NCT-06396065

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

This Phase 3 randomized, double-blind, multi-center study evaluates the efficacy and safety of AK112 or placebo combined with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed prior EGFR TKI treatment.

Phase 3: A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment

randomized: Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

double-blind: Neither the patients nor the doctors know who is getting what treatment. This helps make sure the results are completely not biased

EGFR: Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

locally advanced: Cancer which has grown larger into nearby tissues or organs, but hasn’t moved far from where it started

metastatic: cancer that has spread from its original location or organ to other parts of the body.

non-squamous NSCLC:  a type of lung cancer that isn’t made up of squamous cells. Instead, it includes other types of cells like those found in the outer parts of the lung or in the glandular tissues. It generally grows and spreads differently from squamous cell lung cancer.

TKI: Tyrosine kinase inhibitors (TKI) block chemical messengers (enzymes) called tyrosine kinases which stop growth signals in cells. TKIs pause cells from growing and dividing.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT06396065

Clinical Trial Site: Sinai

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