EIK1001 + Pembrolizumab and Chemotherapy for Non-Small Cell Lung Cancer

Recruiting at 40 trial locations

Overseen By Genevieve Doster

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eikon Therapeutics

Disqualifiers: Small cell elements, Prior malignancy, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EIK1001 (also known as BDB-001) combined with standard care for people with advanced non-small cell lung cancer (NSCLC). It targets those who haven't received previous treatments for their advanced cancer. Participants are divided into two groups: one with squamous NSCLC and one with non-squamous NSCLC, each receiving EIK1001 plus standard treatment. Suitable candidates have stage 4 NSCLC and have not undergone intravenous treatment (such as chemotherapy) for their advanced disease. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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 mentions that participants should not have received prior systemic treatment for advanced/metastatic NSCLC.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that EIK1001, when combined with pembrolizumab and chemotherapy, is generally safe. Patients in studies have tolerated the treatment well, with no serious safety issues reported. The side effects are manageable and can usually be addressed with standard medical care.

In one study, 64% of patients responded well to the combination treatment, indicating effectiveness for many while maintaining control over side effects. This suggests that while side effects may occur, they are typically not severe and can be managed with proper care.

Overall, EIK1001, when used with other treatments, appears safe based on current research. However, discussing potential risks and benefits with healthcare providers is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for non-small cell lung cancer?

Unlike the standard treatments for non-small cell lung cancer, which typically focus on chemotherapy and immunotherapy, EIK1001 introduces a new active ingredient that may enhance the body's immune response against cancer cells. Researchers are particularly excited because EIK1001, when combined with Pembrolizumab and chemotherapy, could improve treatment effectiveness and potentially offer better outcomes for patients with both squamous and non-squamous types of NSCLC. This innovative approach targets cancer cells more precisely, aiming to increase the chances of tumor reduction and improve overall survival rates.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that EIK1001, when combined with pembrolizumab and chemotherapy, may help treat advanced non-small cell lung cancer (NSCLC). In earlier studies, this combination led to a 64% overall response rate, with many patients experiencing tumor shrinkage. In this trial, participants in both Cohort A (non-squamous NSCLC) and Cohort B (squamous NSCLC) will receive EIK1001 along with the standard of care. EIK1001 enhances the immune system's ability to fight cancer and has been generally well-tolerated, with mild side effects. These findings suggest that EIK1001 could be a promising treatment option for people with advanced NSCLC. ^{1 3 4 6 7}

Who Is on the Research Team?

Etah Kurland, MD

Principal Investigator

Eikon Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with advanced stage 4 non-small cell lung cancer who haven't had intravenous treatment for their condition. Specific eligibility details are not provided, but typically participants need to meet certain health standards and may be excluded based on factors like other medical conditions or treatments.

Inclusion Criteria

My organs are functioning well.

I haven't had systemic treatment for advanced lung cancer.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

Is currently participating in or has participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001

My lung cancer is not mainly squamous or non-squamous cell type.

I have had treatment or major surgery for my cancer less than 3 weeks before starting EIK1001.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EIK1001 in combination with Pembrolizumab and Chemotherapy

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• EIK1001

Trial Overview The study tests a combination of EIK1001 with the immunotherapy drug Pembrolizumab and chemotherapy drugs Paclitaxel, Pemetrexed, and Carboplatin. It's likely that patients will be randomly assigned to receive either this combination or a standard treatment as part of the research.

How Is the Trial Designed?

Group I: Cohort B - Participants with squamous NSCLC Experimental Treatment 4 Interventions

Participants in this arm will receive EIK1001 + Standard of Care (SOC).

Group II: Cohort A - Participants with non-squamous NSCLC Experimental Treatment 4 Interventions

Participants in this arm will receive EIK1001 + Standard of Care (SOC).

Who Is Running the Clinical Trial?

Eikon Therapeutics

Lead Sponsor

Trials

8

Recruited

1,300+

Published Research Related to This Trial

In a study of 1,026 treatment-naïve patients with metastatic non-small-cell lung cancer (NSCLC) and PD-L1 expression of ≥50%, pembrolizumab showed an objective response rate of 44.5%, with median progression-free survival of 7.9 months and overall survival of 17.2 months.

