E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Best objective response rate according to RECIST 1.1 |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 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.
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E.4 | Principal exclusion criteria |
• 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective response rate according to RECIST 1.1., ORR; defined as complete or partial response at any timepoint during study period. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary Endpoint: Progression-free survival (PFS), Overall survival (OS)
Exploratory Endpoint: Safety & tolerability of fexofenadine in terms of haematologic and non- haematologic 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 immunotherapy by fexofenadine in blood (such as histamine concentration) and tumor tissue (infiltration of tumor infiltrating lymphocytes; HRH1 expression) if available
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after every 3rd cycle of immunotherapy |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |