Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

JRCT ID: jRCT2051220119

Registered date:21/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 12/01/2023
• Target sample size: 580
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,France,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Puerto Rico,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan,Portugal,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Sacituzumab govitecan 10mg/kg via IV infusion on Days1 and 8 of a 21day cycle
Other Names: IMMU-132, GS-0132

Drug: Docetaxel
Administered intravenously
Docetaxel 75mg/m^2 via IV infusion on Day1 of a 21day cycle

Outcome(s)

Primary Outcome

Overall Survival (OS) [ Time Frame: Up to 30 months ]
OS is defined as the time from the date of randomization until the date of death from any cause.

Secondary Outcome

Progression-free Survival (PFS) Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 30 months ] PFS is defined as the time from the date of randomization until the date of objective disease progression (PD) or death from any cause, whichever occurs first.

Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1 [ Time Frame: Up to 30 months ] ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.

Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1 [ Time Frame: Up to 30 months ] DOR is defined as time from first documented CR or PR to the earlier of the first documented PD or death from any cause (whichever comes first)

Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1 [ Time Frame: Up to 30 months ] DCR is defined as the proportion of participants who achieve a CR, PR, or stable disease (SD) as assessed by RECIST Version 1.1.

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 30 months plus 30 days ]

Percentage of Participants Experiencing Laboratory abnormalities [ Time Frame: First dose date up to 30 months plus 30 days ]

Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Score [ Time Frame: Up to 30 Months ]
- The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The dyspnea (shortness of breath) item uses a "Never to Always" rating scale with higher score indicating higher frequency of dyspnea.

Time to First Deterioration in NSCLC-SAQ Total Score [ Time Frame: Up to 30 Months ]
- The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The sum of all 5 domain scores will be computed, if any scores are missing, a total score will not be computed. The total score ranges between 0 and 20 with higher scores indicating more severe symptoms.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).

Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein1 (PD-1)/programmed death ligand1 (PD-L1) results are required. Testing prior to enrollment. 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.
- No additional treatments are allowed in the recurrent/metastatic setting for individuals with no actionable genomic alterations.
- Individuals with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 approved tyrosine kinase inhibitor 1(TKI) appropriate to the genomic alteration.
- 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.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin >= 9 g/dL, absolute neutrophil count >= 1500/mm^3, and platelets >= 100,000/uL).

Adequate hepatic function (bilirubin <= 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase <= 2.5 ULN or <= 5 x ULN if known liver metastases, and serum albumin > 3 g/dL).

Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation.

Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Exclude criteria

Mixed small-cell lung cancer and NSCLC histology.

Positive serum pregnancy test or women who are lactating.

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 adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.

Have not recovered (ie, > Grade 2 is considered not recovered) from AEs due to a previously administered agent.

Previously received treatment with any of the following:
- Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase 1
- Trop-2-targeted therapy
- Docetaxel as monotherapy or in combination with other agents

Active second malignancy

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.

Active cardiac disease

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. Individuals 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Information

• Primary Sponsor: Iwahori Yuki
• Secondary ID(s): NCT05089734,2021-003578-30