DS-1062a compared to Docetaxel in pretreated advanced or metastatic non-small cell lung cancer

Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hong Kong, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States (ICTRP)

ICTRP Studien-ID
NCT04656652 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer with or without Actionable Genomic Alterations (TROPIONLUNG01) (BASEC)

Wissenschaftlicher Titel
Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01) (ICTRP)

Öffentlicher Titel
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) (ICTRP)

Untersuchte Krankheit(en)
Non-small Cell Lung Cancer (ICTRP)

Untersuchte Intervention
Drug: DS-1062aDrug: Docetaxel (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Ein-/Ausschlusskriterien
Inclusion Criteria:

Participants eligible for inclusion in the study must meet all inclusion criteria within
28 days of randomization into the study.

- Sign and date the inform consent form (ICF) prior to the start of any study specific
qualification procedures.

- Adults =18 years (if the legal age of consent is >18 years old, then follow local
regulatory requirements)

- Life expectancy =3 months

- Has pathologically documented Stage IIIB, IIIC, or stage IV NSCLC disease with or
without actionable genomic alterations (AGA) at the time of randomization (based on
the American Joint Committee on Cancer, Eighth Edition) and meets following criteria
for NSCLC:

- Participants without AGA:

1. Must have documented negative test results for epidermal growth factor receptor
(EGFR) and anaplastic lymphoma kinase (ALK).

2. Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1),
neurotrophic tyrosine receptor kinase (NTRK), proto oncogene B-raf (BRAF),
mesenchymal-epithelial transition (MET) exon 14 skipping, or rearranged during
transfection (RET).

- Participants with AGA must have one or more documented actionable genomic
alteration(s): EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.

- Has documentation of radiographic disease progression while on or after receiving
the most recent treatment regimen for advanced or metastatic NSCLC.

- Participant without AGA must meet 1 of the following prior therapy requirements for
advanced or metastatic NSCLC:

1. Received platinum-based chemotherapy in combination with a-PD-1/a-PD-L1
monoclonal antibody as the only prior line of therapy.

- Includes participants who received prior platinum-based/chemotherapy with
or without radiotherapy with maintenance a-PD-1/a-PD-L1 monoclonal
antibody for Stage III disease and relapsed/progressed within 6 months
from the last dose of platinum-based chemotherapy.

- Includes participants who received prior platinum-based/chemotherapy with
or without radiotherapy (with or without maintenance a-PD-1/a-PD-L1
monoclonal antibody) for Stage III disease and subsequently received
a-PD-1/a-PD-L1 monoclonal antibody therapy (with or without platinum-based
chemotherapy) for recurrent disease.

2. Received platinum-based chemotherapy and a-PD-1/a-PD-L1 monoclonal antibody (in
either order) sequentially as the only 2 prior lines of therapy.

- Participants with AGA must meet the following for advanced or metastatic NSCLC:

1. Participants who have been treated with 1 or 2 prior lines of applicable
targeted therapy that is locally approved for the participant's genomic
alteration at the time of screening

- Participants who have tumors with EGFR L858R or exon 19 deletion mutations
must have received prior Osimertinib.

- Those who received a targeted agent as adjuvant therapy for early-stage
disease must have relapsed or progressed while on the treatment or within
6 months of the last dose OR received at least one additional course of
targeted therapy for the same genomic alteration (which may or may not be
same agent used in the adjuvant setting) for relapsed/progressive disease.

- Participants who have been treated with a prior tyrosine kinase inhibitor
(TKI ) must receive additional approved targeted therapy, if locally
available and clinically appropriate, for the applicable genomic
alteration, or the participant will not be allowed in the study.

2. Participants who have received platinum-based chemotherapy as the only prior
line of cytotoxic therapy:

- One platinum-containing regimen for advanced disease

- Those who received a platinum-containing regimen as adjuvant therapy for
early-stage disease must have relapsed or progressed while on the
treatment or within 6 months of the last dose OR received at least one
additional course of platinum-containing therapy (which may or may not be
same as in the adjuvant setting) for relapsed/progressive disease.

3. May have received up to one a-PD-1/a-PD-L1 monoclonal antibody alone or in
combination with a cytotoxic agent.

- Must undergo a pre-treatment tumor biopsy procedure or if available, tumor tissue
previously retrieved from a biopsy procedure performed within 2 years prior to the
participant signing informed consent and that has a minimum of 10 4 micron
sections or a tissue block equivalent of 10 4 micron sections may be substituted
for the pre-treatment biopsy procedure during Screening. If a documented law or
regulation prohibits (or does not approve) sample collection, then such samples will
not be collected/submitted

- Measurable disease based on local imaging assessment using RECIST v1.1

- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at
Screening

- Within 7 days before randomization, has adequate bone marrow, hepatic, and renal
function

- Left ventricular ejection fraction (LVEF) =50% by either echocardiogram (ECHO) or
multigated acquisition (MUGA) scan within 28 days before randomization

- Adequate blood clotting function defined as international normalized
ratio/prothrombin time and either partial thromboplastin or activated partial
thromboplastin time =1.5 upper limit of normal (ULN)

- Adequate treatment washout period before randomization

- Females of childbearing potential must have a negative serum pregnancy test at
screening and must be willing to use highly effective birth control from the time of
enrollment up to 7 months after the last dose of DS-1062a or for at least 6 months
after the last dose of docetaxel

- Males must be surgically sterile or must use a condom in addition to highly
effective birth control if his partners are of reproductive potential from the time
of enrollment and for at least 4 months after last dose of DS-1062a or for at least
6 months after the last dose of docetaxel

- Male participants must not freeze or donate sperm from the time of Screening and
throughout the study period and for at least 4 months after the last dose of
DS-1062a or for at least 6 months after the last dose of docetaxel

- Female participants must not donate, or retrieve for their own use, ova from the
time of Screening and throughout the study period and for at least 7 months after
the last dose of DS-1062a and for at least 6 months after the last dose of docetaxel

Exclusion Criteria:

- Mixed small-cell lung cancer (SCLC) and NSCLC histology

- 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. Participants with clinically
inactive brain metastases may be included in the study. Participants with treated
(ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel;Overall Survival (OS) Following DS-1062a Versus Docetaxel (ICTRP)

Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel;Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel;Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel (ICTRP)

Registrierungsdatum
19.11.2020 (ICTRP)

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
AstraZeneca (ICTRP)

Weitere Kontakte
Global Clinical Leader, Daiichi Sankyo (ICTRP)

Sekundäre IDs
2020-004643-80, 2023-509865-19-00, DS1062-A-U301 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT04656652 (ICTRP)