2025-525013-23-00招募中2 期
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 48
- 主要终点
- 1. PFS defined as the time from randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
研究概览
简要总结
To compare progression-free survival (PFS) of EIK1001 + pembrolizumab + NSQ/SQ chemotherapy to placebo + pembrolizumab NSQ/SQ chemotherapy according to RECIST 1.1 by BICR o Hypothesis 1 (H1): EIK1001 + pembrolizumab+ NSQ/SQ chemotherapy prolongs PFS compared to placebo + pembrolizumab + NSQ/SQ chemotherapy To compare overall survival (OS) of EIK1001 + pembrolizumab + NSQ/SQ chemotherapy to placebo + pembrolizumab + NSQ/SQ chemotherapy o Hypothesis 2 (H2): EIK1001 + pembrolizumab + NSQ/SQ chemotherapy prolongs OS compared to placebo + pembrolizumab + NSQ/SQ chemotherapy To evaluate efficacy and safety of 2 doses of EIK1001 in combination with pembrolizumab and NSQ/SQ chemotherapy (Dose Optimization Only)
研究设计
- 分配方式
- Randomized
- 主要目的
- Part 1 Dose Optimization
- 盲法
- Double (Carer, Monitor, Investigator, Subject, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 18 years old at the time of signing the informed consent.
- •Participant has a life expectancy of at least 3 months.
- •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.
- •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.
- •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.
- •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.
- •Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
- •Participant has tumor tissue available 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).
- •Participant has an adequate organ and marrow function as defined in Table
- •Specimens must be collected within 10 days prior to the start of study intervention.
排除标准
- •has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.
- •has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention. Participants with known untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion > 1.5 cm) may participate but will require regular imaging of the brain as a site of disease.
- •has a severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients or a known sensitivity to any component of carboplatin, cisplatin, paclitaxel, nabpaclitaxel or pemetrexed.
- •has non-squamous NSCLC and is receiving pemetrexed and: • is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤ 1.3 g per day, for a 5-day period preceding each dose (8day period for long-acting agents, such as piroxicam). •is unable or unwilling to take folic acid or vitamin B12 supplementation. • has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
- •has a mean resting QTcF > 470 ms obtained from a single 12-lead ECG at Screening
- •has active autoimmune disease that has required systemic treatment in the past 2 years Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
- •has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •is on chronic systemic steroids. Note: Participants that require intermittent use of bronchodilators, inhaled topical or local steroid injections for any clinical indications are eligible.
- •has an active infection requiring therapy.
- •has uncontrolled human immunodeficiency virus (HIV) infection. To be eligible, HIV-infected participants must have well-controlled HIV defined by: • a CD4+ T-cell count ≥ 350 cells/mm 3 at the time of screening, • absence of any AIDS-defining opportunistic infections within the past 12 months, and • a stable anti-retroviral therapy (ART) regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry and agreement by the prospective participant to continue ART throughout the study. For patients on ART: • please check with the Sponsor to confirm that ART will not exhibit DDI with EIK
- •has HIVinfection and a history of Kaposi’s sarcoma and/or multicentric Castleman’s disease.
- •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.
- •has a positive test result for hepatitis B virus (HBV) or HCV indicating the presence of virus (it is expected that all participants will have been serologically tested for hepatitis B in advance of this study, with HBsAg, anti-HBc IgG, and anti-HBs as per ASCO 2020 Provisional Clinical Opinion on universal Serologic testing for hepatitis B at the onset of anticancer therapy (Hwang et al., 2020); screening should also include an anti-HCV test ordered before start of cancer treatment (Hwang et al., 2014): Of note, some caveats about Hepatitis B and C infections to consider: • Active HBV infection (chronic or acute; defined as having a known positive hepatitis B surface antigen [HBsAg] test at the time of Screening) is exclusionary except for participants on anti-viral therapy for HBV with an undetectable or low viral load. • Participants with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible if HBV DNA is negative. • Participants positive for HCV antibody are excluded unless polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Note: A participant’s HBV or HCV status should be recorded as medical history.
- •has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or that, in the opinion of the treating Investigator, deems it not in the best interest of the participant to participate.
- •22.has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
- •is, at the time of signing informed consent, a known regular user of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
- •has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- •has a history of allogenic/organ solid tissue transplant.
- •is pregnant or breastfeeding, expecting to conceive, breastfeed, or father children within the projected duration of the study.
- •is currently receiving medications known to be strong inhibitor or inducer of CYP3A4 and CYP1A
- •Note: Table 6 acts as a guide for medications known to be inhibitors or inducers of CYP3A4 and CYP1A
- •This is in no way an exhaustive list, and each medication should be checked individually to ensure it is not a strong inhibitor or inducer of CYP3A4 or CYP1A
- •has had major surgery (< 3 weeks prior to the first dose of study intervention administration).
- •has received a live-virus vaccination within 30 days of the start of study intervention initiation.
- •has received radiation therapy within 7 days of the first dose of study intervention administration.
- •has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.
- •is expected to require any form of antineoplastic therapy while on study other than the study intervention.
- •has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or peritoneal carcinomatosis.
- •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. Note: this time requirement does not apply to the NSCLC tumor for which a participant is enrolled in the study, nor does it apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
研究组 & 干预措施
PEMBROLIZUMAB
Test
干预措施: PEMBROLIZUMAB (Drug)
Inactive control which is identical in appearance and composition as EIK1001 drug product except for the lack of EIK1001 drug substance
Placebo
干预措施: Inactive control which is identical in appearance and composition as EIK1001 drug product except for the lack of EIK1001 drug substance (Drug)
EIK1001 solution for injection 1.0 mg/mL free base equivalent
Test
干预措施: EIK1001 solution for injection 1.0 mg/mL free base equivalent (Drug)
结局指标
主要结局
1. PFS defined as the time from randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
1. PFS defined as the time from randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
2. OS defined as the time from randomization to death due to any cause Objective Response (OR; defined as participants who demonstrate CR or PR by RECIST 1.1 as assessed by the Investigator), AEs, and discontinuation of study intervention due to an AE (Dose Optimization Only)
2. OS defined as the time from randomization to death due to any cause Objective Response (OR; defined as participants who demonstrate CR or PR by RECIST 1.1 as assessed by the Investigator), AEs, and discontinuation of study intervention due to an AE (Dose Optimization Only)
次要结局
- 1. Objective Response (OR) defined as participants who demonstrate confirmed CR or PR according to RECIST 1.1 by BICR
- 2. DOR defined as the time from the first document edevidence of CR or PR until disease progression or death due to any cause, whichever occurs first, according to RECIST 1.1 by BICR
- 3. PFS, OR, and DOR according to RECIST 1.1 by Investigator
- 4. AEs and discontinuation of study intervention due to any AE
研究者
Nishitha Reddy
Scientific
Eikon Therapeutics Inc.
研究点 (48)
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