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osimertinib for Cancer

Research Site, Padova, Italy
Cancerosimertinib - Drug
Eligibility
18+
All Sexes

Study Summary

This trial will test whether adding savolitinib to osimertinib can help patients with EGFRm+ and MET+ NSCLC that has progressed after osimertinib treatment.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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2
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Study Objectives

1 Primary · 18 Secondary · Reporting Duration: Blood samples collected at Screening within 28 days before the first dose of study treatment; on day of first dose of study treatment; at discontinuation 7 days after last dose of study treatment. (One cycle = 28 days)

Day 28
Longitudinal changes in circulating DNA and/or RNA compared with PFS, OS and ORR.
Day 28
Plasma concentrations of osimertinib, savolitinib and their metabolites.
Month 36
AEs, SAEs and discontinuation rate due to AEs, as characterized and graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v5.
Month 36
EQ-5D-5L
Preolivary nucleus
Patient's Global Impression of Severity (PGIS)
Month 36
Therapeutic procedure
Total clearance in EGFR mutations at 6-weeks after therapy initiation (percentage and absolute change from baseline in EGFR mutation allele frequencies).
Day 28
HLA alleles associated with susceptibility to drug related AEs (such as but not limited to hypersensitivity).
Day 28
Pharmacogenetic analyses on blood samples.
Day 28
Disease relevant or response markers in tumour tissue and circulating tumour DNA/RNA including but not limited to EGFR mutations and MET amplifications.
Month 6
Objective response rate (ORR) by investigator assessment in accordance with RECIST 1.1
Month 15
CNS PFS by BICR assessments in accordance with RECIST 1.1
Duration of Response (DoR) assessed by BICR in accordance with RECIST 1.1
Duration of Response (DoR) by investigator assessment in accordance with RECIST 1.1.
Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30).
Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) complementary 13-item quality-of-life questionnaire - lung cancer symptoms questionnaire (QLQ-LC13).
Objective response rate (ORR) assessed by BICR in accordance with RECIST 1.1
Objective response rate (ORR) by investigator assessment in accordance with RECIST 1.1.
Overall Survival (OS) by all cause mortality.
Progression-free survival (PFS) assessed by BICR in accordance with RECIST 1.1
Progression-free survival (PFS) by investigator assessment in accordance with RECIST 1.1.
The presence/absence of CNS lesions at progression by BICR assessments in accordance with RECIST 1.1
Month 36
Duration of Response by investigator assessment in accordance with RECIST 1.1.
Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30), version 3 (QLQ-C30 v3).
Overall Survival by investigator assessment in accordance with RECIST 1.1.
PFS by investigator assessment in accordance with RECIST 1.1.
Percentage change in tumour size by investigator assessment in accordance with RECIST 1.1.

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
SOT102
3
Bemarituzumab
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Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

osimertinib + savolitinib
1 of 2
placebo + savolitinib
1 of 2

Experimental Treatment

Non-Treatment Group

360 Total Participants · 2 Treatment Groups

Primary Treatment: osimertinib · Has Placebo Group · Phase 2

osimertinib + savolitinibExperimental Group · 2 Interventions: osimertinib, savolitinib · Intervention Types: Drug, Drug
placebo + savolitinibPlaceboComparator Group · 2 Interventions: placebo, savolitinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: blood samples collected at screening within 28 days before the first dose of study treatment; on day of first dose of study treatment; at discontinuation 7 days after last dose of study treatment. (one cycle = 28 days)

Who is running the clinical trial?

Hutchison MediPharmaUNKNOWN
AstraZenecaLead Sponsor
4,057 Previous Clinical Trials
240,403,564 Total Patients Enrolled
Lecia V Sequist, MD MPHPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
30 Total Patients Enrolled
Myung-Ju Ahn, MDPrincipal InvestigatorSamsung Medical Centre Sungkyunkwan University School of Medicine
2 Previous Clinical Trials
629 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

How many healthcare facilities are hosting this research experiment?

"This trial is currently available at 13 medical locations, including Toronto, La Jolla and Brooklyn. To minimize travel requirements for participants, it's best to select the clinic nearest your residence." - Anonymous Online Contributor

Unverified Answer

Has osimertinib received the regulatory green light from the FDA?

"Our team's appraisal of osimertinib's safety yielded a rating of 2, as data exists to back up its protection but it has yet to be determined if the medication is effective." - Anonymous Online Contributor

Unverified Answer

Are there still open slots available for participants in this research endeavor?

"Affirmative, according to the information posted on clinicaltrials.gov this medical trial is accepting patients. The study debuted on September 1st 2019 and was last modified November 28th 2022. Recruitment of 360 individuals from 13 sites is required for completion of the trial." - Anonymous Online Contributor

Unverified Answer

Have there been any precedential investigations related to osimertinib?

"Osimertinib was first trialed in 2013 at Research Site, and now boasts 2734 completed studies. Of the 112 active investigations of this medication, many are situated around Toronto, Ontario." - Anonymous Online Contributor

Unverified Answer

Is this a pioneering trial that is attempting to break new ground?

"Currently, 112 clinical trials for osimertinib are being conducted in 1080 cities and 51 countries. Since its first trial sponsored by AstraZeneca commenced in 2013 with 603 participants, 2734 studies have been successfully completed." - Anonymous Online Contributor

Unverified Answer

How many individuals are joining this research endeavor?

"Affirmative. Information available on clinicaltrials.gov indicates that this trial is actively enrolling, with the first listing posted on September 1st 2019 and most recently updated in November 28th 2022. The research project aims to recruit 360 patients from 13 different medical centres." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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