Higher PD-L1 expression (≥90%) was linked to better treatment outcomes, while factors like poor performance status and the presence of bone or liver metastases were associated with worse clinical outcomes, indicating the importance of patient selection for pembrolizumab therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50. Cortellini, A., Tiseo, M., Banna, GL., et al.[2020]

Pembrolizumab, an anti-PD-1 antibody, has been approved for treating unresectable or metastatic melanoma, especially in patients who have progressed after ipilimumab treatment, marking a significant advancement in immuno-oncology.

The drug has also received breakthrough status for treating non-small cell lung cancer (NSCLC) that is EGFR mutation-negative and ALK rearrangement-negative, indicating its broad potential in cancer therapy, with ongoing trials to explore its use in various tumor types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab. Khoja, L., Butler, MO., Kang, SP., et al.[2022]

In a study of 100 patients with non-small cell lung cancer (NSCLC) treated with pembrolizumab, further stratification of PD-L1 tumor proportion score (TPS) beyond 50% did not significantly affect progression-free survival (PFS).

Smoking status was associated with improved PFS, while prior radiotherapy was linked to decreased PFS, indicating that these factors, along with performance status, may serve as important biomarkers for predicting response to pembrolizumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab monotherapy for non-small cell lung cancer (NSCLC): can patient stratification be improved in the UK Tayside population? A retrospective cohort study. Mander, ES., Merrick, CB., Nicholson, HA., et al.[2023]

Pembrolizumab, an immune checkpoint inhibitor for non-small cell lung cancer (NSCLC), has a favorable safety profile, with serious immune-related adverse events occurring in less than 10% of patients when used alone.

Monotherapy with pembrolizumab not only improves health-related quality of life compared to chemotherapy but also allows for effective management of immune-related adverse events, which are often reversible with proper treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of pembrolizumab for the treatment of non-small cell lung cancer. Mazarico Gallego, JM., Herrera Juárez, M., Paz-Ares, L.[2020]

A 68-year-old patient with stage IV lung adenocarcinoma showed an unexpected positive response to paclitaxel after failing treatment with pembrolizumab, an anti-PD-1 immunotherapy.

The patient experienced a response duration of over fourteen months with paclitaxel, suggesting that combining or sequencing chemotherapy with immunotherapy may enhance treatment effectiveness in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. Zapata, E., Mennecier, B., Leduc, C., et al.[2017]

Pembrolizumab, a monoclonal antibody targeting PD-1, has shown significant efficacy in treating advanced non-small-cell lung cancer (NSCLC) across multiple clinical trials, particularly in patients with PD-L1 expression levels of 1% or higher.

The KEYNOTE studies identified specific patient populations that benefit most from pembrolizumab, highlighting the importance of PD-L1 as a companion diagnostic, while future research will explore its role in earlier stages of cancer treatment and in combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab in lung cancer: current evidence and future perspectives. Palumbo, G., Carillio, G., Manzo, A., et al.[2020]

In a study of 72 treatment-naïve patients with advanced non-small cell lung cancer (NSCLC) and high PD-L1 expression, pembrolizumab showed an objective response rate of 45.8%, with even higher rates of 70.0% in patients with pre-existing interstitial lung disease (ILD).

Patients with ILD had similar overall survival rates compared to those without ILD, suggesting that pembrolizumab can be safely administered to NSCLC patients with ILD without compromising their prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-existing interstitial lung disease does not affect prognosis in non-small cell lung cancer patients with PD-L1 expression ≥50% on first-line pembrolizumab. Yamaguchi, O., Kaira, K., Shinomiya, S., et al.[2021]

In a study of 655 patients with advanced melanoma, pembrolizumab showed a 5-year overall survival rate of 34%, with even better outcomes (41%) for treatment-naive patients, indicating its long-term efficacy.

The treatment was generally well-tolerated, with 86% of patients experiencing treatment-related adverse events, but only 7.8% discontinued due to these effects, suggesting a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Hamid, O., Robert, C., Daud, A., et al.[2023]

Pembrolizumab is a safe and effective immune checkpoint inhibitor that targets the PD-1 receptor, currently approved for treating advanced melanoma and metastatic non-small cell lung cancer (NSCLC).

