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MK2870-007

Etude de phase 3 randomisée, en ouvert, évaluant le MK-2870 associé au pembrolizumab par rapport au pembrolizumab en monothérapie dans le traitement de première ligne chez des participants atteints d’un cancer bronchique non à petites cellules métastatique présentant un score de proportion tumorale (TPS) du PD-L1 supérieur ou égal à 50%

Critères d'inclusion :

1. Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c, AJCC Staging Manual, version 8)

 

Note: Mixed tumors will be characterized by the predominant cell type (squamous or

nonsquamous); however, small cell elements are not permitted

2. Confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R] AND absence of ALK and ROS1 gene rearrangements)

 

Note: If participant’s tumor has a predominantly squamous histology, molecular testing for EGFR mutation and ALK and ROS1 translocations is not required

 

Note: The presence of a KRAS mutation in a participant’s tumor is permitted

3. Has provided tumor tissue that demonstrates PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as assessed by IHC at a central laboratory

4. Is an individual of any sex/gender, who is at least 18 years of age at the time of providing the informed consent

5. If capable of producing sperm, the participant 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. After the last dose of study intervention, the length of time required to continue contraception for each study intervention is :

  • MK-2870: 100 days

  • Pembrolizumab: no contraception required for participants capable of producing sperm

6. A subject who is not pregnant and not breastfeeding

7. The participant (or legally acceptable representative) has provided documented informed consent for the study

8. Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.

Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions

9. Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion (not previously irradiated) obtained as part of clinical practice has been provided. Details pertaining to tumor tissue submission can be found in the Laboratory

Manual.

 

Note : Tumor tissue will be used to determine PD-L1 and TROP2 status by central testing

before randomization. Tumor tissue from after diagnosis of metastatic disease is preferred.

10. An ECOG performance status of 0 to 1 assessed within 7 days before randomization

11. HIV-infected participants must have well controlled HIV

12. Participants who are 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

13. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening

14. A life expectancy of at least 3 months

15. 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

16. Adequate organ function as defined in table below. Specimens must be collected within

10 days before the start of study intervention 

Critères de non inclusion :

1. Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements

2. Has Grade ≥2 peripheral neuropathy

3. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing

4. Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)

5. 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 QTcF interval to >480 ms,  nd/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention

6. Received prior systemic anticancer therapy for their metastatic NSCLC

 

Note: Prior treatment with chemotherapy and/or radiation as part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC

7. 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)

Note: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC

8. Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization

9. Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention

10. Requires treatment with a strong inhibitor or inducer of CYP3A4 at least 14 days before the first dose of study intervention and throughout the study

11. Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids

 

Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention

12. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed

13. Received prior treatment with a TROP2-targeted ADC

14. Received prior treatment with a topoisomerase I inhibitor-containing ADC

15. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration

16. 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

17. Known additional malignancy that is progressing or has required active treatment within

the past 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

 

Note : Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded

18. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention

19. Known intolerance to MK-2870 or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary

20. Known hypersensitivity to MK-2870 or other biologic therapy

21. Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed

22. History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.

 

Note : Participants with lymphangitic spread of their NSCLC are not excluded

23. Active infection requiring systemic therapy

24. 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

25. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease

26. 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

27. Known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study

28. History of allogeneic tissue/solid organ transplant

29. Participants who have not adequately recovered from major surgery or have ongoing surgical complications

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