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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06312137




Registration number
NCT06312137
Ethics application status
Date submitted
8/03/2024
Date registered
15/03/2024

Titles & IDs
Public title
A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
Scientific title
A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
Secondary ID [1] 0 0
2023-508012-35
Secondary ID [2] 0 0
2870-019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 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: Other - Pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel

Experimental: Pembrolizumab + Sacituzumab tirumotecan - Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 20 doses (\~40 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (\~42 weeks).

Active comparator: Pembrolizumab - Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks).


Treatment: Other: Sacituzumab tirumotecan
Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 40 weeks

Treatment: Other: Pembrolizumab
Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks

Treatment: Drugs: Cisplatin
Cisplatin is administered as 75 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase

Treatment: Drugs: Pemetrexed
Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.

Treatment: Drugs: Gemcitabine
Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m2 or 1250 mg/m2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.

Treatment: Drugs: Carboplatin
Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m2 or 200 mg/m2 IV infusion q3w for up to 12 weeks as background treatment.
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
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to ~ 93 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to ~ 118 months
Secondary outcome [2] 0 0
Distant metastasis-free survival (DMFS) as assessed by investigator
Timepoint [2] 0 0
Up to ~ 118 months
Secondary outcome [3] 0 0
Disease-Free Survival (DFS) as assessed by investigator
Timepoint [3] 0 0
Up to ~ 118 months
Secondary outcome [4] 0 0
Lung Cancer Specific Survival (LCSS)
Timepoint [4] 0 0
Up to ~ 118 months
Secondary outcome [5] 0 0
Number of Participants Who Experience at least One Adverse Event (AE)
Timepoint [5] 0 0
Up to ~ 118 months
Secondary outcome [6] 0 0
Number of Participants Who Discontinue Study Intervention Due to AEs
Timepoint [6] 0 0
Up to ~ 118 months
Secondary outcome [7] 0 0
Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30)
Timepoint [7] 0 0
Baseline and up to ~118 months
Secondary outcome [8] 0 0
Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5)
Timepoint [8] 0 0
Baseline and up to ~118 months
Secondary outcome [9] 0 0
Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7)
Timepoint [9] 0 0
Baseline and up to ~118 months
Secondary outcome [10] 0 0
Change from Baseline in Dyspnea scores (QLQ-C30 Item 8)
Timepoint [10] 0 0
Baseline and up to ~118 months
Secondary outcome [11] 0 0
Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52)
Timepoint [11] 0 0
Baseline and up to ~118 months
Secondary outcome [12] 0 0
Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)
Timepoint [12] 0 0
Baseline and up to ~118 months

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



* Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]) per AJCC eighth edition guidelines.
* Has confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy.
* Is able to undergo surgery based on opinion of investigator after consultation with surgeon.
* Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy.
* Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
* Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period.
* Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization.
* Participants who have AEs due to previous anticancer therapies must have recovered to =Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening.
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has one of the following tumor locations/types:

