2024-513621-23-00招募中3 期
TACTI-004, a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (PD-1 antagonist) and chemotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Immutep
- 入组人数
- 363
- 试验地点
- 90
- 主要终点
- Overall survival (OS) is defined as the time from randomization to death from any cause.
研究概览
简要总结
To compare the efficacy of efti combined with pembrolizumab and chemotherapy compared to standard of care (SoC) in PD-L1 unselected population.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
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
- 是
入选标准
- •Willing to give written informed consent and to comply with the protocol.
- •Evidence of measurable disease as defined by RECIST 1.1 as determined by site.
- •Participants must have recovered from all AEs due to previous anticancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 ≤ Grade 1 or baseline. Participants with CTCAE ≤ Grade 2 neuropathy, alopecia, and elevated transaminases in case of liver metastases may be eligible.
- •Participants who received major surgery prior to trial start must have recovered adequately from the toxicity and/or complications from the intervention prior to starting trial treatment.
- •Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
- •Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Note: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization.
- •Human immunodeficiency virus (HIV) infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease defined as: a. Participants on ART must have a CD4+ T-cell count > 350 cells/mm3 at time of screening. b. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening. c. Participants on ART must have been on stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to cycle 1 day
- •d. It is advised that participants must not have had any acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months. e. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors/inducers/substrates.
- •Adequate organ function as defined in the protocol. Specimens must be collected within 10 days before randomization.
- •Histologically- or cytologically-confirmed diagnosis of advanced or metastatic (stage IIIB/C or stage IV) NSCLC not amenable to curative treatment or locally available oncogenic driver mutation-based first-line therapy, treatment naïve for systemic therapy given for advanced/metastatic disease (previous palliative radiotherapy for advanced/metastatic disease acceptable).
- •Archival tumor tissue sample or newly obtained core, or excisional biopsy of a tumor lesion not previously irradiated has been provided. Details pertaining to tumor tissue submission can be found in the Laboratory Manual.
- •Availability of PD-L1 biomarker result from central laboratory, using the FDA approved Dako standardized diagnostic test (PD-L1 IHC 22C3 pharmDx).
- •Be ≥ 18 years of age on the day of signing the informed consent.
- •If assigned male at birth, the participant agrees to the following during the intervention period and for at least the time needed to eliminate the following interventions after the last dose of the specified trial intervention. The length of time required to continue contraception for trial interventions is: • cisplatin: 100 days • carboplatin: 100 days • pemetrexed: 100 days • paclitaxel: 100 days - Refrains from donating sperm PLUS either: - Abstains from intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR - Uses a penile/external condom when having intercourse PLUS partner of childbearing potential who is not currently pregnant should use an additional contraceptive method (refer to Protocol Section 5.13), as a condom may break or leak. - Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. If the contraception requirements in the local label for any of the trial interventions are more stringent than the requirements above, the local label requirements are to be followed.
- •A participant of childbearing potential (POCBP) is eligible to participate if not pregnant and a negative pregnancy test before the first dose of trial intervention has been obtained. Additional requirements for pregnancy testing during and after trial intervention are in Contraception Methods. - A POCBP is eligible to participate if not breastfeeding during the trial intervention period and as defined in the protocol. - A POCBP is eligible to participate if a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency is used, or penile-vaginal intercourse abstinence, as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), is adhered to as described in Protocol Section 5.13 during the intervention period and for at least the time needed to eliminate each trial intervention after the last dose of trial intervention. In addition, the participant agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of reproduction. The length of time required to continue contraception for each trial intervention is defined in the protocol.
- •An ECOG performance status of 0 to 1 assessed within 7 days before randomization.
- •Expected survival > 3 months.
排除标准
- •Is expected to require any other form of systemic or localized antineoplastic therapy (other than the trial treatment) while on trial (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection).
- •Evidence of severe or uncontrolled cardiac disease within 6 months prior to first dose of trial treatment including: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade ≥ 2, atrial fibrillation > Grade 2 not controlled by a pacemaker, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
- •History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- •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 trial intervention.
