198 Participants Needed

ELVN-002 for Non-Small Cell Lung Cancer

(HER2 Trial)

Recruiting at 39 trial locations
HL
ST
Overseen BySabine Tricon
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Enliven Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ELVN-002, a new drug, in people with cancers that have an abnormal HER2 gene. It aims to see if the drug is safe and can shrink these tumors, especially in advanced stage solid tumors and non-small cell lung cancer.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that you should not have taken certain HER2 tyrosine kinase inhibitors before joining the trial.

What data supports the effectiveness of the drug ELVN-002 for non-small cell lung cancer?

Nivolumab, a drug similar to ELVN-002, has shown some effectiveness in treating non-small cell lung cancer by enhancing the immune system's ability to fight cancer, with an objective response rate of 18% and a 1-year overall survival rate of 45% in patients.12345

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, particularly non-small cell lung cancer (NSCLC), that have HER2 mutations and have progressed after standard treatments or are unsuitable for them. Participants must be in good physical condition with proper heart function and adequate blood counts. Those with brain lesions needing immediate treatment, active infections, uncontrolled seizures, certain heart conditions, or another active cancer within the last 2 years cannot join.

Inclusion Criteria

You should have good overall health, normal heart function, and specific levels of blood cells, liver function, and kidney function.
My advanced NSCLC has worsened after treatment and has a HER2 mutation but no EGFR, ROS1, ALK, or BRAF V600E mutations.
My advanced cancer has not responded to standard treatments and is HER2 positive.
See 2 more

Exclusion Criteria

I have ongoing liver problems.
I haven't had any cancer except for basal cell skin cancer or in situ carcinoma in the last 2 years.
My cancer has spread to the lining of my brain and spinal cord.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 involves dose escalation with ELVN-002 monotherapy for patients with advanced stage solid tumors with HER2 mutation, amplification, or high HER2 over-expression.

Until disease progression or discontinuation

Dose Exploration

Part 2 involves dose exploration where additional patients may be enrolled at dose levels that have cleared the dose escalation to further evaluate safety, tolerability, pharmacokinetics, and clinical activity.

Until disease progression or discontinuation

Dose Expansion

Part 3 is a dose expansion of ELVN-002 monotherapy enrolling up to 40 patients with advanced stage HER2 mutant non-small cell lung cancer.

Until disease progression or discontinuation

Combination Dose Escalation

Part 4 involves combination dose escalation with ELVN-002 and either fam-trastuzumab deruxtecan-nxki or trastuzumab emtansine, based on results from Parts 1 and 2.

Until disease progression or discontinuation

Follow-up

Participants are monitored for safety and effectiveness after treatment.

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • ELVN-002
Trial Overview The trial is testing ELVN-002's safety at various doses in patients with HER2 gene abnormalities. It will also measure how much of the drug stays in the blood over time and whether it effectively shrinks tumors. Some participants will receive ELVN-002 alone while others may get it alongside other drugs like Fam-Trastuzumab Deruxtecan-Nxki depending on their specific type of cancer.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Phase 1b Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Group II: Phase 1a Monotherapy Dose ExplorationExperimental Treatment1 Intervention
Group III: Phase 1a Monotherapy Dose EscalationExperimental Treatment1 Intervention
Group IV: Phase 1a Combination Dose Escalation with T-DXdExperimental Treatment2 Interventions
Group V: Phase 1a Combination Dose Escalation with T-DM1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Enliven Therapeutics

Lead Sponsor

Trials
4
Recruited
670+

Published Research Related to This Trial

In a study of 1064 patients with left-sided non-small cell lung cancer (NSCLC), those who underwent 4L node dissection (4LND) had significantly better disease-free survival (DFS) and overall survival (OS) compared to those who did not, with 5-year DFS rates of 52.6% versus 46.7% and OS rates of 65.8% versus 56.3%.
The benefits of 4LND were particularly pronounced in patients with stage II and advanced stage disease, suggesting that 4LND should be considered a standard procedure for these patients to improve their survival outcomes.
Survival Benefit of Left Lower Paratracheal (4L) Lymph Node Dissection for Patients with Left-Sided Non-small Cell Lung Cancer: Once Neglected But of Great Importance.Zhao, K., Wei, S., Mei, J., et al.[2019]
In a study of 69 patients with advanced non-small cell lung cancer, higher nivolumab clearance rates at the first dose were associated with a significantly increased risk of death, indicating that nivolumab clearance can be a prognostic indicator for survival.
The study found that while nivolumab clearance showed high sensitivity as a biomarker for predicting outcomes, its specificity was low, suggesting that while it can identify patients at risk, it may not effectively distinguish between responders and non-responders.
Prognostic Value of Nivolumab Clearance in Non-Small Cell Lung Cancer Patients for Survival Early in Treatment.Otten, LS., Piet, B., van den Haak, D., et al.[2023]
In a study of 74 patients with metastatic non-small cell lung cancer (NSCLC) enrolled in early phase immunotherapy trials, those who had not previously received immunotherapy had a median overall survival (mOS) of 8.2 months, while those who had progressed on prior immunotherapy had a slightly better mOS of 10.5 months, indicating that prior treatment may not significantly hinder subsequent immunotherapy effectiveness.
Prognostic scores, particularly the Royal Marsden Hospital (RMH) score and the MD Anderson Cancer Center (MDACC) score, were effective in predicting overall survival, with a high ANC/ALC ratio (NLR) indicating poorer outcomes, suggesting that these scores can help identify patients who may not benefit from early phase immunotherapy.
Predicting outcomes in patients with advanced non-small cell lung cancer enrolled in early phase immunotherapy trials.Maymani, H., Hess, K., Groisberg, R., et al.[2022]

Citations

Survival Benefit of Left Lower Paratracheal (4L) Lymph Node Dissection for Patients with Left-Sided Non-small Cell Lung Cancer: Once Neglected But of Great Importance. [2019]
Prognostic Value of Nivolumab Clearance in Non-Small Cell Lung Cancer Patients for Survival Early in Treatment. [2023]
Predicting outcomes in patients with advanced non-small cell lung cancer enrolled in early phase immunotherapy trials. [2022]
The benefit and risk of nivolumab in non-small-cell lung cancer: a single-arm meta-analysis of noncomparative clinical studies and randomized controlled trials. [2019]
Comparative analysis of methodologies for predicting overall survival in patients with non-small cell lung cancer based on the number and rate of resected positive lymph nodes: A study based on the SEER database for 2010 through 2019. [2023]
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