* NSCLC involving the superior sulcus
* Large cell neuro-endocrine cancer (LCNEC)
* Sarcomatoid tumor
* Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
* Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
* 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 active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
* Has received prior neoadjuvant therapy for their current NSCLC diagnosis.
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.
* Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Has an active infection requiring systemic therapy.
* Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection.
* Has a severe hypersensitivity (Grade =3) to sacituzumab tirumotecan, any of its excipients and/or to another biologic therapy.
* Has a history of allogeneic tissue/solid organ transplant.
* Has not adequately recovered from major surgery or have ongoing surgical complications.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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
3/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/10/2034
Actual
Sample size
Target
780
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Westmead Hospital-Department of Medical Oncology ( Site 0701) - Westmead
Recruitment hospital [2] 0 0
The Prince Charles Hospital ( Site 0700) - Brisbane
Recruitment hospital [3] 0 0
Fiona Stanley Hospital-Medical Oncology ( Site 0705) - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Santa Fe
Country [13] 0 0
Argentina
State/province [13] 0 0
Cordoba
Country [14] 0 0
Austria
State/province [14] 0 0
Oberosterreich
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
Belgium
State/province [16] 0 0
Antwerpen
Country [17] 0 0
Belgium
State/province [17] 0 0
Namur
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio Grande Do Norte
Country [19] 0 0
Brazil
State/province [19] 0 0
Rio Grande Do Sul
Country [20] 0 0
Brazil
State/province [20] 0 0
Sao Paulo
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Chile
State/province [22] 0 0
Region M. De Santiago
Country [23] 0 0
Chile
State/province [23] 0 0
Valparaiso
Country [24] 0 0
China
State/province [24] 0 0
Beijing
Country [25] 0 0
China
State/province [25] 0 0
Fujian
Country [26] 0 0
China
State/province [26] 0 0
Guangdong
Country [27] 0 0
China
State/province [27] 0 0
Hubei
Country [28] 0 0
China
State/province [28] 0 0
Hunan
Country [29] 0 0
China
State/province [29] 0 0
Jiangsu
Country [30] 0 0
China
State/province [30] 0 0
Jiangxi
Country [31] 0 0
China
State/province [31] 0 0
Jilin
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Sichuan
Country [34] 0 0
China
State/province [34] 0 0
Yunnan
Country [35] 0 0
China
State/province [35] 0 0
Zhejiang
Country [36] 0 0
France
State/province [36] 0 0
Finistere
Country [37] 0 0
France
State/province [37] 0 0
Haute-Garonne
Country [38] 0 0
France
State/province [38] 0 0
Haute-Vienne
Country [39] 0 0
France
State/province [39] 0 0
Ile-de-France
Country [40] 0 0
France
State/province [40] 0 0
Nord
Country [41] 0 0
France
State/province [41] 0 0
Puy-de-Dome
Country [42] 0 0
France
State/province [42] 0 0
Rhone
Country [43] 0 0
France
State/province [43] 0 0
Var
Country [44] 0 0
France
State/province [44] 0 0
Paris
Country [45] 0 0
Germany
State/province [45] 0 0
Baden-Wurttemberg
Country [46] 0 0
Germany
State/province [46] 0 0
Rheinland-Pfalz
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Greece
State/province [48] 0 0
Achaia
Country [49] 0 0
Greece
State/province [49] 0 0
Attiki
Country [50] 0 0
Greece
State/province [50] 0 0
Irakleio
Country [51] 0 0
Greece
State/province [51] 0 0
Thessalia
Country [52] 0 0
Hong Kong
State/province [52] 0 0
Hksar
Country [53] 0 0
Hong Kong
State/province [53] 0 0
Yau Ma Tei
Country [54] 0 0
Israel
State/province [54] 0 0
Haifa
Country [55] 0 0
Israel
State/province [55] 0 0
Jerusalem
Country [56] 0 0
Israel
State/province [56] 0 0
Petah Tikva
Country [57] 0 0
Israel
State/province [57] 0 0
Ramat Gan
Country [58] 0 0
Italy
State/province [58] 0 0
Milano
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Chungbuk
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Kyonggi-do
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Taegu-Kwangyokshi
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Seoul
Country [63] 0 0
Mexico
State/province [63] 0 0
Jalisco
Country [64] 0 0
Netherlands
State/province [64] 0 0
Overijssel
Country [65] 0 0
Netherlands
State/province [65] 0 0
Utrecht
Country [66] 0 0
Netherlands
State/province [66] 0 0
Zuid-Holland
Country [67] 0 0
Norway
State/province [67] 0 0
Akershus
Country [68] 0 0
Norway
State/province [68] 0 0
Buskerud
Country [69] 0 0
Norway
State/province [69] 0 0
Oppland
Country [70] 0 0
Peru
State/province [70] 0 0
Lima
Country [71] 0 0
Poland
State/province [71] 0 0
Mazowieckie
Country [72] 0 0
Poland
State/province [72] 0 0
Podkarpackie
Country [73] 0 0
Poland
State/province [73] 0 0
Podlaskie
Country [74] 0 0
Poland
State/province [74] 0 0
Pomorskie
Country [75] 0 0
Portugal
State/province [75] 0 0
Porto
Country [76] 0 0
Romania
State/province [76] 0 0
Bucuresti
Country [77] 0 0
Romania
State/province [77] 0 0
Cluj
Country [78] 0 0
Romania
State/province [78] 0 0
Brasov
Country [79] 0 0
Spain
State/province [79] 0 0
Las Palmas
Country [80] 0 0
Spain
State/province [80] 0 0
Madrid
Country [81] 0 0
Spain
State/province [81] 0 0
Barcelona
Country [82] 0 0
Switzerland
State/province [82] 0 0
Grisons
Country [83] 0 0
Switzerland
State/province [83] 0 0
Thurgau
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taipei
Country [85] 0 0
Taiwan
State/province [85] 0 0
Taoyuan
Country [86] 0 0
Taiwan
State/province [86] 0 0
Kaohsiung
Country [87] 0 0
Taiwan
State/province [87] 0 0
Taichung
Country [88] 0 0
Taiwan
State/province [88] 0 0
Tainan
Country [89] 0 0
Turkey
State/province [89] 0 0
Ankara

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
Trialsites@msd.com
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/NCT06312137