Pembrolizumab With or Without MK-2870 in Resectable NSCLC not Achieving pCR

Phase 3

• Conditions: D022 Bronchus and lung; Bronchus and lung; D022

• Registration Number: PER-006-24
• Lead Sponsor: Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Without startig enrollment
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Type of Participant and Disease Characteristics.
Criteria 1 through 5 apply to screening for the neoadjuvant and adjuvant periods:
Criteria 1. Has histological confirmation of squamous or nonsquamous NSCLC, resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]) per AJCC eighth edition guidelines (Appendix 8). No restaging is required at the time of randomization.
Note: Lymph node disease requires histological confirmation if it will affect stage grouping stratification, otherwise imaging can act as a surrogate for pathological staging.

Type of Participant and Disease Characteristics. Criteria 1 through 5 apply to screening for the neoadjuvant and adjuvant periods:
Criteria 2. Confirmation that EGFR-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R]).
Note: If participant’s tumor has a predominantly squamous histology, molecular testing for EGFR mutation is not required.

Type of Participant and Disease Characteristics. Criteria 1 through 5 apply to screening for the neoadjuvant and adjuvant periods:
Criteria 3. Able to undergo surgery based on opinion of investigator after consultation with surgeon.

Type of Participant and Disease Characteristics. Criteria 1 through 5 apply to screening for the neoadjuvant and adjuvant periods:
Criteria 4. Able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy.
Note: Participants with resectable NSCLC (Criterion 1) previously treated outside the study with neoadjuvant pembrolizumab and platinum-based chemotherapy and successfully completed surgery with surgical tumor tissue sample available, may advance to screening for the pre-randomization period (see Section 1.3.3).

Type of Participant and Disease Characteristics. Criteria 1 through 5 apply to screening for the neoadjuvant and adjuvant periods:
Criteria 5. An ECOG performance status of 0 to 1 assessed within 10 days before first dose of study treatment.

Type of Participant and Disease Characteristics. Criteria 6 through 11 apply to screening for the adjuvant period only, before randomization:
Criteria 6. Achieved R0 or R1 resection status (see Section 8.1.8.3 for definitions).

Type of Participant and Disease Characteristics. Criteria 6 through 11 apply to screening for the adjuvant period only, before randomization:
Criteria 7. Has not achieved pCR at surgery by local review of pathology. See Section 4.1 for definition of pCR.

Type of Participant and Disease Characteristics. Criteria 6 through 11 apply to screening for the adjuvant period only, before randomization:
Criteria 8. Tumor tissue sample from surgical resection has been provided for determination of
PD-L1 and TROP2 status by central vendor before randomization into the

Exclusion Criteria

Prior/Concomitant Therapy: Exclusion Criteria #6, 10, and 11 do not apply to participants entering screening during the adjuvant period after receiving neoadjuvant therapy and surgery outside the study.
Criteria 11. Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.

Prior/Concomitant Therapy: Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.

Prior/Concomitant Therapy: Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Refer to Section 6.5 for information on COVID-19 vaccines.

Medical conditions:
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 ALK gene rearrangements (ALK status not required and unknown or undetermined ALK status are acceptable, central testing will not be provided)

Medical conditions: Has Grade =2 peripheral neuropathy.

Medical conditions: Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.

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

Medical conditions: 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, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of images according to RECIST 1.1 principle or biopsy; both evaluated by the BICR (Blinded Independent Central Review).<br> NAME OF THE RESULT: Efficacy endpoint:<br>BICR disease-free survival (DFS)<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Time from randomization to any recurrence (local, locoregional, regional, or distant) as assessed by blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST 1.1), the occurrence of a new primary NSCLC or death from any cause, whichever comes first.