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Kinase Inhibitor
Savolitinib + Osimertinib for Lung Cancer (CoC Trial)
Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have received at least one but no more than 3 prior lines of therapy (including investigational therapy) in the locally advanced/metastatic setting
Eastern Cooperative Oncology Group/WHO performance status of 0 or 1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the primary analysis will occur 6 months after the last patient is randomised.
Awards & highlights
CoC Trial Summary
This trial will compare the effectiveness of savolitinib with osimertinib or a placebo in treating patients with lung cancer that has spread and who have already been treated with osimertinib.
Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) that has specific mutations (EGFRm+) and MET amplification, who have seen their disease progress after osimertinib treatment. They should have tried no more than three prior therapies, be in relatively good health with a life expectancy of at least 12 weeks, and agree to use contraception. Those with certain heart conditions, active infections like hepatitis or HIV, other cancers within the last five years, or severe illnesses are excluded.Check my eligibility
What is being tested?
The trial is testing if adding Savolitinib to Osimertinib is better than adding a placebo for patients whose NSCLC has worsened despite previous Osimertinib therapy. Participants will receive either both drugs or one drug plus a placebo to see which combination is more effective in controlling cancer growth.See study design
What are the potential side effects?
Possible side effects include typical reactions from targeted cancer therapies such as diarrhea, rash, dry skin; liver enzyme changes; fatigue; decreased appetite; cough; nausea; and potential heart issues like abnormal ECG readings. The severity can vary among individuals.
CoC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had 1 to 3 treatments for my advanced cancer.
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I can care for myself and have not gotten worse in the past 2 weeks. Doctors expect me to live at least 12 more weeks.
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My cancer progressed after treatment with osimertinib.
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My advanced lung cancer has a specific EGFR mutation sensitive to certain treatments.
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My cancer has MET amplification after treatment with osimertinib.
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I am at least 18 years old (20 if in Japan) and can consent to participate.
CoC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the primary analysis will occur 6 months after the last patient is randomised. the final analysis will occur at the earlier of 18 months after the last patient is randomised or when 70% of patients have progressed or died.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the primary analysis will occur 6 months after the last patient is randomised. the final analysis will occur at the earlier of 18 months after the last patient is randomised or when 70% of patients have progressed or died.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Brain Diseases, Metabolic
CLss/F of savolitinib, osimertinib and their metabolites, (M2 and M3 for savolitinib; AZ5104 for osimertinib)
Cssmax of savolitinib, osimertinib and their metabolites, (M2 and M3 for savolitinib; AZ5104 for osimertinib)
+41 moreOther outcome measures
HLA alleles associated with susceptibility to drug related AEs (such as but not limited to hypersensitivity).
Overall survival, in patients who cross over after progression on savolitinib plus placebo
CoC Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
Group II: Arm AExperimental Treatment1 Intervention
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,251 Previous Clinical Trials
288,537,271 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a visible and measurable area of the disease that can be monitored during the trial.You currently have active hepatitis B or C.I can care for myself and have not gotten worse in the past 2 weeks. Doctors expect me to live at least 12 more weeks.I haven't taken any cancer drugs for my advanced lung cancer in the last 14 days, except for osimertinib.I am allergic to osimertinib, savolitinib, or similar drugs.My cancer progressed after treatment with osimertinib.I have undergone 4 or more treatments for non-small cell lung cancer.I have had lung inflammation or damage that needed steroids.I do not have stomach or bowel issues affecting medication absorption.I am not pregnant, not breastfeeding, and willing to use birth control.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days, except for port-a-cath placement.I have been treated with a MET inhibitor like savolitinib.I am not taking strong medication or herbal supplements that affect enzyme levels.My advanced lung cancer has a specific EGFR mutation sensitive to certain treatments.My brain or spinal tumors are stable, cause no symptoms, and I haven't needed steroids for 2 weeks.I haven't had extensive radiotherapy in the last 28 days or small area radiotherapy in the last 7 days.I have not taken part in another cancer drug study within the last 14 days.I have had 1 to 3 treatments for my advanced cancer.I have not had serious heart issues or uncontrolled high blood pressure in the last 6 months.My cancer has MET amplification after treatment with osimertinib.I am at least 18 years old (20 if in Japan) and can consent to participate.I agree to use barrier contraception and not donate sperm for 6 months after the study ends.I have been treated with a specific lung cancer medication other than osimertinib.I don't have severe side effects from past treatments, except for possible hair loss, mild neuropathy, or if my hemoglobin is above 9.I do not have any serious active infections like tuberculosis or HIV.My blood, liver, and kidney functions are all within normal ranges.I haven't had treatment for invasive cancer in the last 5 years, except for early-stage or non-invasive cancers.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Awards:
This trial has 0 awards, including: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.
Has the FDA acknowledged Osimertinib + Savolitinib as a viable treatment?
"Osimertinib + Savolitinib received a safety score of 2. This is due to the fact that while there is some data indicating that it is safe, there is no evidence yet demonstrating its efficacy in Phase 2 trials."
Answered by AI
Does this scientific research break new ground?
"Osimertinib + Savolitinib has been researched since 2013. The initial trial was conducted in 2013 and was sponsored by AstraZeneca. Following the first trial in 2013, which involved 603 patients, Osimertinib + Savolitinib received its Phase 1 & 2 drug approval. Today there are 116 active trials for Osimertinib + Savolitinib across 1082 cities and 51 countries."
Answered by AI
Would you please summarize the prior research on Osimertinib + Savolitinib?
"Osimertinib + Savolitinib was first trialled in 2013 and, as of now, there have been 45 completed studies. Out of the 116 active trials, many are conducted in Brooklyn, New york."
Answered by AI
What is the largest amount of people that can join this trial?
"Unfortunately, this trial is no longer looking for participants. It was active between September 28th 2020 and September 7th 2022. For patients interested in other studies, 2098 trials are currently recruiting people with non-small cell lung carcinoma (nsclc) and 116 studies need Osimertinib + Savolitinib patients."
Answered by AI
Are there any current openings for willing participants in this research?
"The most recent information available on clinicaltrials.gov shows that this study is no longer actively recruiting participants. This particular trial was initially posted on September 28th, 2020 but the last update was on September 7th, 2022. Even though this specific research project is not currently looking for new patients, there are 2,214 other clinical trials that are still open to enrolment."
Answered by AI
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