A study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).
- Conditions
- on-small cell lung cancerMedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-512148-50-00
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 542
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):, Adequate hepatic function (bilirubin = 1.5 upper limit of normal [ULN], aspartate aminotransferase and alanine aminotransferase = 2.5 ? ULN or = 5 ? ULN if known liver metastases, and serum albumin > 3 g/dL). • Note: The investigator should follow local practice guidelines and/or the docetaxel label approved in the country of drug administration for assessing eligibility of patients for the study., Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation {Cockcroft 1976}., Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 3., Female or male patients, 18 years of age or older, able to understand and give written informed consent, Life expectancy of 3 months or more, 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)., 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., 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-PD-1/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., 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 d
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): Mixed small-cell lung cancer and NSCLC histology., 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., 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., 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, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation. c) New York Heart Association Class III or greater congestive heart failure or left ventricular ejection fraction of less than 40%, Active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or gastrointestinal perforation within 6 months of enrollment, Active serious infection requiring antibiotics., Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism., Positive for hepatitis B surface antigen. Patients who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease., Positive hepatitis C antibody and detectable hepatitis C viral load., Other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations., Positive serum pregnancy test (Appendix 3) or women who are lactating., Known hypersensitivity to the study drugs, their metabolites, or formulation excipients., 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., 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, 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 c
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