Phase 2 Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer with Actionable Genomic Alterations

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 150

Inclusion Criteria

13. Has a left ventricular ejection fraction (LVEF) =50% by either an
ECHO or MUGA scan within 28 days before Cycle 1 Day 1.
14. Has adequate blood clotting function defined as international
normalized ratio/prothrombin time and either partial thromboplastin or
activated partial thromboplastin =1.5 × ULN.
15. Has an adequate treatment washout period before Cycle 1 Day 1
defined as:
-Major surgery: =3 weeks
-Radiation therapy including palliative radiation to chest =4 weeks
(palliative radiation therapy to other areas: =2 weeks)
-Anti-cancer chemotherapy (immunotherapy [non-antibody-based
therapy]), retinoid therapy: =2 weeks or 5 times the t1/2 of the
chemotherapeutic agent, whichever is longer; =6 weeks for nitrosoureas
or mitomycin C, =1 week for TKIs approved for the treatment of NSCLC -
baseline CT scan must be completed after discontinuation of TKI
-Antibody-based anti-cancer therapy: =4 weeks
-Chloroquine/Hydroxychloroquine: >14 days
16. Has a life expectancy =3 months based on investigator's opinion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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. Subjects with clinically inactive brain metastases may be
included in the study. Subjects with treated brain metastases that are no
longer symptomatic and who require no treatment with corticosteroids
or anticonvulsants may be included in the study if they have recovered
from the acute toxic effect of radiotherapy. A minimum of 2 weeks must
have elapsed between the end of whole brain radiotherapy and study
enrollment.
Note: A CT or magnetic resonance imaging (MRI) scan of the brain at
baseline is required for all subjects. For those subjects in whom CNS
metastases are first discovered at the time of screening, the treating
investigator should consider delay of study treatment to document
stability of CNS metastases with repeat imaging at least 4 weeks later
(in which case, repeat of all screening activity may be required).
2. Has leptomeningeal carcinomatosis.
3. Prior treatment with:
a. An ADC containing a chemotherapeutic agent targeting topoisomerase I.
b. TROP2-targeted therapy.
4. Uncontrolled or significant cardiovascular disease, including:
a. Mean QT interval corrected for heart rate using Fridericia's formula
(QTcF) >470 milliseconds (msec) for females or >450 msec for males
(based on the average of screening triplicate 12-lead ECG
determinations).
b. History of myocardial infarction within 6 months prior to C1D1
c. History of uncontrolled angina pectoris within 6 months prior to C1D1
d. Symptomatic congestive heart failure (CHF) (New York Heart
Association Class II to IV) at screening. Subjects with a history of Class
II to IV CHF prior to screening, must have returned to class I CHF and
have LVEF =50% (by either an ECHO or MUGA scan within 28 days of
Cycle 1 Day 1) in order to be eligible.
e. History of serious cardiac arrhythmia requiring treatment.
f. LVEF <50% or institutional lower limit of normal by ECHO or MUGA
scan. within 28 days before Cycle 1 Day 1.
g. Uncontrolled hypertension (systolic >180
mmHg or diastolic >110 mmHg) within 28 days before C1D1
5. Has a history of (non-infectious) ILD/pneumonitis that required
steroids, has current ILD/pneumonitis, or where suspected
ILD/pneumonitis cannot be ruled out by imaging at screening.
6. Clinically severe pulmonary compromise resulting from intercurrent
pulmonary illnesses including, but not limited to, any underlying
pulmonary disorder (ie, pulmonary emboli within 3 months of the study
C1D1, severe asthma, severe chronic obstructive pulmonary
disease [COPD], restrictive lung disease, pleural effusion, etc.), or any
autoimmune, connective tissue or inflammatory disorders with
pulmonary involvement (ie, rheumatoid arthritis, Sjögren's syndrome,
sarcoidosis, etc.), or prior pneumonectomy.
7. Clinically significant corneal disease.
8. Uncontrolled infection requiring IV antibiotics, antivirals, or
antifungals. Note: Subjects with localized fungal infections of skin or
nails are eligible.
9. Has known HIV infection that is not well controlled. All of the
following criteria are required to define an HIV infection that is well
controlled: undetectable viral RNA load, CD4+ counts/levels >250, no
history of AIDs-defining opportunistic infection within the past 12
months, and stable for at least 4 weeks on same anti-HIV retroviral
medications. If an HIV infection m

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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