- •Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
- •HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- •History of allogenic tissue/solid organ transplant.
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Has hypersensitivity to eftilagimod alfa and/or pembrolizumab (≥Grade 3) and/or any of its excipients.
- •Has hypersensitivity to any component of planned platinum-based doublet chemotherapy and/or any of its excipients.
- •Received prior radiotherapy within 2 weeks of start of trial intervention, or has radiation-related toxicities, requiring corticosteroids.
- •Received a live or live-attenuated vaccine within 30 days before the first dose of trial intervention. Administration of killed vaccines is allowed. Refer to Protocol Section 5.10 for information on COVID-19 vaccines.
- •Has a life-threatening illness unrelated to cancer.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant’s participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
- •Participants whose tumor harbors any of the following actionable molecular alterations: a. epidermal growth factor receptor (EGFR)-sensitizing (activating) mutation; b. anaplastic lymphoma kinase (ALK) gene fusion positive (ALK translocation); c. c-ROS oncogene 1 (ROS1) translocation.
- •For any indication has received any of the following therapies: a. within 3 weeks prior to cycle 1 day 1: systemic cytotoxic chemotherapy, targeted small molecule therapy (e.g. kinase inhibitors), biological therapy, any other systemic cancer therapy, or had major surgery; b. within 4 weeks prior to cycle 1 day 1 has been treated with an investigational agent or has used an investigational device, or is still a participant in the active phase of an investigational trial; c. within 6 months prior to cycle 1 day 1 received lung radiation therapy of >30 Gray (Gy).
- •Has received any treatment as part of adjuvant, neoadjuvant therapy or definitive chemoradiation for the treatment of NSCLC within 12 months prior to the diagnosis of advanced/metastatic disease.
- •Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) or lymphocyte activation gene 3 (LAG-3) targeting therapy (e.g., anti-LAG-3 antibodies). Note: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent for nonmetastatic resectable NSCLC (e.g. in the neoadjuvant or adjuvant setting) or following definitive chemoradiation, is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
- •Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
- •Known active central nervous system (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 trial screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of trial intervention. Note: Participants with available neuroimaging performed as routine clinical management before the Screening imaging may be enrolled using this exception and compared to the imaging conducted at Screening.
- •Active infection requiring parenteral systemic therapy within 4 weeks prior to cycle 1 day 1 and/or significant acute or chronic infection in screening and/or on cycle 1 day 1.
结局指标
主要结局
Overall survival (OS) is defined as the time from randomization to death from any cause.
Overall survival (OS) is defined as the time from randomization to death from any cause.
PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), defined as the time from randomization to documented disease progression or death from any cause as assessed by the Investigator assessment based on RECIST.
PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), defined as the time from randomization to documented disease progression or death from any cause as assessed by the Investigator assessment based on RECIST.
次要结局
- ORR according to RECIST 1.1 by Investigator assessment defined as the proportion of participants who have best overall confirmed response (BOR) of complete response (CR) or partial response (PR).
- Frequency, severity, and duration of adverse events (AEs), and clinically relevant abnormalities in vital signs, physical examinations, 12-lead electrocardiograms (ECGs), and safety laboratory assessments.
- DCR according to RECIST 1.1 by Investigator assessment defined as the proportion of participants who have BOR of confirmed CR or confirmed PR or stable disease (SD) (for ≥ 6 weeks).
- DOR is defined as the time from the date a response of confirmed CR or confirmed PR was first documented until the date of the first documentation of disease progression.
- TTR is defined as the time from the date of first treatment to the date of the first documented confirmed CR or confirmed PR.
- TTNT defined from the date of randomization to the date of any post-trial procedure or therapy for the same disease.
- Changes from baseline in QoL as assessed by European Organization For Research And Treatment Of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30); EORTC QLQ-LC13 and EuroQol 5 Dimension 5 Level (EQ-5D-5L).
- PFS2 defined as the time from randomization to disease progression or death from any cause (whichever occurs first) on next-line treatment.
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