Non-small Cell Lung Cancer
Conditions
Interventions
Arm A: Participants in the Dato-DXd arm will receive Dato-DXd monotherapy group as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Arm B: Participants in the docetaxel mo
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC: - Participants must have documented negative test results for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS proto-oncogene 1 (ROS1) genomic alterations. - Has no known tumour genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition (MET) exon 14 skipping, Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C, human epidermal growth factor receptor 2 (HER2) or any other actionable driver oncogenes for which there are locally approved and available targeted first-line therapies. - Prospectively assessed trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive. 2. Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC. 3. Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)/anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1/anti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy. 4. Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2. 5. At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as equal to or greater than 10 mm in the longest diameter (except lymph nodes, which must have short axis equal to or greater than 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. 7. Adequate bone marrow reserve and organ function within 7 days before randomisation.
Exclusion criteria
Exclusion criteria: 1. Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology. 2. NSCLC disease that is eligible for definitive local therapy alone. 3. History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence. 4. Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation. 5. Clinically significant corneal disease. 6. Has active or uncontrolled hepatitis B or C virus infection. 7. Known human immunodeficiency virus (HIV) infection that is not well controlled. 8. Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals. 9. History of non-infectious interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. 10. Severe pulmonary function compromise per Investigator discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS): PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR), or death due to any cause. Overall survival (OS): OS is defined as the time from randomization until the date of death due to any cause. | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Poland, South Korea, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Vietnam
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed