Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
750 (estimated)
Sponsor
Eikon Therapeutics · Industry
Who this trial is looking for
This trial is looking for adults with stage 4 non-small cell lung cancer. Participants will receive a treatment combining EIK1001, pembrolizumab, and chemotherapy to assess safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have stage 4 non-small cell lung cancer.
I can receive standard therapy with pembrolizumab and chemotherapy.
I have evidence that mutation-directed therapy is not needed.
I have at least one measurable tumor.
I have not received prior systemic therapy for advanced lung cancer.
I have an ECOG Performance Status of 0 or 1.
I have tumor tissue available for PD-L1 testing.
You may not be able to join if
I have small cell lung cancer.
I am currently in another clinical trial or have received investigational therapy within the last 4 weeks.
I have had major surgery in the last 3 weeks.
I have had a live-virus vaccination in the last 30 days.
I have received radiation therapy in the last 7 days.
I have completed palliative radiotherapy in the last 7 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.
Trial Locations
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Status
Eligibility Criteria
Key Inclusion Criteria:
1. Participant must be ≥ 18 years old at the time of signing the informed consent.
2. Participant has a life expectancy of at least 3 months.
3. Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered …
Key Inclusion Criteria:
1. Participant must be ≥ 18 years old at the time of signing the informed consent.
2. Participant has a life expectancy of at least 3 months.
3. Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC.
4. Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country.
5. Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
6. Participant has not received prior systemic therapy for advanced/metastatic NSCLC.
Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible.
7. Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
8. Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is \< 3yrs old).
Key Exclusion Criteria:
1. has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.
2. is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo.
3. has had major surgery (\< 3 weeks prior to the first dose of study intervention administration).
4. has received a live-virus vaccination within 30 days of the start of study intervention initiation.
5. has received radiation therapy within 7 days of the first dose of study intervention administration.
6. has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.
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