Phase 3 Clinical Study of AK112 for NSCLC Patients
Research type
Research Study
Full title
A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment (HARMONi)
IRAS ID
1007763
Contact name
Mary Habib
Contact email
Sponsor organisation
Summit Therapeutics Sub Inc
Clinicaltrials.gov Identifier
Research summary
The purpose of this research is to measure the safety and effectiveness of ivonescimab (a new drug) to treat certain types of non-small cell lung cancer when they become unresponsive to medications that are already approved for use/on the market.
Ivonescimab is an antibody. Antibodies are substances that occur naturally in the body and help fight infection. Ivonescimab blocks two proteins in the body that help cancer cells live, grow, and spread. It is possible that the study drug may slow the growth and spread of cancer cells.
This is an international study and approximately 470 patients will be enrolled. Patients can be male or female between 18 and 75 years old, those who consent to take part in the study will be screened to make sure they meet specific criteria. Enrolled patients will be put in to one of two treatment groups. In group A patients will be given ivonescimab together with the approved caner drugs carboplatin and pemetrexed whilst patients in group B will be given a placebo (no active drug) together with carboplatin and pemetrexed. Patients will visit the clinic every three weeks for treatment and different types of test e.g. blood tests, scans and ECGs. The treatment may continue for up to 24 months.
The progression of the patients’ non-small cell lung cancer, and the general health of the patients, will be compared between the two groups.REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0780
Date of REC Opinion
5 Dec 2023
REC opinion
Further Information Favourable Opinion