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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06074588




Registration number
NCT06074588
Ethics application status
Date submitted
3/10/2023
Date registered
10/10/2023

Titles & IDs
Public title
Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
Scientific title
A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations
Secondary ID [1] 0 0
2023-503539-16
Secondary ID [2] 0 0
2870-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Sacituzumab tirumotecan
Treatment: Drugs - Docetaxel
Treatment: Drugs - Pemetrexed

Experimental: Sacituzumab tirumotecan - Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.

Active comparator: Chemotherapy - Participants will receive 75 mg/m\^2 of docetaxel or 500 mg/m\^2 of pemetrexed by IV infusion on Days 1 and 22 of every 6-week cycle.


Treatment: Other: Sacituzumab tirumotecan
4 mg/kg of MK-sacituzumab tirumotecan by IV infusion

Treatment: Drugs: Docetaxel
75 mg/m\^2 of docetaxel by IV Infusion

Treatment: Drugs: Pemetrexed
500 mg/m\^2 of pemetrexed by IV infusion
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations
Timepoint [1] 0 0
Up to approximately 35 months
Primary outcome [2] 0 0
Overall Survival (OS) of Participants with NSCLC with EGFR mutations
Timepoint [2] 0 0
Up to approximately 41 months
Secondary outcome [1] 0 0
PFS of All Participants with NSCLC
Timepoint [1] 0 0
Up to approximately 35 months
Secondary outcome [2] 0 0
OS of All Participants with NSCLC
Timepoint [2] 0 0
Up to approximately 41 months
Secondary outcome [3] 0 0
Objective Response Rate (ORR) of Participants with NSCLC with EGFR Mutations
Timepoint [3] 0 0
Up to approximately 35 months
Secondary outcome [4] 0 0
ORR of All Participants with NSCLC
Timepoint [4] 0 0
Up to approximately 35 months
Secondary outcome [5] 0 0
Duration of Response (DOR) of All Participants with NSCLC
Timepoint [5] 0 0
Up to approximately 6 years
Secondary outcome [6] 0 0
Change in Score from Baseline in Global Health Status/QoL Score (European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] Items 29 and 30)
Timepoint [6] 0 0
Baseline and up to approximately 48 weeks
Secondary outcome [7] 0 0
Change in Score from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
Timepoint [7] 0 0
Baseline and up to approximately 48 weeks
Secondary outcome [8] 0 0
Change in Score from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 [QLQ-LC13] Item 31)
Timepoint [8] 0 0
Baseline and up to approximately 48 weeks
Secondary outcome [9] 0 0
Change in Score from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40)
Timepoint [9] 0 0
Baseline and up to approximately 48 weeks
Secondary outcome [10] 0 0
Time to Deterioration (TTD) from Baseline in Global Health Status/QoL Score (EORTC QLQ-C30 Items 29 and 30)
Timepoint [10] 0 0
Up to approximately 48 weeks
Secondary outcome [11] 0 0
TTD from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
Timepoint [11] 0 0
Up to approximately 48 weeks
Secondary outcome [12] 0 0
TTD from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 [QLQ-LC13] Item 31)
Timepoint [12] 0 0
Up to approximately 48 weeks
Secondary outcome [13] 0 0
Time to Deterioration from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40)
Timepoint [13] 0 0
Up to approximately 48 weeks
Secondary outcome [14] 0 0
Number of Participants Who Experience One or More Adverse Events (AEs)
Timepoint [14] 0 0
Up to approximately 6 years
Secondary outcome [15] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timepoint [15] 0 0
Up to approximately 4 years

Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:



* Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
* Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
* Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
* Measurable disease per RECIST 1.1 as assessed by the local site investigator.
* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
* Participants who have AEs due to previous anticancer therapies must have recovered to Grade =1 or baseline.
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
* Have an ECOG performance status of 0 or 1 within 3 days before randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has predominantly squamous cell histology NSCLC.
* Has mixed tumor(s) with small cell elements.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
* Has Grade =2 peripheral neuropathy.
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
* Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
* Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
* Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
* Received prior treatment with a topoisomerase I-containing ADC.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Active infection requiring systemic therapy.
* History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
* Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/03/2030
Actual
Sample size
Target
556
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St. George Private Hospital ( Site 3004) - Kogarah
Recruitment hospital [2] 0 0
Westmead Hospital-Department of Medical Oncology ( Site 3000) - Westmead
Recruitment hospital [3] 0 0
Monash Health-Oncology Research ( Site 3001) - Clayton
Recruitment hospital [4] 0 0
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003) - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3021 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Mississippi
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio Grande Do Norte
Country [8] 0 0
Brazil
State/province [8] 0 0
Rio Grande Do Sul
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Chile
State/province [11] 0 0
Araucania
Country [12] 0 0
Chile
State/province [12] 0 0
Maule
Country [13] 0 0
Chile
State/province [13] 0 0
Region M. De Santiago
Country [14] 0 0
Chile
State/province [14] 0 0
Valparaiso
Country [15] 0 0
China
State/province [15] 0 0
Beijing
Country [16] 0 0
China
State/province [16] 0 0
Chongqing
Country [17] 0 0
China
State/province [17] 0 0
Fujian
Country [18] 0 0
China
State/province [18] 0 0
Guangdong
Country [19] 0 0
China
State/province [19] 0 0
Guangxi
Country [20] 0 0
China
State/province [20] 0 0
Heilongjiang
Country [21] 0 0
China
State/province [21] 0 0
Henan
Country [22] 0 0
China
State/province [22] 0 0
Hubei
Country [23] 0 0
China
State/province [23] 0 0
Hunan
Country [24] 0 0
China
State/province [24] 0 0
Jiangsu
Country [25] 0 0
China
State/province [25] 0 0
Jiangxi
Country [26] 0 0
China
State/province [26] 0 0
Shaanxi
Country [27] 0 0
China
State/province [27] 0 0
Shandong
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Sichuan
Country [30] 0 0
China
State/province [30] 0 0
Yunnan
Country [31] 0 0
China
State/province [31] 0 0
Zhejiang
Country [32] 0 0
Hong Kong
State/province [32] 0 0
Central
Country [33] 0 0
Hong Kong
State/province [33] 0 0
Hksar
Country [34] 0 0
Hong Kong
State/province [34] 0 0
Kowloon
Country [35] 0 0
Hong Kong
State/province [35] 0 0
Lai Chi Kok
Country [36] 0 0
Israel
State/province [36] 0 0
Haifa
Country [37] 0 0
Israel
State/province [37] 0 0
Jerusalem
Country [38] 0 0
Israel
State/province [38] 0 0
Petah Tikva
Country [39] 0 0
Japan
State/province [39] 0 0
Aichi
Country [40] 0 0
Japan
State/province [40] 0 0
Hyogo
Country [41] 0 0
Japan
State/province [41] 0 0
Kanagawa
Country [42] 0 0
Japan
State/province [42] 0 0
Miyagi
Country [43] 0 0
Japan
State/province [43] 0 0
Osaka
Country [44] 0 0
Japan
State/province [44] 0 0
Tokyo
Country [45] 0 0
Japan
State/province [45] 0 0
Fukuoka
Country [46] 0 0
Japan
State/province [46] 0 0
Okayama
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Chungbuk
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Jeonranamdo
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Kyonggi-do
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Kyongsangnam-do
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Pusan-Kwangyokshi
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Taejon-Kwangyokshi
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul
Country [54] 0 0
Malaysia
State/province [54] 0 0
Kelantan
Country [55] 0 0
Malaysia
State/province [55] 0 0
Kuala Lumpur
Country [56] 0 0
Malaysia
State/province [56] 0 0
Sarawak
Country [57] 0 0
Thailand
State/province [57] 0 0
Krung Thep Maha Nakhon
Country [58] 0 0
Thailand
State/province [58] 0 0
Chiang Mai
Country [59] 0 0
Thailand
State/province [59] 0 0
Khon Kaen
Country [60] 0 0
Turkey
State/province [60] 0 0
Ankara
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Kensington And Chelsea
Country [62] 0 0
United Kingdom
State/province [62] 0 0
London, City Of
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Sutton
Country [64] 0 0
Vietnam
State/province [64] 0 0
Ha Noi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06074588