Study on Datopotamab Deruxtecan and Pembrolizumab With or Without Chemotherapy for First-Line Treatment of Non-Small Cell Lung Cancer

Sponsor: Daiichi Sankyo

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05555732

Provider View

This clinical trial is testing a new combination of drugs, including datopotamab deruxtecan and pembrolizumab, with or without chemotherapy, to see if they are safe and effective for patients with advanced non-small cell lung cancer who have not received prior treatment.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of a new drug combination for patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have not been treated before. Participants will be randomly assigned to receive either datopotamab deruxtecan with pembrolizumab and platinum chemotherapy, datopotamab deruxtecan with pembrolizumab, or pembrolizumab with pemetrexed and platinum chemotherapy. The study will include a screening period, a treatment period, and a follow-up period.

Description

The main goals of this study are to see how long patients live without their cancer getting worse (Progression Free Survival) and how long they live overall (Overall Survival) when treated with these new drug combinations as a first-line therapy. Participants must have a specific type of lung cancer that does not have certain genetic changes and a PD-L1 score of less than 50%.

Participants will be divided into three groups: one group will receive datopotamab deruxtecan with pembrolizumab and platinum chemotherapy, another group will receive datopotamab deruxtecan with pembrolizumab, and the third group will receive pembrolizumab with pemetrexed and platinum chemotherapy. The type of platinum chemotherapy (carboplatin or cisplatin) will be decided by the study doctor. The study will have three phases: a screening phase to check eligibility, a treatment phase where participants receive the study drugs, and a follow-up phase to monitor health outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must sign a consent form before any study procedures.
  • Adults aged 18 or older.
  • Have a tumor with a PD-L1 score of less than 50%.
  • Provide a tumor sample for testing.
  • Have not received treatment for advanced or metastatic non-squamous NSCLC.
  • Have measurable disease based on scans.
  • Have a specific type of NSCLC that cannot be treated with surgery or radiation, or has spread to other parts of the body.
  • No genetic changes in certain cancer-related genes.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have an adequate break from previous treatments before starting the study.
  • Willing to participate in patient-reported outcomes data collection.

Exclusion Criteria

  • Have received prior treatment for advanced/metastatic NSCLC.
  • Have received certain types of cancer treatments before.
  • Have received a live vaccine within 30 days before the study.
  • Have untreated or active cancer spread to the brain or spinal cord.
  • Have uncontrolled heart disease or other serious health conditions.
  • Have severe lung disease or breathing problems.
  • Have a weakened immune system or are on long-term steroid treatment.
  • Have another active cancer, except for certain types that are not likely to spread.
  • Have severe allergies to study drugs or similar medications.
  • Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Are pregnant, breastfeeding, or planning to become pregnant.
  • Have other medical conditions that could interfere with the study.
  • Have a history of lung disease that required steroids or have current lung disease.
  • Have an active autoimmune disease.
  • Have significant eye disease.
  • Have had an organ transplant.
  • Have had recent radiation therapy to the lung.

Get This Program In Your Inbox

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