C34 Malignant neoplasm of bronchus and lung Malignant neoplasm of bronchus and lung
Conditions
Interventions
Sacituzumab govitecan lyophilized powder, 10mg/kg by intravenous infusion every 3 weeks until progressive disease, death, unacceptable toxicity, or other criteria for treatment discontinuation are met
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 2. Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. 1. Has a histologically or cytologically confirmed diagnosis of NSCLC (Stage IV: M1a, M1b, M1c, AJCC Staging Manual, version 8). 3. Has confirmation that EGFR-, ALK-, or ROS-1-directed therapy is not indicated as primary therapy (documentation of the absence of tumor-activating EGFR mutations [eg, DEL19 or L858R], AND absence of ALK and ROS-1 gene rearrangements). 4. Has provided tumor tissue that demonstrates PD-L1 expression in =50% of tumor cells (TPS =50%) as assessed by IHC at a central laboratory. 5. Is male or female, =18 years of age at the time of providing informed consent. (Demographics) 6. Has a life expectancy of at least 3 months. (Demographics) 7. If male, agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: - sacituzumab govitecan: 95 days - pembrolizumab: no requirement • Refrains from donating sperm PLUS either: • Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR • Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview) as detailed below: - Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penilevaginal penetration. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed. (MALE PARTICIPANTS) 8. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: • Not a WOCBP OR • A WOCBP and: - Uses a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows: o sacituzumab govitecan: 180 days o pembrolizumab: 120 days The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the
Exclusion criteria
Exclusion criteria: 17. Has history of HIV infection. HIV testing is not required unless mandated by local health authority. (Diagnostic Assessments) 18. History of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as detectable HCV RNA [qualitative]) infection. Note: Testing for Hepatitis B or C is not required unless mandated by local health authority. (Diagnostic Assessments) 19. Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. (Diagnostic Assessments) Medical Conditions 1. Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. 2. Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for non-mNSCLC is allowed as long as therapy was completed at least 12 months before the diagnosis of mNSCLC. Note: Participants must have recovered from all AEs due to previous therapies to =Grade 1 or baseline. Participants with =Grade 2 neuropathy may be eligible. Participants with endocrine-related AEs Grade =2 requiring treatment or hormone replacement may be eligible. (Prior/Concomitant Therapy) 3. Has previously received treatment with any of the following: - Topoisomerase 1 inhibitors. Any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase 1. - Trop-2-targeted therapy. (Prior/Concomitant Therapy) 4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). Prior (neo)adjuvant therapy with PD-(L)1 agent is not allowed. (Prior/Concomitant Therapy) 5. Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout is permitted. (Prior/Concomitant Therapy) 6. Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention. (Prior/Concomitant Therapy) 7. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. Refer to Section 6.5 for information on COVID-19 vaccines (Prior/Concomitant Therapy) 8. Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration. (Prior/Concurrent Clinical Study Experience) 9. Cardiac disease - Myocardial infarction or unstable angina pectoris within 6 months of enrollment. - History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Imaging and Assessment of Disease according to RECIST 1.1. (Evaluation of scan changes in tumor burden over time,) NAME OF THE RESULT: Progression-free survival (Efficacy evaluation criterion) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At 6 weeks from the date of randomization, then at Week 12, Week 18 and Week 24. Subsequent tumor scans should be performed every 9 weeks or more frequently if clinically indicated. After 51 weeks, participants who remain on treatment will have scans performed every 12 weeks. End-of-Treatment and Follow-up Tumor Scans: -If participants discontinue study intervention, tumor scans should be performed at the time of discontinuation (±4 week window). -If participants discontinue study intervention due to documented disease progression, this is the final required tumor scan. -If participants discontinue study intervention without documented disease progression: Monitoring should continue using the same schedule calculated from the date of randomization.;Time elapsed NAME OF THE RESULT: Overall Survival (Efficacy evaluation criterion) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to death due to any cause.;For safety data analysis using the ApaT population, participants will be included in the Treatment group corresponding to the study treatment they actually received. AEs will be assessed according to the NCI CTCAE version 5.0 definition. NAME OF THE RESULT: The safety and tolerability of study treatment will be determined by clinical review of all relevant parameters, including AEs, laboratory tests, and vital signs. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 30 days after last dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor Imaging and Assessment of Disease according to RECIST 1.1. (Evaluation of scan changes in tumor burden over time,) NAME OF THE RESULT: Progression-free survival (Efficacy evaluation criterion) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At 6 weeks from the date of randomization, then at Week 12, Week 18 and Week 24. Subsequent tumor scans should be performed every 9 weeks or more frequently if clinically indicated. After 51 weeks, participants who remain on treatment will have scans performed every 12 weeks. End-of-Treatment and Follow-up Tumor Scans: -If participants discontinue study intervention, tumor scans should be performed at the time of discontinuation (±4 week window). -If participants discontinue study intervention due to documented disease progression, this is the final required tumor scan. -If participants discontinue study intervention without documented disease progression: Monitoring should continue using the same schedule calculated from the date of randomization.;Time elapsed NAME OF THE RESULT: Overall Survival (Efficacy evaluation criterion) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to death due to any cause.;Repeat scan performed NAME OF THE RESULT: Objective response (Efficacy evaluation criterion) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At least 4 weeks after the first indication of a response is observed. Participants will then return to the regular scan schedule, starting with the next scheduled time point.;Time elapsed NAME OF THE RESULT: Duration of Response (Efficacy evaluation criterion) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.;For safety data | — |
Countries
Austria, Brazil, Canada, Chile, China, Estonia, Germany, Greece, Israel, Italy, Japan, Korea South, Latvia, Lithuania, Mexico, Peru, Poland, Romania, South Africa, Taiwan, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactNELVA GARCIA
MERCK SHARP & DOHME PERU S.R.L.
Outcome results
None listed