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RECRUITINGPHASE1/PHASE2

Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression

A Prospective Study of Savolitinib Plus Docetaxel in Pretreated EGFR/ALK/ROS1/MET ex14m-wildtype Advanced NSCLC Patients With MET Overexpression (FirstMET)

NCT05777278•The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

This is a prospective, pilot, single-arm, single-center study exploring the efficacy and safety of savolitinib plus docetaxel as second-line therapy in patients with MET overexpressed, EGFR/ALK/ROS1/MET ex14m-wildtype advanced NSCLC. Participants will receive treatment of docetaxel (60 mg/m2, ivgtt, q3w) in combination with savolitinib (300mg or 200mg according to safety run-in recommendation, p.o., BID) after informed consent signed. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.
•3. Female or males age ≥18 years at the time of signing the ICF.
•4. Histologically or cytologically confirmed locally advanced or metastatic EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC.
•5. Has only received first line systemic treatment of non-targeted advanced NSCLC.
•* Prior MET inhibitor therapy is not allowed.
•* At least 28 days since last treatment.
•6. MET overexpression as determined IHC on tumor tissue.
•* MET overexpression by IHC, 3+ in ≥50% of tumor cells
•* Local IHC results are acceptable.
+50 more criteria

Exclusion Criteria

•1. As judged by the investigator, active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhoea Grade ≥2, and malabsorption syndrome).
•2. Any of the following cardiac diseases currently or within the last 6 months:
•* Unstable angina pectoris
•* Congestive heart failure (New York Heart Association \[NYHA\] ≥Grade 2)
•* Acute myocardial infarction
•* Stroke or transient ischemic attack
•3. Uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy).
•4. Mean resting correct QT interval (QTcF) \>470 msec for women and \>450 msec for men on screening obtained from 3 electrocardiograms (ECGs) or factors that may increase the risk of QTcF prolongation such as chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.
•5. Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiograms (ECGs), e.g. complete left bundle branch block, third degree heart block, second degree heart block, PR interval \>250 msec.
•6. Serious underlying medical condition at the time of treatment that would impair the ability of the patient to receive protocol treatment.
+3 more criteria

Locations (1)

Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Key Dates

Start Date

July 26, 2023

Primary Completion Date

August 31, 2027

Completion Date

August 31, 2027

Last Updated

October 10, 2023

Enrollment

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer

Interventions

Savolitinib

DRUG

Docetaxel

DRUG

Contacts

Jianxing He, M.D

CONTACT

+86-20-83337792 drjianxing.he@gmail.com

Wenhua Liang, M.D

CONTACT

+86-13710249454 liangwh1987@163.com

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)