Study on AZD2936 for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT04995523

Provider View

This clinical trial is testing a new treatment called AZD2936, which is a bispecific antibody targeting TIGIT and PD-1, to see if it is safe and effective for people with advanced or metastatic non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new drug, AZD2936, in adults with advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation. The trial is divided into several parts to test different doses and treatment plans.

Description

This clinical trial is the first time AZD2936 is being tested in humans. It is an open-label study, meaning both the researchers and participants know what treatment is being given. The study is conducted at multiple centers and involves several parts:

  • Part A focuses on finding the right dose of AZD2936.
  • Parts B to E expand on the dose to see how well it works in different groups of patients.

Participants will receive AZD2936 to see how their bodies respond to the treatment, including how it is processed and its effects on the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be 18 years or older.
  • For Parts A and B: Have stage III or IV NSCLC that cannot be treated with surgery or radiation.
  • For Parts C and D: Have stage IV NSCLC with no prior immune therapy for metastatic cancer.
  • For Part E: Have stage IV squamous NSCLC with no prior treatment for metastatic cancer.
  • Must have a specific protein (PD-L1) present in the cancer cells.
  • For Parts A and B: Cancer must have progressed during previous treatment with a specific type of therapy.
  • Must have a performance status indicating they are fully active or have some restrictions but can still do light work.
  • Must have a life expectancy of at least 12 weeks.
  • Must have at least one tumor that can be measured.
  • Must have adequate bone marrow, liver, and kidney function.

Exclusion Criteria

  • Have certain genetic mutations or alterations for which other treatments are available.
  • Have received previous treatment with anti-TIGIT therapy.
  • Are currently receiving other cancer treatments.
  • For Parts A and B: Have resistance to two or more previous treatments.
  • For Parts C and D: Have had previous immune therapy for metastatic NSCLC.
  • For Part E: Have had any previous treatment for metastatic NSCLC.
  • Have cancer that has spread to the brain and is causing symptoms.
  • Have had a blood clot within the last 3 months.
  • Have had another invasive cancer within the last 2 years.

Locations

FACILITYZIPCITYSTATE
Research Site92868OrangeCalifornia
Research Site60637ChicagoIllinois
Research Site21201BaltimoreMaryland
Research Site55905RochesterMinnesota
Research Site77030HoustonTexas
Research Site22031FairfaxVirginia

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.