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A study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).
EU CTIS ID: 2024-512148-50-00
What this study is testing
To compare the OS of SG versus docetaxel.
- 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
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix 11.6) before randomization
- 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).
- Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation {Cockcroft 1976}.
- Participants assigned male at birth and participants assigned female patientsat birth of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 11.4.
- Participants assigned female at birth or participants assigned male at birth 18 years of age or older, able to understand and give written informed consent
You likely can't join if
- 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.
- 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 11.4) or participants assigned female at birth 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 5.7.1 and 5.12, 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.Participants participating in observational studies are eligible.
See the full eligibility criteria
Who can join
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix 11.6) before randomization
- 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).
- Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation {Cockcroft 1976}.
- Participants assigned male at birth and participants assigned female patientsat birth of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 11.4.
- Participants assigned female at birth or participants assigned male at birth 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 participants 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 deemed acceptable in the opinion of the investigator.
What rules you out
- 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.
- 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 11.4) or participants assigned female at birth 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 5.7.1 and 5.12, 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.Participants participating in observational studies are eligible.
- 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
- NSCLC that is eligible for definitive local therapy alone.
- 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. Participants 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 participants 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. Participants 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- Brazil
- Mexico
- Australia
- Japan
- Israel
- Puerto Rico
- United States
- Turkey
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 United Kingdom; Canada; Brazil; Mexico; Australia; Japan and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.