Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT06083857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2023-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
An Open-Label Phase I/II Study to Evaluate the Safety and prelimiBasnary Efficacy of Amivantamab and Tepotinib Combination in MET-altered Non-small Cell Lung Cancer (NSCLC)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if the combination of amivantamab and tepotinib can help to control NSCLC. The safety of this drug combination will also be studied.
Detailed Description:
Primary Objectives:
1. For the safety run-in portion of the trial:
2. To evaluate dose-limiting toxicity (DLT) and to establish the recommended phase II dose (RP2D) of amivantmab given in combination with tepotinib in patients with advanced MET-altered NSCLC. The primary endpoint is dose-limiting toxicity (DLT) and recommended phase 2 dose (RP2D).
3. For the efficacy portion of the trial:
4. To preliminarily assess efficacy of amivantamab + tepotinib combination in cohort A (MET exon 14 skipping TKI-naïve) , in terms of objective response rate.
Secondary Objectives
1. Determine whether amivantamab + tepotinib improves objective response rate in each cohort (cohort B and cohort C)
2. Determine whether amivantamab + tepotinib improves disease control rate (DCR) in each cohort
3. Determine whether amivantamab + tepotinib improves Duration of Response (DoR) in each cohort
4. Determine the safety and tolerability of amivantamab + tepotinib in each cohort
Exploratory Objectives
1. Explore the association of baseline genomic profiles (from tumor, germline DNA, and ctDNA) with clinical benefit in patients treated with amivantamab + tepotinib
2. Explore resistance mechanisms to amivantamab + tepotinib combination. At the time of progression, patients will undergo ctDNA genomic tests and a biopsy (optional). The purpose of this additional tissue acquisition is for molecular analysis and comparison with the initial specimen, to determine if there are changes in molecular alterations or pathways that shed light on mechanisms of resistance.
3. Determine the immunomodulatory effects of amivantamab + tepotinib combination.
1. For the safety run-in portion of the trial:
2. To evaluate dose-limiting toxicity (DLT) and to establish the recommended phase II dose (RP2D) of amivantmab given in combination with tepotinib in patients with advanced MET-altered NSCLC. The primary endpoint is dose-limiting toxicity (DLT) and recommended phase 2 dose (RP2D).
3. For the efficacy portion of the trial:
4. To preliminarily assess efficacy of amivantamab + tepotinib combination in cohort A (MET exon 14 skipping TKI-naïve) , in terms of objective response rate.
Secondary Objectives
1. Determine whether amivantamab + tepotinib improves objective response rate in each cohort (cohort B and cohort C)
2. Determine whether amivantamab + tepotinib improves disease control rate (DCR) in each cohort
3. Determine whether amivantamab + tepotinib improves Duration of Response (DoR) in each cohort
4. Determine the safety and tolerability of amivantamab + tepotinib in each cohort
Exploratory Objectives
1. Explore the association of baseline genomic profiles (from tumor, germline DNA, and ctDNA) with clinical benefit in patients treated with amivantamab + tepotinib
2. Explore resistance mechanisms to amivantamab + tepotinib combination. At the time of progression, patients will undergo ctDNA genomic tests and a biopsy (optional). The purpose of this additional tissue acquisition is for molecular analysis and comparison with the initial specimen, to determine if there are changes in molecular alterations or pathways that shed light on mechanisms of resistance.
3. Determine the immunomodulatory effects of amivantamab + tepotinib combination.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-08689 | OTHER | NCI-CTRP Clinical Trials Registry | View |