A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer. (TeLuRide-008)

Eikon Therapeutics

Status and phase: Begins enrollment in 3 months; Phase 3; Phase 2

Conditions: Stage 4 NSCLC; Non Small Cell Lung Cancer (Squamous or Non Squamous)

Treatments: Drug: Pemetrexed + Cisplatin /Carboplatin; Drug: Placebo; Drug: Pembrolizumab (KEYTRUDA®); Drug: Nab-paclitaxel + Carboplatin; Drug: Paclitaxel + Carboplatin; Drug: EIK1001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07365319

2025-525013-23-00 (EU Trial (CTIS) Number)

EIK1001-008

KEYNOTE-G57 (Other Identifier)

MK-3475-G57 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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750 participants in 3 patient groups, including a placebo group

Arm 1 (Placebo in Combination with SOC)

Placebo Comparator group

Description:

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

Treatment:

Drug: Paclitaxel + Carboplatin

Drug: Nab-paclitaxel + Carboplatin

Drug: Pembrolizumab (KEYTRUDA®)

Drug: Pemetrexed + Cisplatin /Carboplatin

Drug: Placebo

Arm 2 (EIK1001 in Combination with SOC)

Experimental group

Description:

Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).

Treatment:

Drug: EIK1001

Drug: Paclitaxel + Carboplatin

Drug: Nab-paclitaxel + Carboplatin

Drug: Pembrolizumab (KEYTRUDA®)

Drug: Pemetrexed + Cisplatin /Carboplatin

Arm 3 (EIK1001 in Combination with SOC)

Experimental group

Description:

Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).

Treatment:

Drug: EIK1001

Drug: Paclitaxel + Carboplatin

Drug: Nab-paclitaxel + Carboplatin

Drug: Pembrolizumab (KEYTRUDA®)

Drug: Pemetrexed + Cisplatin /Carboplatin