Savolitinib for Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, Izmir, TurkeyCancer+1 MoreSavolitinib - Drug
Eligibility
18 - 130
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effects of two cancer treatments in people with EGFR-mutated NSCLC that has progressed despite treatment with osimertinib.

Eligible Conditions
  • Cancer
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Osimertinib
1
Lazertinib
1
Alisertib

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Approximately 55 months post first subject randomized

Week 6
Pharmacokinetics (PK) of savolitinib.
Month 55
Disease control rate (DCR) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
Duration of response (DoR) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
Objective response rate (ORR) savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
Overall Survival (OS) / savolitinib in combination with osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed by IHC, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
Participant-reported pulmonary core symptoms / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on osimertinib.
Progression-free survival (PFS) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on osimertinib.
Progression-free survival (PFS) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
Time to discontinuation of treatment (TDT) or death / savolitinib + osimertinib vs platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on osimertinib
Tumor shrinkage / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
Month 55
Overall Survival (OS) /savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Osimertinib
1
Lazertinib
1
Alisertib

Trial Design

2 Treatment Groups

Chemotherapy
1 of 2
Savolitinib + Osimertinib
1 of 2

Active Control

Experimental Treatment

324 Total Participants · 2 Treatment Groups

Primary Treatment: Savolitinib · No Placebo Group · Phase 3

Savolitinib + OsimertinibExperimental Group · 2 Interventions: Savolitinib, Osimertinib · Intervention Types: Drug, Drug
ChemotherapyActiveComparator Group · 3 Interventions: Pemetrexed, Cisplatin, Carboplatin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Savolitinib
2019
Completed Phase 1
~90
Osimertinib
2017
Completed Phase 4
~770

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 55 months post first subject randomized

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,019 Previous Clinical Trials
240,380,824 Total Patients Enrolled
Shun Lu, Prof,MD,PhD,Principal InvestigatorShanghai Chest Hospital, Shanghai JiaoTong University, #241 Huai Hai Road (west), Shanghai, China.

Eligibility Criteria

Age 18 - 130 · All Participants · 10 Total Inclusion Criteria

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

Frequently Asked Questions

When might Savolitinib be cleared for public use in the United States?

"Savolitinib was given a safety score of 3. This is because it is a Phase 3 trial, so there is already some evidence that the drug works and that it doesn't cause too many adverse effects." - Anonymous Online Contributor

Unverified Answer

Are there several hospitals running this study in different cities?

"To make participating in this trial as convenient as possible for patients, the locations have been spread out across 14 different sites. Some of these include Nashville, Orlando and Evergreen Park." - Anonymous Online Contributor

Unverified Answer

Are those under the age of 65 years old able to participate in this research?

"This study includes patients that are aged 18 or older, with the maximum age limit set at 130 years old." - Anonymous Online Contributor

Unverified Answer

Which patients would be a good fit for this clinical trial?

"This study is enrolling 324 people with carcinoma aged 18 and 130. Most notable, patients are required to meet the following criteria: • Participant must be ≥18 years (≥ 20 years of age in Japan) at the time of signing the informed consent. All genders are permitted.• Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.• Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy.• Mandatory provision of FFPE tumour" - Anonymous Online Contributor

Unverified Answer

Are researchers looking for more participants in this trial?

"This trial is still recruiting patients, if you are interested. The listing on clinicaltrials.gov shows that the study was first posted on 8/3/2022 and has been edited most recently on 11/7/2022." - Anonymous Online Contributor

Unverified Answer

How many people are enrolled in the trial?

"In order to move forward with this study, we need 324 individuals who meet the pre-determined inclusion criteria. These patients will be recruited from different locations such as Research Site in Nashville, Tennessee and Rutgers Cancer Institute of New Jersey (CINJ) in Orlando, Illinois." - 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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