NCT06305754|RecruitingPhase 3DMCFDA Drug

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors

Merck Sharp & Dohme LLC ClinicalTrials.gov

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5 other identifiers

2870-0092023-504910-31-00U1111-1288-3804MK-2870-009jRCT2071240041

Study Type

interventional

Target

520

Locations

19 countries

Sites

156

Timeline

RegisteredMar 2024

StartedJun 2024

CompletionJun 2030

Brief Summary

The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

520

participants targeted

Target at P75+ for phase_3

Timeline

50mo left

Started Jun 2024

Longer than P75 for phase_3

Geographic Reach

19 countries

156 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 years study duration

Study Progress31%

Jun 2024Jun 2030

First Submitted

Initial submission to the registry

March 5, 2024

Completed

7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed

3 months until next milestone

Study Start

First participant enrolled

June 11, 2024

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2028

Expected

1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2030

Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

March 5, 2024

Last Update Submit

April 1, 2026

Conditions

Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (2)

Progression-Free Survival (PFS)
Progression-Free Survival is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PFS for all randomized participants will be reported.
Up to approximately 51 months
Overall Survival (OS)
Overall survival is defined as the time from randomization to death due to any cause. Overall survival for all randomized participants will be reported.
Up to approximately 51 months

Secondary Outcomes (12)

Objective Response Rate (ORR)
Up to approximately 51 months
Duration of Response (DOR)
Up to approximately 51 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Baseline and up to approximately 6 years
Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30
Baseline and up to approximately 6 years
Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13)
Baseline and up to approximately 6 years
+7 more secondary outcomes

Study Arms (2)

Sacituzumab tirumotecan

EXPERIMENTAL

Participants receive 4 mg/kg sacituzumab tirumotecan via intravenous (IV) infusion every 2 weeks (Days 1, 15, and 29 of every 6-week cycle) until discontinuation criteria is met.

Biological: Sacituzumab tirumotecanDrug: H1 Receptor AntagonistDrug: H2 Receptor AntagonistDrug: Acetaminophen (or equivalent)Drug: Dexamethasone (or equivalent)Drug: Steroid Mouthwash (dexamethasone or equivalent)

Pemetrexed Plus Carboplatin

ACTIVE COMPARATOR

Participants receive, via IV infusion, 500 mg/m2 pemetrexed every 3 weeks (Days 1 and 22 of every 6-week cycle) plus area under the curve (AUC) 5 mg/mL\*min carboplatin every 3 weeks (Days 1 and 22 of every 6-week cycle for 4 doses), then 500 mg/m2 pemetrexed every 3 weeks until discontinuation criteria is met.

Drug: PemetrexedDrug: Carboplatin

Interventions

Sacituzumab tirumotecanBIOLOGICAL

4 mg/kg via IV infusion

Also known as: SKB264, MK-2870

Sacituzumab tirumotecan

PemetrexedDRUG

500 mg/m\^2 via IV infusion

Pemetrexed Plus Carboplatin

CarboplatinDRUG

AUC 5 mg/mL\*min via IV infusion

Pemetrexed Plus Carboplatin

H1 Receptor AntagonistDRUG