Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer

Running, not enrolling · Phase 1

Conditions studied: Advanced or Metastatic NSCLC

In brief

This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy with or without carboplatin in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

Key facts

Study ID: NCT04612751
Run by: AstraZeneca
People needed: 155
Starts: 2021-02-02
Expected to finish: 2027-05-04
Last updated by the study team: 2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant ≥18 years old on the day of signing the ICF (local regulatory requirement to consent should be followed).
Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC, without EGFR or ALK genomic alterations (testing not required for participants with documented squamous histology) and no known genomic alterations in other actionable driver kinases with approved therapies. Participants whose tumors harbor KRAS mutations are eligible for this study.
For Cohorts 1 to 4, participants must be treatment-naïve or have received and radiologically progressed after only 1 prior line of systemic chemotherapy, without concomitant immune checkpoint inhibitors for advanced or metastatic NSCLC. For Cohorts 4a, 5 to 11, and 14, participants must be treatment-naïve for advanced or metastatic NSCLC. For Cohorts 12 to 13, participants must be CPI acquired resistant after 1 or 2 prior lines of systemic therapy for advanced or metastatic NSCLC, of which 1 should have contained an approved anti-PD-1/PD L1. Cohort 4a will enroll participants whose tumors have squamous histology only; Cohorts 5 Part 2A and Part 2B as well as Cohorts 12 and 13 will enroll participants whose tumors have non-squamous histology only.
Willing and able to undergo a mandatory tumor biopsy. A tumor biopsy that was recently collected (within 3 months of screening) after completion of the most recent anticancer treatment regimen may be substituted for the biopsy collected during screening. For Cohorts 12 and 13, a tumor sample taken ≤24 months prior to screening is acceptable.
Has measurable disease per RECIST1.1 within 28 days prior to Cycle 1 Day 1
Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 at screening
Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 day 1
For Cohorts 5 to 14 only: Documented IHC PD-L1 expression per analytically validated Ventana PD-L1 (SP263) IHC assay, 22C3 PharmDx assay, or 28-8 PharmDx assay

You may not qualify if…

Active or prior documented autoimmune or inflammatory disorders
Uncontrolled or significant cardiac disease
History of another primary malignancy with exceptions
active or uncontrolled hepatitis B or C virus or uncontrolled HIV infection
spinal cord compression or clinically active CNS metastases
History of (non-infectious) ILD/pneumonitis that required steroids
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illness
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
Clinically significant corneal disease

Where it is running

Research Site — La Jolla, California, United States
Research Site — Santa Ana, California, United States
Research Site — St Louis, Missouri, United States
Research Site — Hackensack, New Jersey, United States
Research Site — Cleveland, Ohio, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Dallas, Texas, United States
Research Site — Houston, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — Fairfax, Virginia, United States
Research Site — Hasselt, Belgium
Research Site — Roeselare, Belgium
Research Site — Aviano, Italy
Research Site — Meldola, Italy
Research Site — Orbassano, Italy
Research Site — Roma, Italy
Research Site — Kōtoku, Japan
Research Site — Sunto-gun, Japan
Research Site — Yokohama, Japan
Research Site — Gdansk, Poland
Research Site — Lodz, Poland
Research Site — Lublin, Poland
Research Site — Warsaw, Poland
Research Site — A Coruña, Spain
Research Site — Badalona, Spain

Full record on ClinicalTrials.gov

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