NCT06074588

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)

Recruiting now Phase 3 Last updated 13 February 2026

What this trial tests

Phase 3 trial testing Sacituzumab tirumotecan in Non-small Cell Lung Cancer (NSCLC) in 556 participants. Currently enrolling.

Timeline

12 November 2023

Primary endpoint
10 May 2027

11 March 2030

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	556
Start date	12 November 2023
Primary completion	10 May 2027
Estimated completion	11 March 2030
Sites	192 locations across Hong Kong, Italy, Japan, Malaysia, Taiwan, Vietnam, Poland, South Korea

Drugs / interventions tested

• Sacituzumab tirumotecan — full drug profile →
• Docetaxel (Docetaxel) — full drug profile →
• Pemetrexed — full drug profile →

Conditions studied

• Non-small Cell Lung Cancer (NSCLC) — all drugs for Non-small Cell Lung Cancer (NSCLC) →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibody-Drug Conjugates (ADCs): current and future biopharmaceuticals.
   Wang R, Hu B, Pan Z, Mo C, et al · · 2025 · cited 105× · PMID 40307936 · DOI 10.1186/s13045-025-01704-3
2. Antibodies to watch in 2025.
   Crescioli S, Kaplon H, Wang L, Visweswaraiah J, et al · · 2025 · cited 87× · PMID 39711140 · DOI 10.1080/19420862.2024.2443538
3. Mechanisms of resistance to tyrosine kinase inhibitor-targeted therapy and overcoming strategies.
   Ou X, Gao G, Habaz IA, Wang Y. · · 2024 · cited 30× · PMID 39184861 · DOI 10.1002/mco2.694
4. Sacituzumab tirumotecan versus docetaxel for previously treated <i>EGFR</i>-mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial.
   Fang W, Li X, Wang Q, Meng X, et al · · 2025 · cited 19× · PMID 40473437 · DOI 10.1136/bmj-2025-085680
5. Current Status and Future Prospects of TROP-2 ADCs in Lung Cancer Treatment.
   Li M, Jin M, Peng H, Wang H, et al · · 2024 · cited 15× · PMID 39525044 · DOI 10.2147/dddt.s489234
6. Targeted therapy of non-small cell lung cancer: mechanisms and clinical trials.
   Yu L, Yang R, Long Z, Tao Q, et al · · 2024 · cited 12× · PMID 39391239 · DOI 10.3389/fonc.2024.1451230
7. Advancements in antibody-drug conjugates as cancer therapeutics.
   Fong JY, Phuna Z, Chong DY, Heryanto CM, et al · · 2025 · cited 11× · PMID 40814440 · DOI 10.1016/j.jncc.2025.01.007
8. Future AI Will Most Likely Predict Antibody-Drug Conjugate Response in Oncology: A Review and Expert Opinion.
   Sobhani N, D'Angelo A, Pittacolo M, Mondani G, et al · · 2024 · cited 10× · PMID 39272947 · DOI 10.3390/cancers16173089