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Joint Clinical Trials Office

A Phase III, Open-label, Randomised Study of Osimertinib With or Without Dato-DXd as First-line Treatment in Participants With Epidermal Growth Factor Receptor Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer

Clinical Trial Details

This clinical trial is for adults who have been diagnosed with non-small cell lung cancer (NSCLC).

The main purpose of this research is to learn more about whether treatment with osimertinib in combination with Dato-DXd is superior to osimertinib alone for the first-line treatment of participants with Epidermal Growth Factor Receptor (EGFR) mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
   
Osimertinib is approved by the U.S. Food and Drug Administration (FDA) for the treatment of EGFR mutation-positive, locally advanced or metastatic NSCLC. However, the use of the osimertinib in combination with Dato-DXd is experimental and not approved for the treatment of EGFR mutation-positive, locally advanced or metastatic NSCLC.
   
Dato-DXd is a new type of anti-cancer drug called an “antibody drug conjugate” (ADC) that targets cancer cells expressing a high level of a specific surface molecule.
   
During the treatment period, participants will be randomly assigned by chance to receive osimertinib with Dato-DXd or osimertinib without Dato-DXd. Participants have a 50% chance of being given the combination of osimertinib and Dato-DXd.
   
Osimertinib is a tablet taken once a day by mouth. Dato-DXd is given as an infusion into a vein every 3 weeks.
   
This study involves screening, treatment and follow up (after study treatment is discontinued) periods. Participants will have about 50 visits over 3 years for the treatment period. The visits will usually last about 2 hours. Treatment will continue until disease progression, unacceptable side effects, or another discontinuation criterion is met.

Key Eligibility: 
  1. Male or female aged 18 years or older.
  2. Must have histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed histology is allowed if adenocarcinoma is the predominant histology. Mixed small-cell lung cancer and NSCLC histology, and sarcomatoid variant of NSCLC is ineligible.
  3. Must have Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC not amenable to curative surgery or definitive chemoradiation at the time of randomization.
  4. Participants must not have received prior EGFR TKIs or other systemic therapy for Stage IIIB, IIIC or IV NSCLC. Prior adjuvant and/or neo-adjuvant therapies (target therapy, chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including target therapy, biologic therapy, investigational agents, are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease. 

Detailed eligibility reviewed when participants contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Amie Patel, RN
212-746-1480
amp3002@med.cornell.edu

Brooklyn

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Ashish Saxena, MD, PhD  (UES)

Andy Y. Huang, MD  (BRK)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2506028976

ClinicalTrials.gov:

NCT06350097

Sponsor:

D516NC00001

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • AstraZeneca

Disease

Lung Cancer
Non-Small Cell Lung Cancer