Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer

Sponsor: ImmunityBio, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03520686

Provider View

This clinical trial is testing a new treatment called Nogapendekin Alfa Inbakicept for patients with advanced non-small cell lung cancer (NSCLC). The study aims to see if this treatment can improve outcomes when added to standard therapies. Participants will be divided into different groups based on their cancer characteristics and previous treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced non-small cell lung cancer (NSCLC) called Nogapendekin Alfa Inbakicept. The trial is divided into four groups, each receiving different treatments based on their cancer type and previous therapies. The goal is to see if adding this new treatment can improve patient outcomes. Participants will be monitored for up to two years to track their progress and any side effects.

Description

The trial involves four groups of patients, each with different cancer characteristics and treatment histories. The study aims to determine if adding Nogapendekin Alfa Inbakicept to the first-line treatment for advanced NSCLC can improve outcomes. Participants will be monitored for disease progression and overall survival for up to two years. The study will also explore how the treatment affects different types of NSCLC.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to understand and sign a consent form.
  • Have stage 3 or 4 non-small cell lung cancer (NSCLC) that cannot be treated with surgery or chemoradiation.
  • Must not have received prior chemotherapy for advanced NSCLC, except under specific conditions.
  • For certain groups, tumors must show specific markers (PD-L1 expression).
  • Tumors must not have certain genetic mutations (EGFR, ALK, BRAF, ROS1, NTRK).
  • Must have a performance status of 0 or 1, indicating good overall health.
  • Must have measurable tumors.
  • Willing to provide tumor samples and blood samples for research.
  • Must agree to use effective contraception during and after the study.

Exclusion Criteria

  • Have serious uncontrolled diseases that could interfere with the study.
  • Have had another cancer within the last 3 years, with some exceptions.
  • Have autoimmune diseases requiring treatment.
  • Have had an organ transplant or certain lung diseases.
  • Have received certain treatments recently, such as chemotherapy or major surgery.
  • Have untreated brain metastases or certain infections.
  • Have inadequate organ function based on specific lab tests.
  • Have uncontrolled high blood pressure or heart disease.
  • Have breathing difficulties requiring oxygen.
  • Have allergies to study medications.
  • Are pregnant or breastfeeding.
  • Are unable to comply with study requirements.

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