NCI-2024-05588

A Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants with Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in the AdjuvanT Setting (INSIGHT)

The INSIGHT study is a Phase III, randomized research study investigating how to optimize immunotherapy for patients with early-stage non-small cell lung cancer (NSCLC) after surgery, also known as the adjuvant setting. This study focuses on patients who have undergone surgical removal of their lung tumors and aims to determine whether the pathologic complete response (pCR) — meaning no detectable cancer cells remaining in tissue samples after treatment — can be used as a key indicator to guide and personalize immunotherapy use. Participants are randomly assigned to different adjuvant treatment strategies involving immunotherapy drugs (such as PD-1 or PD-L1 checkpoint inhibitors) either alone or in combination with standard care approaches like chemotherapy. The study compares how these treatments affect recurrence-free survival (RFS), overall survival (OS), and quality of life, while also studying how early immune responses and pCR rates predict long-term outcomes.

By incorporating pCR as an early endpoint, the INSIGHT trial aims to improve treatment decision-making — helping doctors identify which patients benefit most from continued or intensified immunotherapy after surgery, potentially reducing overtreatment and improving cure rates in early-stage NSCLC.

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

non-small cell lung cancer (NSCLC): A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Check point inhibitor: The immune system can help fight cancer. Drugs called “checkpoint inhibitors” work by releasing a natural brake on your immune system so that immune cells can recognize and attack tumors.

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

https://clinicaltrials.gov/ct2/show/NCT06498635

Clinical Trial Site: Einstein

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