Advanced or metastatic non-small cell lung cancer Lung cancer
Conditions
Interventions
Please refer to table 1 of the Main ICF.
Sponsors
Gilead Sciences
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria at screening/Day *1 to be eligible for participation in this study (no waivers for patient eligibility will be offered or permitted): 1) Female or male patients, 18 years of age or older, able to understand and give written informed consent 2) Life expectancy of 3 months or more 3) Pathologically documented NSCLC with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition). 4) EGFR, ALK, and PD-L1 results are required prior to enrollment (see Section 6.3.10). Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For patients with squamous cell carcinoma, EGFR and ALK testing is optional. 5) Must have progressed after platinum-based chemotherapy in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially. • Note: Includes patients who received prior platinum based chemoradiotherapy (with or without maintenance anti PD1/PD L1 antibody) for Stage 3 disease. To be considered to have progressed during or after prior treatment with platinum-based chemotherapy, patients should have either received prior platinum-based chemotherapy in the recurrent/metastatic setting or have experienced disease progression within 6 months of last dose of platinum-based chemotherapy administered as part of concurrent chemoradiation for Stage 3 disease or as neoadjuvant or adjuvant therapy. To be considered to have progressed during or after prior treatment with an anti-PD-1/PD-L1 antibody, patients should have either received this therapy in the recurrent/metastatic setting or have experienced disease progression during *maintenance* treatment following concurrent chemoradiation for Stage 3 disease. a) No additional treatments are allowed in the recurrent/metastatic setting for patients with no actionable genomic alterations. b) Patients with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 locally approved and available TKI appropriate to the genomic alteration (see Appendix 8). c) Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC. 6) Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in accordance with per RECIST Version 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Historical images within 28 days of the screening visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator. 7) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix 5) before randomization. 8) Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin >= 9 g/dL, absolute neutrophil count >= 1500/mm3, and platelets >= 100,000/µL). 9) Adequate hepatic function (bilirubin <= 1.5 upper limit of normal [ULN], aspartate aminotransferase and alanine aminotransferas
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria at screening/Day *1 are not eligible to be enrolled in this study (no waivers for patient eligibility will be offered or permitted): 1) Mixed small-cell lung cancer and NSCLC histology. 2) Positive serum pregnancy test (Appendix 3) or women who are lactating. 3) Known hypersensitivity to the study drugs, their metabolites, or formulation excipients. 4) Requirement for ongoing therapy with or prior use of any prohibited medications for SG and docetaxel as per Sections 5.6.1 and 5.11, respectively. 5) Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, > Grade 2 is considered not recovered) from AEs at the time of study entry. Patients participating in observational studies are eligible. 6) Have not recovered (ie, > Grade 2 is considered not recovered) from AEs due to a previously administered agent. • Note: Patients with any grade alopecia are an exception to this criterion and will qualify for the study. • Note: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study drug. 7) Previously received treatment with any of the following: a) Topoisomerase 1 inhibitors. Any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase 1 b) Trop-2-targeted therapy c) Docetaxel as monotherapy or in combination with other agents 8) Active second malignancy • Note: Patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll. 9) NSCLC that is eligible for definitive local therapy alone. 10) 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 enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy. 11) Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking 10 mg/day or less of prednisone or its equivalent. All patients with carcinomatous meningitis are excluded regardless of clinical stability. 12) Met any of the following criteria for cardiac disease: a) Myocardial infarction or unstable angina pectoris within 6 months of enrollment. b) History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high grade atrioventricular block,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective • To compare the overall survival (OS) of sacituzumab govitecan (SG) versus docetaxel. Primary End Point • OS is defined as the time from the date of randomization until death due to any cause in the Intent-to-Treat (ITT) Analysis Set. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives To compare the effect of SG versus docetaxel on the following: • Progression-free survival (PFS) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. • Objective response rate (ORR) as assessed by the investigator per RECIST Version 1.1. • Duration of response (DOR) as assessed by the investigator per RECIST Version 1.1. • Disease control rate (DCR) as assessed by the investigator per RECIST Version 1.1. • Safety and tolerability. • Quality of life (QOL) using non-small cell lung cancer (NSCLC) Symptom Assessment Questionnaire (NSCLC-SAQ). Secondary End Points • PFS is defined as the time from the date of randomization until the date of objective disease progression or death (whichever comes first) as assessed by the investigator per RECIST Version 1.1. • ORR is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by the investigator per RECIST Version 1.1. • DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of progressive disease (PD) or death from any cause (whichever comes first) as assessed by the investigator per RECIST Version 1.1. • DCR is defined as the proportion of patients who achieve a CR, PR, or stable disease (SD) as assessed by the investigator per RECIST Version 1.1. • Incidence of treatment-emergent adverse events (TEAEs) and clinical laboratory abnormalities. • Time to first deterioration in shortness of breath domain as measured by NSCLC- SAQ. • Time to first deterioration in NSCLC-SAQ total score. Exploratory Objectives • To characterize the pharmacokinetics (PK) and immunogenicity of SG. • To assess disease-related symptoms and health related QOL using EQ 5D 3 level (EQ 5D 3L); NSCLC SAQ; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core | — |
Countries
Netherlands
Outcome results
None listed