Last updated 22 days ago

Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004)

756 patients around the world

Available in Chile

TACTI-004 is a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (major histocompatibility complex (MHC) class II agonist) in combination with pembrolizumab (programmed cell death protein 1 (PD-1) antagonist) and chemotherapy. The proposed clinical trial aims to compare the efficacy and to demonstrate the superiority of efti combined with standard of care (SoC, pembrolizumab and histology-based chemotherapy) compared to placebo combined with SoC in programmed death-ligand 1 (PD-L1) unselected population as assessed by: - Overall survival [OS] - Progression-free survival [PFS] per RECIST 1.1 The trial is planned to be conducted in countries in Asia, Australia, Europe and North and South America in approximately 175 experienced clinical sites.

Immutep S.A.S.

756Patients around the world

This study is for people with

Lung cancer

Non-small cell lung carcinoma

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: Willing to give written informed consent and to comply with the protocol.
Histologically- or cytologically-confirmed diagnosis of advanced or metastatic (stage IIIB/C or stage IV) non-small cell lung cancer (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.
Archival tumor tissue sample or newly obtained core, or excisional biopsy of a tumor lesion not previously irradiated has been provided.
Availability of programmed death-ligand 1 (PD-L1) biomarker result from central laboratory, using the Food and Drug Administration (FDA) approved Dako standardized diagnostic test (PD-L1 IHC 22C3 pharmDx).
Be ≥ 18 years of age on the day of signing the informed consent.
Participants capable of producing sperm must follow specific contraception guidelines during and after the trial intervention period.
A participant of childbearing potential (POCBP) is eligible if they are not pregnant, confirmed by a negative pregnancy test before the first trial dose.
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
Expected survival > 3 months.
Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (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 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 and have completed curative antiviral therapy at least 4 weeks prior to randomization.
Human immunodeficiency virus (HIV) infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease.
Adequate organ function.

: Is expected to require any other form of systemic or localized antineoplastic therapy (other than the trial treatment) while on trial.
Received prior radiotherapy within 2 weeks of start of trial intervention, or has radiation-related toxicities, requiring corticosteroids.
Participants whose tumor harbors any of the following actionable molecular alterations.
Epidermal growth factor receptor (EGFR)-sensitizing (activating) mutation
Anaplastic lymphoma kinase (ALK) gene fusion positive (ALK translocation)
c-ROS oncogene 1 (ROS1) translocation
For any indication has received any of the following therapies.
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, radiation therapy or had major surgery;
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;
within 6 months prior to cycle1 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.
Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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.
Evidence of severe or uncontrolled cardiac disease within 6 months prior to first dose of trial treatment.
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.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Concurrent active Hepatitis B and Hepatitis C virus infection.
HIV-infected patients 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 a live or live-attenuated vaccine within 30 days before the first dose of trial intervention.
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.

SponsorImmutep S.A.S.

Study typeInterventional

Conditions

Non-small cell lung carcinoma

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06726265