NSCLCPhase 2NCT06246110
A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
A Phase 2 study testing EIK1001, Pembrolizumab and Paclitaxel in people with NSCLC, run by Eikon Therapeutics at 38 sites in United States.
Trial summary
This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- EIK1001, Pembrolizumab and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 38 sitesUnited States
- Study dates
- 6 Feb 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be ≥ 18 years of age on the day of signing of informed consent.
- confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care.
- have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy).
- have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment.
- have not received prior systemic treatment for advanced/metastatic NSCLC.
- have an ECOG Performance Status of 0 to 1.
- have adequate organ function.
Who cannot join
- does not have predominantly squamous cell or non-squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
- 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.
- prior to the first dose of EIK1001, has received prior systemic therapy for metastatic disease, or had major surgery (< 3 weeks prior to the first dose).
- has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
- has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years.
- has an active infection requiring therapy.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Messino Cancer Centers
Asheville, North Carolina, 28806
Atlanta Piedmont Hospital
Atlanta, Georgia, 30318
Texas Oncology, Austin
Austin, Texas, 78745
New York Cancer and Blood Specialists
Babylon, New York, 11702
Medstar Franklin Square Cancer Center at Loch Raven Campus
Baltimore, Maryland, 21237
Texas Oncology, Bedford
Bedford, Texas, 76022
Blue Ridge Cancer Care Oncology Associates SW VA
Blacksburg, Virginia, 24060
Gabrail Cancer Center
Canton, Ohio, 44718
Ironwood Cancer and Research Center
Chandler, Arizona, 85224
Maryland Oncology
Columbia, Maryland, 20144
Southern Cancer Care
Daphne, Alabama, 36608
Willamette Valley
Eugene, Oregon, 97401
Virginia Cancer Specialists
Fairfax, Virginia, 22031
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
California Cancer Care Associates for Research & Excellence
Fresno, California, 93720
Bioresearch Partner
Hialeah, Florida, 33013
Memorial Cancer Institute
Hollywood, Florida, 33021
Kaiser Permanente Hawaii
Honolulu, Hawaii, 96819
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
Rocky Mountain Cancer
Lone Tree, Colorado, 80124
California Research Institute
Los Angeles, California, 90027
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Baptist Cancer Center
Memphis, Tennessee, 38120
Jersey Shore University Medical Center/Meridian Hematology & Oncology
Neptune City, New Jersey, 07753
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Weil Cornell Medical Center
New York, New York, 10022
Illinois Cancer Specialists
Niles, Illinois, 60714
Providence St Joseph Hospital, Center for Cancer Prevention and Treatment
Orange, California, 92868
Mid-Florida Hematology and Oncology Center
Orange, Florida, 32763
Orlando Health Cancer Institute
Orlando, Florida, 32806
Health Midwest Oncology Associates of Kansas
Overland Park, Kansas, 66211
Sutter Health Institute for Medical Research
Sacramento, California, 95816
Albert Einstein College of Medicine, Jacobi Medical Center
The Bronx, New York, 10461
Accelacare of Duly
Tinley Park, Illinois, 60487
Cancer and Blood Specialists of New York, White Plains Hospital
White Plains, New York, 10601
Cancer Center of Kansas
Wichita, Kansas, 67214
Shenandoah Oncology
Winchester, Virginia, 22601
About this study
Official title: A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer
This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease.
Read the detailed description
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 participants with both confirmed stage 4 squamous and non-squamous NSCLC who have not received prior systemic therapy for the advanced disease. The study includes dose finding and evaluates adverse events and efficacy.
- Conditions
- NSCLC
- Being tested
- EIK1001, Pembrolizumab, Paclitaxel, Pemetrexed, Carboplatin
- Keywords
- Squamous, Nonsquamous, Metastatic
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIK1001Drug
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
PembrolizumabDrug
PD-1 inhibitor
PaclitaxelDrug
Chemotherapy
PemetrexedDrug
Chemotherapy
CarboplatinDrug
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Participants with non-squamous NSCLC | Experimental | Participants in this arm will receive EIK1001 + Standard of Care (SOC). Receives: Drug: EIK1001; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin |
| Cohort B - Participants with squamous NSCLC | Experimental | Participants in this arm will receive EIK1001 + Standard of Care (SOC). Receives: Drug: EIK1001; Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with safety event during treatment
Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity.
Measured: Up to 2 years
Secondary outcomes (1)
Percentage of participants with objective response rate (ORR) and duration of response (DOR).
Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) by RECIST 1.1 and DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, as assessed by the investigator.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start6 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eikon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Etah Kurland, MD, Study director, Eikon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246110
- Sponsor's protocol ID
- EIK1001-005
- Status last verified
- May 2026
- First submitted
- 30 Jan 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06246110
- Acronym / sponsor ID
- EIK1001-005
- Conditions
- NSCLC
- Keywords
- Squamous, Nonsquamous, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Eikon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease.
Detailed description
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 participants with both confirmed stage 4 squamous and non-squamous NSCLC who have not received prior systemic therapy for the advanced disease. The study includes dose finding and evaluates adverse events and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Participants with non-squamous NSCLC | Experimental | Drug: EIK1001, Drug: Pembrolizumab, Drug: Pemetrexed, Drug: CarboplatinParticipants in this arm will receive EIK1001 + Standard of Care (SOC). |
| Cohort B - Participants with squamous NSCLC | Experimental | Drug: EIK1001, Drug: Pembrolizumab, Drug: Paclitaxel, Drug: CarboplatinParticipants in this arm will receive EIK1001 + Standard of Care (SOC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be ≥ 18 years of age on the day of signing of informed consent.
- confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care.
- have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy).
- have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment.
- have not received prior systemic treatment for advanced/metastatic NSCLC.
Key exclusion criteria (6 listed)
- does not have predominantly squamous cell or non-squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
- 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.
- prior to the first dose of EIK1001, has received prior systemic therapy for metastatic disease, or had major surgery (< 3 weeks prior to the first dose).
- has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
- has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIK1001EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist | Drug | Cohort A - Participants with non-squamous NSCLC, Cohort B - Participants with squamous NSCLC |
| PembrolizumabPD-1 inhibitor | Drug | Cohort A - Participants with non-squamous NSCLC, Cohort B - Participants with squamous NSCLC |
| PaclitaxelChemotherapy | Drug | Cohort B - Participants with squamous NSCLC |
| PemetrexedChemotherapy | Drug | Cohort A - Participants with non-squamous NSCLC |
| CarboplatinChemotherapy | Drug | Cohort A - Participants with non-squamous NSCLC, Cohort B - Participants with squamous NSCLC |
Primary outcome
Percentage of participants with safety event during treatment
Time frame: Up to 2 years
Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity.
1 secondary outcome
Percentage of participants with objective response rate (ORR) and duration of response (DOR).
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
Related trials for NSCLC
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etah Kurland, MD study director
Eikon Therapeutics
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EIK1001, Pembrolizumab and Paclitaxel in people with NSCLC, run by Eikon Therapeutics at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with safety event during treatment (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.