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Clinical Trials List

Protocol NumberD516KC00001
Active

2024-11-27 - 2028-05-29

Phase III

Recruiting10

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants with EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer whose Disease has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林正耀 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Hsin Hsiao
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer

Objectives

To demonstrate the superiority of Dato-DXd monotherapy compared to chemotherapy in terms of PFS.

Test Drug

tablet

Active Ingredient

Dato-DXd
Osimertinib

Dosage Form

N/A
110

Dosage

100mg
80mg

Endpoints

PFS is defined as the time from randomization to
BICR-assessed progression using RECIST v1.1 or death due
to any cause, regardless of whether the participant withdraws
from study therapy, receives other anti-cancer therapy, or
clinical progression. The analysis will include all randomized
participants.
However, if the participant has disease progression or dies
immediately after 2 or more consecutive missed visits, the
participant will be censored at the time of the latest evaluable
assessment prior to the 2 missed visits.
The measure of interest is the HR of PFS.
PFS by investigator will be reported as a sensitivity analysis.

Inclution Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
Age
1 Participant must be ≥ 18 years of age at the time of signing the ICF.
Type of Participant and Disease Characteristics
2 Histologically or cytologically confirmed non-squamous NSCLC. NSCLC of mixed
histology is allowed, as long as not predominantly squamous histology. No small cell or
large cell neuroendocrine components allowed.
3 Must have evidence of documented pre-existing EGFRm information (EGFRm known to
be associated with EGFR TKI-sensitivity [Ex19del, L858R, G719X, S768I, or L861Q],
either alone or in combination with other EGFR mutations, which may include T790M)
taken from medical records.
4 Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as
most recent line of treatment) in the adjuvant, locally advanced (clinical stage IIIB/IIIC
not amenable to curative therapy), or metastatic (clinical stage IVA or IVB) setting, per
Version 9 of the International Association for the Study of Lung Cancer Staging Manual
in Thoracic Oncology.
(a) Participants ongoing on adjuvant osimertinib treatment who recur with locally
advanced (not amenable to curative therapy) or metastatic disease are eligible.
(b) Participants who progressed while receiving osimertinib after definitive
chemoradiotherapy for locally advanced unresectable (stage III) EGFRm NSCLC are
eligible.
(c) Participants who completed neoadjuvant/adjuvant treatment of any type (including
osimertinib) are eligible if they recurred with locally advanced (not amenable to
curative therapy) or metastatic disease, were treated with osimertinib in the locally
advanced/metastatic setting and then subsequently had disease progression while on
osimertinib.
(d) Participants with locally advanced or metastatic disease who progressed on first-line
osimertinib are eligible.
(e) Participants with locally advanced or metastatic disease who were treated with
first- or second-generation EGFR TKI in the first-line setting followed by
progression on osimertinib in the second-line setting are eligible.
5 ≤ 2 prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation
EGFR TKI).
6 If a participant discontinues osimertinib prior to C1D1, they must have no more than
28 days off osimertinib prior to randomization. Post-progression osimertinib monotherapy
is recommended to continue uninterrupted during the screening period up until C1D1 of
study intervention.
7 At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at
baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter
(except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is
suitable for accurate repeated measurements (see Appendix F). If only 1 measurable
lesion exists, it is acceptable to be used (as a TL) as long as it has not been previously
irradiated and as long as it has not been biopsied within 14 days prior to the baseline
tumor assessment scans.
8 WHO/ECOG performance status of 0 or 1.
9 Minimum life expectancy of > 12 weeks at time of screening.
10 Provision of tumor sample (FFPE tumor block or slides) from after progression on
osimertinib, preferably from site of progression, appropriate for exploratory analysis as
described in Section 8.8.1.1.1 and defined in the Laboratory Manual prior to
randomization is highly recommended. If not possible, archival tissue should be provided.
If archival tissue is not available, a discussion with the sponsor is required.
11 Adequate bone marrow reserve and organ function within 7 days before randomization
defined as:
(a) Hemoglobin ≥ 90 g/L (red blood cell/plasma transfusion is not allowed within
2 weeks prior to screening assessment).
(b) Absolute neutrophil count ≥ 1.5 × 109/L (granulocyte colony stimulating factor
administration is not allowed within 1 week prior to screening assessment).
(c) Platelet count ≥ 100 × 109/L (platelet transfusion is not allowed within 10 days prior
to screening assessment).
(d) Serum albumin ≥ 2.5 g/dL.
(e) TBL ≤ 1.5 × ULN or ≤ 3 × ULN in the presence of documented Gilbert’s syndrome
(unconjugated hyperbilirubinemia).

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1 As judged by the investigator, any evidence of diseases (such as severe or uncontrolled
systemic diseases, including active bleeding diseases and significant cardiac or
psychological conditions), history of allogenic organ transplant, and/or substance abuse
which, in the investigator’s opinion, makes it undesirable for the participant to participate
in the study or that would jeopardize compliance with the protocol.
2 Inaccessible veins and/or inability to get a port to receive study intervention via IV
infusion.
3 Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the
formulated product, or previous significant bowel resection that would preclude adequate
absorption, distribution, metabolism, or excretion of osimertinib.
4 Contraindication to brain MRI (preferred) or brain CT with contrast.
5 History of another primary malignancy except for malignancy treated with curative intent
with no known active disease within 2 years before the first dose of study intervention
and of low potential risk for recurrence. Exceptions include adequately resected
nonmelanoma skin cancer (basal cell carcinoma of the skin or squamous cell carcinoma
of the skin), and curatively treated in situ disease.
6 Persistent toxicities caused by previous anti-cancer therapy, excluding alopecia, not yet
improved to Grade ≤ 1 or baseline. Note: participants may be enrolled with some chronic,
stable Grade 2 toxicities (defined as no worsening to > Grade 2 for at least 3 months prior
to the first dose of study intervention and managed with SoC treatment) which the
investigator deems related to previous anti-cancer therapy, including (but not limited to):
(a) Chemotherapy-induced neuropathy.
(b) Fatigue.
(c) Residual toxicities from prior immunotherapy treatment: Grade 1 or Grade 2
endocrinopathies, which may include but are not limited to
hypothyroidism/hyperthyroidism, Type I diabetes, hyperglycemia, adrenal
insufficiency, or adrenalitis; and skin hypopigmentation (vitiligo).
(d) Participants with irreversible toxicity that is not reasonably expected to be
exacerbated by study intervention in the opinion of the investigator may be included
(eg, hearing loss).
7 Unstable spinal cord compression and/or unstable brain metastases. Participants with
spinal cord compression and/or brain metastases that have been stabilized after
completion of local therapy (ie, radiation and/or surgery) and have a stable neurological
status for at least 2 weeks after completion of the local therapy (confirmed by brain MRI)
can be enrolled. Participants must be off steroids prior to start of study intervention.
Participants with asymptomatic brain metastases (including leptomeningeal involvement)
can be eligible for inclusion if, in the opinion of the investigator, immediate definitive
treatment is not indicated.
8 Has significant third-space fluid retention (eg, ascites or pleural effusion) as judged by the
investigator and is not amenable for required repeated drainage.
9 Clinically significant corneal disease.

The Estimated Number of Participants

  • Taiwan

    33 participants

  • Global

    744 participants

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