Active Not Recruiting PHASE1 INTERVENTIONAL 5-arm NCT05650879

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer (HER2)

A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients With HER2 Mutant Non-Small Cell Lung Cancer

Sponsor: Enliven Therapeutics

Conditions HER2 Amplification HER2 Gene Mutation HER2 Mutant Non-small Cell Lung Cancer HER2-positive Metastatic Breast Cancer

Interventions ELVN-002 Fam-Trastuzumab Deruxtecan-Nxki Trastuzumab emtansine

Updated 21 times since 2023 Last updated: Jul 10, 2025 Started: Mar 20, 2023 Primary completion: Jul 31, 2026 Completion: Jul 31, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on HER2 Amplification and HER2 Gene Mutation, this trial is ongoing. The trial is conducted by Enliven Therapeutics and has accumulated 21 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

21 versions recorded

Dec 2025 — Present [monthly]

Active Not Recruiting PHASE1
Sep 2025 — Dec 2025 [monthly]

Active Not Recruiting PHASE1
Aug 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE1
Jul 2025 — Aug 2025 [monthly]

Active Not Recruiting PHASE1

Status: Recruiting → Active Not Recruiting
Feb 2025 — Jul 2025 [monthly]

Recruiting PHASE1

▶ Show 16 earlier versions

Nov 2024 — Feb 2025 [monthly]

Recruiting PHASE1
Sep 2024 — Nov 2024 [monthly]

Recruiting PHASE1
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE1
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE1
Apr 2024 — Jun 2024 [monthly]

Recruiting PHASE1
Feb 2024 — Apr 2024 [monthly]

Recruiting PHASE1
Dec 2023 — Feb 2024 [monthly]

Recruiting PHASE1
Nov 2023 — Dec 2023 [monthly]

Recruiting PHASE1
Sep 2023 — Nov 2023 [monthly]

Recruiting PHASE1
Aug 2023 — Sep 2023 [monthly]

Recruiting PHASE1
Jul 2023 — Aug 2023 [monthly]

Recruiting PHASE1
Jun 2023 — Jul 2023 [monthly]

Recruiting PHASE1
May 2023 — Jun 2023 [monthly]

Recruiting PHASE1
Apr 2023 — May 2023 [monthly]

Recruiting PHASE1
Mar 2023 — Apr 2023 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting
Jan 2023 — Mar 2023 [monthly]

Not Yet Recruiting PHASE1

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Enliven Therapeutics

Data source: Enliven Therapeutics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ancona, Italy , Aurora, United States , Aviano, Italy , Barcelona, Spain , Bordeaux, France , Boston, United States , Caen, France , Candiolo, Italy , Darlinghurst, Australia , Dijon, France and 23 more locations