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DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer
EU CTIS ID: 2023-509865-19-00
What this study is testing
To compare the efficacy of DS-1062a with that of docetaxel, as measured by PFS and OS, for subjects with NSCLC with or without actionable genomic alterations
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has the ability to provide written informed consent by signing and dating the ICF prior to the start of any study-specific qualification procedures
- Within 7 days before randomization, has adequate hepatic function as detailed in the study protocol
- Within 7 days before randomization, has adequate renal function, including mild or moderate renal function, as detailed in the study protocol
- Has left ventricular ejection fraction (LVEF) ≥50% by either ECHO or MUGA scan within 28 days before randomization
- Has adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × ULN
- Has an adequate treatment washout period before randomization, as defined in the study protocol
You likely can't join if
- Has mixed small-cell lung cancer and NSCLC histology
- Has significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage
- Clinically significant corneal disease
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections
- Has known human immunodeficiency virus (HIV) infection that is not well controlled
- Has an active or uncontrolled hepatitis B and/or hepatitis 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], anti-hepatitis B surface antibody [anti-HBs], anti-hepatitis B core antibody [anti-HBc], or hepatitis B virus [HBV] DNA), and/or hepatitis C infection (as per hepatitis C virus [HCV] RNA) within 28 days of randomization. See section 5.2 of protocol for details.
See the full eligibility criteria
Who can join
- Has the ability to provide written informed consent by signing and dating the ICF prior to the start of any study-specific qualification procedures
- Within 7 days before randomization, has adequate hepatic function as detailed in the study protocol
- Within 7 days before randomization, has adequate renal function, including mild or moderate renal function, as detailed in the study protocol
- Has left ventricular ejection fraction (LVEF) ≥50% by either ECHO or MUGA scan within 28 days before randomization
- Has adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × ULN
- Has an adequate treatment washout period before randomization, as defined in the study protocol
- Adults ≥18 years
- Has a life expectancy ≥3 months based on Investigator's opinion.
- Subjects must have documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC
- Subject must meet the following prior therapy requirements: Subjects without AGA must meet ONE of the following prior therapy requirements for advanced or metastatic NSCLC: a. Received platinum-based chemotherapy in combination with α-PD- 1/α-PD-L1 monoclonal antibody as the only prior line of therapy OR b. Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy Subjects with AGA must meet the following prior therapy requirements for advanced or metastatic NSCLC: a. Has been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved for the subject's genomic alteration at the time of screening; OR one or more of the agents specified in the protocol b. Has received platinum-based chemotherapy as the only prior line of cytotoxic therapy c. May have received up to one α-PD-1/α-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 subject 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 pretreatment 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.
- Has measurable disease based on local imaging assessment using RECIST v1.1
- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or1 at Screening
- Within 7 days before randomization, has adequate bone marrow function as detailed in the study protocol
What rules you out
- Has mixed small-cell lung cancer and NSCLC histology
- Has significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage
- Clinically significant corneal disease
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections
- Has known human immunodeficiency virus (HIV) infection that is not well controlled
- Has an active or uncontrolled hepatitis B and/or hepatitis 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], anti-hepatitis B surface antibody [anti-HBs], anti-hepatitis B core antibody [anti-HBc], or hepatitis B virus [HBV] DNA), and/or hepatitis C infection (as per hepatitis C virus [HCV] RNA) within 28 days of randomization. See section 5.2 of protocol for details.
- Has a history of malignancy, other than NSCLC except a) adequately resected non melanoma skin cancer, b) curatively treated in situ disease, or c) other solid tumors curatively treated, with no evidence of disease for ≥3 years.
- Concomitant medical condition that would increase the risk of toxicity in the opinion of the Investigator
- Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline
- 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
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Has spinal cord compression or clinically active central nervous system (CNS) 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
- Is pregnant or breastfeeding or planning to become pregnant
- Has leptomeningeal carcinomatosis or metastasis
- Had prior treatment with: a. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I b. TROP2-targeted therapy c. Docetaxel
- 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
- Has NSCLC disease that is eligible for definitive local therapy alone
- Uncontrolled or significant cardiac disease as described in detail in the protocol
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United Kingdom
- China
- Canada
- Hong Kong
- Switzerland
- Australia
- United States
- Korea, Republic of
- Mexico
- Taiwan
- Argentina
- Singapore
- Russian Federation
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United Kingdom; China; Canada; Hong Kong; Switzerland and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.