherapy to prevent cancer return within the last 6 months.I've only had osimertinib for my EGFR+ aNSCLC, then platinum with pemetrexed, and it's been 90 days since my last osimertinib dose.I have all my basic health information and specific dates related to my lung cancer treatment ready.I am not taking any strong CYP3A4 inducers, or can stop them before starting the study treatment.My blood tests show my organ function is not within the required range.I am not pregnant, not breastfeeding, and using effective birth control or am not able to have children.I am 18 years old or older.You have had a bad reaction to osimertinib or similar drugs in the past.It refers to specific requirements for patients who are enrolling for the third round of treatment with osimertinib.I have stable brain metastases or spinal cord issues but am stable after treatment.I do not have severe illnesses or infections that could affect my trial participation.I have not had anti-PD-1 or anti-PD-L1 therapy in the last 90 days.I cannot take osimertinib due to severe nausea, vomiting, gut diseases, swallowing issues, or major bowel surgery.My lung cancer is advanced, and I have a confirmed diagnosis.I haven't taken any experimental drugs recently.I can perform daily activities and might be eligible for more treatment.I have a history of lung conditions that needed steroid treatment.My cancer has a specific EGFR mutation, but not the Exon 20 type.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
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.
Osimertinib Third-Line is typically used to treat what stage of cancer?
"Osimertinib Third-Line is most commonly used to manage ovarian cancer, however it can also be helpful for patients with mesotheliomas, locally advanced nonsquamous non-small cell lung cancer, and unresectable thymoma."
Answered by AI
In how many different locations is this trial taking place?
"This trial has 10 open sites, which are located at the Princess Margaret Hospital in Toronto, Hamilton Health Sciences Centre, Juravinski Cancer Centre in Hamilton, London Regional Cancer Program of the Lawson Health Research Institute in London. The other 6 locations are ____."
Answered by AI
How many people are participating in this test?
"Yes, as of today, this clinical trial is still recruiting patients. The 10 sites enrolling participants were first announced on 1/6/2021, with the most recent update appearing on 6/21/2022. In total, 200 individuals are needed for the study."
Answered by AI
Are there any other case studies that compare Osimertinib to other drugs?
"Osimertinib Third-Line was first researched in 2002 at Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital. As of now, 401 clinical trials have been completed with 460 more active studies. Many of these ongoing investigations are based in Toronto, Ontario."
Answered by AI
Are we still able to enroll people in this research project?
"Yes. The clinical trial is currently recruiting patients, as per the information available on clinicaltrials.gov. This particular study was originally posted on 1/6/2021 and was most recently edited on 6/21/2022; it is looking for 200 participants in total, to be recruited from 10 different sites."
Answered by AI
Does the FDA condone Osimertinib as a last resort treatment?
"Osimertinib Third-Line, which is currently in Phase 2 clinical trials, has some data supporting its safety but none yet regarding efficacy."
Answered by AI
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