DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer Without Genomic Alterations
- Conditions
- Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-004643-80-FR
- Lead Sponsor
- Daiichi Sankyo, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 590
1. Has the ability to provide written informed consent by signing and dating the ICF prior to the start of any study-specific qualification procedures
2. Adults =18 years
3. Has a life expectancy =3 months based on Investigator’s opinion and has pathologically documented NSCLC (please see further details in the protocol)
5. Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC
6. Subject must meet ONE of the following prior therapy requirements for advanced or metastatic NSCLC:
a. Received platinum-based chemotherapy in combination with a-PD-1/a-PD-L1 monoclonal antibody as the only prior line of therapy
OR
b. 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
7. Willing and able to undergo a mandatory pre-treatment tumor biopsy
8. Archival tumor tissue from initial diagnosis is required, to the extent that archival tumor tissue is available
9. Has measurable disease based on local imaging assessment using RECIST v1.1
10. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or1 at Screening
11. Within 7 days before Cycle 1 Day 1, has adequate bone marrow function as detailed in the study protocol
12. Within 7 days before Cycle 1 Day 1, has adequate hepatic function as detailed in the study protocol
13. Within 7 days before Cycle 1 Day 1, has adequate renal function, including mild or moderate renal function, as detailed in the study protocol
14. Has left ventricular ejection fraction (LVEF) =50% by either ECHO or MUGA scan within 28 days before Cycle 1 Day 1
15. Has adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time =1.5 × ULN
16. Has an adequate treatment washout period before Cycle 1 Day 1, as defined in the study protocol
For the full list of inclusion criteria, please see protocol section 5.1
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 443
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 147
1. Has mixed small-cell lung cancer and NSCLC histology
2. 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. Please see additional details in the protocol
3. Has leptomeningeal carcinomatosis or metastasis
4. Had prior treatment with:
a. Any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase I
b. TROP2-targeted therapy
c. Docetaxel as monotherapy or in combination with other agents
5. Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting the prior therapy requirements for Stage III or metastatic NSCLC disease as described in Inclusion Criterion 6
6. Has NSCLC disease that is eligible for definitive local therapy alone
7. Uncontrolled or significant cardiovascular disease as described in detail in the protocol
8. 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
9. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement, or prior pneumonectomy
10. Has significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage
11. Clinically significant corneal disease
12. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections
13. Has known human immunodeficiency virus (HIV) infection that is not well controlled
14. Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1
15. Has other primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for =3 years
16. Concomitant medical condition that would increase the risk of toxicity in the opinion of the Investigator
17. Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade =1 or baseline
18. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients (including but not limited to polysorbate 80) of DS-1062a or docetaxel
19. History of severe hypersensitivity reactions to other monoclonal antibodies
20. Is pregnant or breastfeeding or planning to become pregnant
For the full list of exclusion criteria, please see protocol section 5.2.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of DS-1062a with that of docetaxel, as measured by PFS and OS, for subjects with NSCLC without actionable genomic alterations previously treated with platinum-based chemotherapy and an a-PD- 1/a-PD-L1 monoclonal antibody;Secondary Objective: - To further evaluate the efficacy of DS-1062a compared with docetaxel<br>- To further evaluate the safety of DS-1062a compared with docetaxel<br>- To assess the PK of DS-1062a<br>- To assess the immunogenicity of DS-1062a;Primary end point(s): - PFS: defined as the time from randomization to the earlier of the dates of the first radiographic disease progression or death due to any<br>cause.<br>- OS: defined as the time from randomization to death due to any cause.;Timepoint(s) of evaluation of this end point: At the pre-determined timepoints as described in the protocol.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - ORR<br>- DoR<br>- TTR<br>- DCR<br>- EORTC-QLQC30 and EORTC-QLQLC13 (except questions 36 and 37)<br>- TEAEs and other safety parameters during the study<br>- PK<br>- Immunogenicity;Timepoint(s) of evaluation of this end point: At the pre-determined timepoints as described in the protocol.