METalmark
Research type
Research Study
Full title
A Phase 1/2 Open-label Platform Study to Evaluate the Safety and Efficacy of Multiple Amivantamab-based Therapeutic Combinations in Participants with Advanced, Unresectable Lung Cancer (LC)
IRAS ID
1006057
Contact name
Tunde Adeyele
Contact email
Eudract number
2022-500729-34
ISRCTN Number
ISRCTN23584582
Clinicaltrials.gov Identifier
Research summary
This is a phase 1/2 study evaluating the safety and efficacy of amivantamab and capmatinib (the study drugs) in unresectable metastatic non-small cell lung cancer in adult participants with mesenchymal-epithelial transition (MET) exon 14 skipping mutations and MET amplification.
MET, a type of antigen (protein), can be found on cancer cells. In laboratory studies, amivantamab binds to MET on a cancer cell, and the cell cannot get the signals it needs to grow.
This study will have 2 parts. For the first part (Phase 1), different doses of the study drugs will be tested to establish a safe dose combination. Once a safe combination of the study drugs is established, additional groups of patients will be enrolled in Phase 2 to better establish the safety and effectiveness of the drug combination. Participants in Phase 2 will be enrolled into one of three cohorts, depending on their disease status and past treatment(s).
All participants will receive both study drugs. Amivantamab is delivered intravenously (i.e., into a vein). Capmatinib is an oral tablet.
The study consists of a Screening period of up to 28 days, a Treatment period consisting of 28-day cycles and an End of Treatment visit, and a Follow-up period.
This protocol is an Investigation-specific appendix (ISA) to the platform trial KALEIDOSCOPE (Protocol PLATFORMPANSC2001). Participants must consent to both the platform trial and this ISA.
REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0637
Date of REC Opinion
22 Dec 2022
REC opinion
Further Information Favourable Opinion