EIK1001 + Pembrolizumab + Chemotherapy for Lung Cancer
(TeLuRide-008 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new treatment called EIK1001 for individuals with stage 4 non-small cell lung cancer (NSCLC). The study examines EIK1001, an experimental treatment, combined with pembrolizumab and chemotherapy to determine if it outperforms standard treatments alone. Participants will join one of three groups: receiving EIK1001 at varying doses or a placebo, all alongside standard care. The trial seeks individuals with confirmed stage 4 NSCLC who have not received previous systemic treatment for their advanced cancer. As a Phase 2, Phase 3 trial, this research evaluates the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies found that the combination of EIK1001 with pembrolizumab and chemotherapy was generally well-tolerated by patients. Research shows that this combination had a manageable safety profile, with side effects present but not too severe for most people. Specifically, one study found that 64% of patients with stage IV NSCLC responded to the treatment without a significant increase in negative side effects. This suggests that while side effects occur, they are similar to or less than what is typically expected with such treatments. The focus remains on providing effective treatment while keeping side effects manageable.12345
Why are researchers excited about this trial's treatments for lung cancer?
Researchers are excited about EIK1001 because it represents a novel approach to treating lung cancer. Unlike standard treatments such as chemotherapy and immunotherapy, EIK1001 targets cancer cells with a new mechanism that may enhance the effectiveness of existing therapies like Pembrolizumab. The treatment is being tested in different doses to find the optimal balance between efficacy and safety. This innovative strategy could potentially improve outcomes for patients by working synergistically with current standard-of-care treatments.
What evidence suggests that this trial's treatments could be effective for lung cancer?
Research has shown that EIK1001, when combined with pembrolizumab and chemotherapy, yields promising results for treating stage 4 non-small cell lung cancer (NSCLC). In this trial, participants in Arm 2 and Arm 3 will receive EIK1001 at varying doses alongside standard care treatments. One study found that 63% of patients with advanced NSCLC responded well to this treatment. Another study reported a 64% overall response rate, indicating that many patients experienced tumor shrinkage or halted tumor growth. The combination treatment has been well-tolerated, with manageable side effects. This suggests that EIK1001, together with standard treatments, could be an effective option for patients with this type of lung cancer.23567
Who Is on the Research Team?
Nishitha Reddy
Principal Investigator
Eikon Therapeutics
Are You a Good Fit for This Trial?
This trial is for adults (18+) with stage 4 non-small cell lung cancer who have not had prior treatment for advanced disease, do not have certain gene mutations, and are healthy enough to receive standard chemo and immunotherapy. They must have a tumor sample available for testing.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Optimization
Participants receive EIK1001 in combination with pembrolizumab and chemotherapy to determine the optimal dose
Dose Expansion
Participants continue receiving the optimized dose of EIK1001 with pembrolizumab and chemotherapy to further evaluate safety and efficacy
Confirmatory Hypothesis Testing
Participants are monitored for progression-free survival and overall survival to confirm the efficacy of the treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- EIK1001
- Nab-paclitaxel
- Paclitaxel
- Pembrolizumab
- Pemetrexed
Trial Overview
The study tests EIK1001 given by IV along with pembrolizumab (an immunotherapy) and chemotherapy. Some participants get EIK1001 while others get a placebo, all combined with standard treatments. The goal is to see if adding EIK1001 improves outcomes.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).
Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).
Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eikon Therapeutics
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
1850MO TeLuRide-005: Phase II study of EIK1001, a toll- ...
1L therapy using EIK1001 combined with chemo + ICIs produced a substantial response rate (63%) in advanced NSCLC and did not increase adverse event rates ...
2.
onclive.com
onclive.com/view/frontline-eik1001-plus-chemoimmunotherapy-stimulates-antitumor-activity-in-advanced-nsclcFrontline 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.
NCT07365319 | A Safety and Efficacy Study of EIK1001 in ...
This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate ...
Emerging Immunotherapies for Advanced Non-Small-Cell ...
Overall lung cancer mortality is declining in economically developed countries, likely due both to a reduction in incidence and improved survival related to ...
EIK1001 + Pembrolizumab and Chemotherapy for Non- ...
Pembrolizumab, a monoclonal antibody targeting PD-1, has shown significant efficacy in treating advanced non-small-cell lung cancer (NSCLC) across multiple ...
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 ...
Eikon Therapeutics to Present New Phase 2 Data ...
The trial's primary objective is to evaluate the safety and tolerability of EIK1001 in the triplet combination. In addition, Eikon hopes to ...
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