Ongoing studies are exploring the potential of pembrolizumab in combination with other treatments for lung cancer and other cancer types, while also investigating biomarkers that may predict patient response to this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of PD-L1 positive advanced or metastatic non-small cell lung cancer. Dang, TO., Ogunniyi, A., Barbee, MS., et al.[2020]

Pembrolizumab, a monoclonal antibody targeting PD-1, showed significant efficacy in treating a 79-year-old patient with advanced squamous cell lung cancer, leading to a complete response after just 3 cycles of treatment.

However, the patient developed acute myelomonocytic leukemia after starting pembrolizumab, highlighting a potential safety concern that warrants further investigation into the drug's effects on blood cell production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute myelomonocytic leukemia during pembrolizumab treatment for non-small cell lung cancer: A case report. Kim, HB., Park, SG., Hong, R., et al.[2020]

In a study of 566 patients with metastatic non-small cell lung cancer (NSCLC) treated with first-line pembrolizumab, the median overall survival was 19.6 months, with 3-year survival rates of 36.2%, indicating promising long-term outcomes in a real-world setting.

The study found that 38.6% of patients experienced a real-world tumor response, with the most common reasons for discontinuation of treatment being disease progression and therapy-related adverse effects, highlighting the treatment's efficacy and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Real-World Outcomes of First-Line Pembrolizumab Monotherapy for Metastatic Non-Small Cell Lung Cancer With ≥50% Expression of Programmed Cell Death-Ligand 1. Velcheti, V., Hu, X., Yang, L., et al.[2022]

In a study of patients with advanced non-small-cell lung cancer (NSCLC) treated with pembrolizumab, a higher overall tumor burden was associated with a lower incidence of severe immune-related adverse events (irAEs), suggesting that tumor size may influence treatment safety.

Good performance status and high PD-L1 expression were significant predictors of developing severe irAEs, with odds ratios of 3.27 and 4.44, respectively, indicating that patients with these characteristics should be closely monitored during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for severe immune-related adverse events after first-line pembrolizumab monotherapy or combination chemotherapy for non-small-cell lung cancer. Sumi, T., Koshshino, Y., Sekikawa, M., et al.[2022]

In a Phase 2 study involving 35 patients with non-small cell lung cancer, neoadjuvant pembrolizumab was found to be safe and well tolerated, with only one surgery delay due to thyroiditis and no mortality within 90 days post-surgery.

The study showed a high rate of R0 resection (88%) and a major pathologic response in 28% of patients, indicating that pembrolizumab may be more effective than standard neoadjuvant chemotherapy in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer. Tong, BC., Gu, L., Wang, X., et al.[2022]

Citations

1. eikontx.com eikontx.com/news/eikon-therapeutics-to-present-new-phase-2-data-on-eik1001-in-first-line-non-small-cell-lung-cancer-at-esmo-2025/

Eikon Therapeutics to Present New Phase 2 Data ... “EIK1001 represents a unique approach to stimulating the immune system, and we are encouraged by its potential to improve outcomes for patients ...

2. onclive.com onclive.com/view/frontline-eik1001-plus-chemoimmunotherapy-stimulates-antitumor-activity-in-advanced-nsclc

Frontline EIK1001 Plus Chemoimmunotherapy Stimulates ... EIK1001 plus pembrolizumab and chemo showed a 64% ORR and manageable safety in first-line stage IV NSCLC, per phase 2 TeLuRide-005 data.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06246110

NCT06246110 | A Phase 2 Study of EIK1001 in Combo ... This is a multicenter open-label phase 2 trial that aim to assess the safety, tolerability, and efficacy of EIK1001 in combination with standard of care in ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS8667

A phase 2 study of EIK1001, a Toll-like receptor 7/8 (TLR7 ... The primary objective of this study is to determine the safety and tolerability of EIK1001 in combination with pembrolizumab and chemotherapy.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2521

Safety and preliminary efficacy of EIK1001 in combination ... Overall, EIK1001 was well-tolerated with a manageable safety profile and showed encouraging preliminary efficacy across several tumor types in combination with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06246110

NCT06246110 | A Phase 2 Study of EIK1001 in Combo ... This is a multicenter open-label phase 2 trial that aim to assess the safety, tolerability, and efficacy of EIK1001 in combination with standard of care in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11861325/

Emerging Immunotherapies for Advanced Non-Small-Cell ... This review aims to summarize the currently available ICIs for advanced NSCLC and describe emerging immunotherapies with recently published data from phase I/II ...