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: 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
- EUCTR2021-003578-30-NL
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 520
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
4) Testing for EGFR, ALK, and PD-L1 is required. Testing for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment.
5) Must have progressed after platinum-based chemotherapy in combination with anti-PD-L1 antibody OR platinum-based chemotherapy and anti-PD-L1 antibody (in either order) sequentially.
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
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 aminotransferase = 2.5 ULN or = 5 ULN if known liver metastases, and serum albumin > 3 g/dL).
10) Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation
11) Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
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 338
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 182
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 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
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
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
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, 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%
13) Active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or gastrointestinal perforation within 6 months of enrollment
14) Active serious infection requiring antibiotics
15) Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism
16) 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
17) Positive he
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 OS of SG versus docetaxel.;Secondary Objective: To compare the effect of SG versus docetaxel on the<br>following:<br>-PFS as assessed by the investigator per Response Evaluation Criteria in Solid Tumors <br>-ORR as assessed by the investigator<br>-DOR as assessed by the investigator<br>-Disease control rate (DCR) as assessed by the investigator<br>-Safety and tolerability<br>-QOL using NSCLC Symptom Assessment Questionnaire;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Monitored throughout the study
- Secondary Outcome Measures
Name Time Method