Lung Cancer Clinical Trial

Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab With or Without Carboplatin in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung04)

Summary

This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with durvalumab in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

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Full Description

The primary objective of this study will assess the safety and tolerability of datopotamab deruxtecan (Dato-DXd) in combination with durvalumab with or without 4 cycles of carboplatin in participants with advanced or metastatic NSCLC who have either been previously treated or are treatment naïve in a metastatic setting.

Two dose levels of Dato-DXd (4.0 mg/kg and 6.0 mg/kg) will be studied in combination with fixed-dose durvalumab (1120mg), with or without 4 cycles of carboplatin in 4 study cohorts. This study will be conducted sequentially and dose escalation will occur according to lower dose to higher dose in the same combination regimen (4.0 mg/kg to 6.0 mg/kg) and from 2-drug combination (Dato-DXd and durvalumab) to 3-drug combination regimen (Dato-DXd, durvalumab, and carboplatin).

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Eligibility Criteria

Inclusion Criteria:

Subject ≥18 years old on the day of signing the ICF (local regulatory requirements to consent should be followed).
Advanced or metastatic NSCLC, histologically confirmed at diagnosis of NSCLC, documented negative test results for EGFR and ALK genomic alterations, and no known genomic alterations in ROS1, NTRK, BRAF, RET, MET, or other actionable driver kinases with approved therapies (actionable genomic alterations).
Is not a candidate for surgical resection or chemoradiation with curative intent.
Documentation of radiological disease progression while on or after receiving the most recent treatment regimen, if any, for advanced or metastatic NSCLC.
Must be treatment-naïve or have received only 1 prior line of systemic chemotherapy, without concomitant immune checkpoint inhibitors (ICIs) including anti- PD-1/PD-L1, anti-PD-L2, and anti-CTLA-4 for advanced or metastatic NSCLC.
Willing and able to undergo a mandatory tumor biopsy. There is no requirement for PD-L1 protein expression for inclusion.
Archival tumor tissue from initial diagnosis, to the extent that archival tumor tissue is available, for measurement of TROP2 expression levels or other biomarkers.
Eastern Cooperative Oncology Group performance status (ECOG PS) 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.

Exclusion Criteria:

Experienced grade 3 or higher immune-related adverse events with prior immunotherapy treatment.
Received a live vaccine within 30 days prior to the first dose of study treatment.
Active, known, or suspected autoimmune disease.
Has a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day 1.
Prior allogenic organ transplantation.
Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or durvalumab, and carboplatin for participants to be enrolled in relevant cohorts.
Uncontrolled or significant cardiac disease.
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Known human immunodeficiency virus (HIV) infection that is not well controlled.
Active hepatitis or uncontrolled hepatitis B or C infection; is positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen [HBsAg], hepatitis B surface antibody [anti-HBs], hepatitis B core antibody [anti-HBc, or hepatitis B virus [HBV] DNA) or hepatitis C (HCV antibody OR HCV RNA) infection.
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.

History of another primary malignancy, (beyond NSCLC) except for:

Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study treatment and of low potential risk for recurrence.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated carcinoma in situ without evidence of disease.
Participants with a history of prostate cancer.
Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 Grade ≤1 or baseline.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

68

Study ID:

NCT04612751

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 16 Locations for this study

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Research Site
Santa Ana California, 92705, United States
Research Site
Chicago Illinois, 60637, United States
Research Site
Saint Louis Missouri, 63110, United States
Research Site
Hackensack New Jersey, 07601, United States
Research Site
Cleveland Ohio, 44106, United States
Research Site
Philadelphia Pennsylvania, 19111, United States
Research Site
Dallas Texas, 75230, United States
Research Site
Houston Texas, 77030, United States
Research Site
San Antonio Texas, 78229, United States
Research Site
Fairfax Virginia, 22031, United States
Research Site
Hasselt , 3500, Belgium
Research Site
Mechelen , 2800, Belgium
Research Site
Paris Cedex 05 , 75248, France
Research Site
Koto-ku , 135-8, Japan
Research Site
Sunto-gun , 411-8, Japan
Research Site
Yokohama-shi , 241-8, Japan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

68

Study ID:

NCT04612751

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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