H1-antihistaminE treatment in combiNation with immunotHerapy in pAtieNts with advanced non small cell lung canCEr: A single- center phase -ENHANCE

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

13 Oct 2022 → ongoing

Decision date (initial)

2024-12-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-518633-28-00

EudraCT number

2022-001284-27

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

Best objective response rate according to RECIST 1.1

Conditions and MedDRA coding

Advanced non small lung cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Capability of understanding the purpose of the study and have given written informed consent. • Histologically confirmed squamous or non-squamous NSCLC • Radiologically documented metastatic unresectable disease • Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) • No previous systemic therapy for metastatic disease • Patients who are planned to receive pembrolizumab monotherapy in routine indication and according to the marketing authorisation • Patient with a history of adequately treated, asymptomatic CNS metastases are eligible, provided they meet all of the following criteria: Only supratentorial metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord). No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed. • Age ≥ 18 years • ECOG-PS 0-2, KPS >70% • Adequate bone-marrow, liver and kidney function – except of a tumor-associated dysfunction due to metastatic NSCLC disease • No previous systemic therapy for metastatic disease. Patients who received prior radio- and/or chemotherapy in neoadjuvant or adjuvant indications before study inclusion are allowed in consideration of an adequate washout period before the enrolment. Adequate treatment washout period before enrolment, defined as: - Major Surgery: ≥4 weeks - Radiation therapy: ≥4 weeks - Chemotherapy: ≥2 weeks - Systemic steroid-treatment: ≥2 weeks • Patient must be able to tolerate therapy • Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days before first administration of IMP. Approved methods of birth control must be used in women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, from study start to the last dose of protocol therapy. Adequate contraception defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.

Exclusion criteria 1

1. • Patients who received anti-CTLA4, or therapies targeting the PD-L1 and PD-1 pathway for early-stage NSCLC • A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs • Patients requiring concomitant use of chronic systemic (IV or oral) corticosteroids higher than 10mg prednisolone per day or other immunosuppressive medications except for managing adverse events (inhaled steroids or intra articular steroid injections are permitted in this study) • Use of any investigational agent within 28 days prior to initiation of study treatment • History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years • Presence of history of drug hypersensitivity of fexofenadine hydrochloride or other related products • Known autoimmune disease (with the exception of residual hypothyroidism on an autoimmune basis, diabetes mellitus type 1, psoriasis not requiring systemic treatment) • Known HIV • Hepatitis B or C infection • Pregnant or lactating women • Male subjects unable or unwilling to use adequate contraception methods • Patients with known substance abuse or any other medical conditions such as clinically significant neurological or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results • Patients who are unable to swallow

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response rate according to RECIST 1.1., ORR; defined as complete or partial response at any timepoint during study period.

Secondary endpoints 1

1. Secondary Endpoint: Progression-free survival (PFS), Overall survival (OS). Exploratory Endpoint: Safety & tolerability of fexofenadine in terms of haematologic and nonhaematologic side effects as assessed by the investigators. Quality of life (QoL) with focus on sleeping behavior in patients receiving fexofenadine assessed by the Pittsburgh Sleep Quality Index (PSQI), EORTC QLQ-c30 questionnaire and Lung Cancer Symptom Scale (LCSS). Analysis of predictive factors for the enhancement of immunoth

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Medicine I, Division of Oncology

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Medicine I, Division of Oncology

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications