Treatment with IPH5201 and durvalumab in patients with Non-Small Cell Lung Cancer

Phase 1

• Conditions: on-Small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code 10029518Term: Non-small cell lung cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10029520Term: Non-small cell lung cancer stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-001903-42-HU
• Lead Sponsor: Innate Pharma SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
2.Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses – including collection of samples for genetic analysis, if applicable.
3.Patients must be = 18 years at the time of screening.
4.Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC. Patients should have resectable (Stage IIA to Stage IIIA) disease (according to Version 8 of IASLC Staging Manual in Thoracic Oncology 2016. For patients with N2 disease, only those with 1 single nodal station = 3 cm are eligible) and be candidate for lobectomy, sleeve resection, or bilobectomy at the time of screening.
5. WHO PS or ECOG PS of 0 or 1 at enrolment.
6. Adequate organ and marrow function as defined below:
• Haemoglobin = 9.0 g/dL.
• Absolute neutrophil count (ANC) = 1.5 × 109/L.
• Platelet count = 100 × 109/L.
• Serum bilirubin = 1.5 × Upper limit of normal (ULN). This will not apply to patients with
confirmed Gilbert’s syndrome, who will be allowed in consultation with their physician.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN.
• Measured creatinine clearance (CrCL) > 40 mL/min or calculated CrCL > 40 mL/min as
determined by Cockcroft-Gault formula using actual body weight (Cockroft and Gault, 1976)
(https://www.kidney.org/professionals/KDOQI/gfr_calculatorCoc).
7. Must have a life expectancy of at least 12 weeks.
8. Body Weight > 35 kg.
9. Male and/or female.
10. Negative pregnancy test (serum or urine) for women of
childbearing potential.
11. Provision of tumor samples (newly acquired [preferred] or archival tumor tissue [= 6 months old]) to confirm PD-L1 status, EGFR, or ALK status where required during screening and prior to nC1D1.
Provision of tumor samples appropriate for exploratory biomarker analyses.
13. Patients will be suitable for inclusion if the planned surgery to be performed will be lobectomy, sleeve
resection, or bilobectomy, as determined by the attending surgeon based on the baseline findings.
Patients whose planned surgery at enrolment includes pneumonectomy, segmentectomies, or
wedge resections are not eligible for this study.
14. A pre- or post-bronchodilator FEV1 of 1.0 L and DLCO > 40% postoperative predicted value. Use of these cut-off values to assess candidacy for resection should be guided by the results of
cardiopulmonary exercise testing as outlined in the ESMO guidelines on pre-treatment risk assessment. Both an FEV1 and a DLCO test are required for assessing lung function at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1.Patients with sensitizing EGFR mutations or ALK translocations.
2.History of allogeneic organ transplantation.
3.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic
lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [e.g., granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, or uveitis]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia.
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone
replacement.
• Any chronic skin condition that does not require systemic therapy.
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• Patients without active disease in the last 5 years may be included but only after consultation
with the Study Physician/Medical Scientist.
• Patients with celiac disease controlled by diet alone.
4. Uncontrolled intercurrent illness, including but not limited to, uncontrolled hypertension, unstable
angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious
chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or
compromise the ability of the patient to give written informed consent.
5. History of any grade of venous or arterial thromboembolic events including cerebrovascular accident, transient ischemic attack, or unstable angina pectoris within 6 months prior to enrollment.
6. History of another primary malignancy, except for the following:
• Malignancy treated with curative intent and with no known active disease =5 years before the first dose of study drugs and of low potential risk for recurrence.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Adequately treated carcinoma in-situ without evidence of disease.
6. Patients with small-cell lung cancer or mixed small-cell lung cancer.
7. History of active primary immunodeficiency.
8. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis
B (known positive HBsAg result) and HCV. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible. Patients positive
for HCV antibody are eligible only if PCR is negative for HCV RNA.
9. Patients who have preoperative radiotherapy treatment as part of their care plan.
10. Patients who require or may require pneumonectomy, segmentectomies, or wedge resections, as
assessed by their surgeon, to obtain potentially curative resection of primary tumor.
11. QTc interval = 470 ms (NOTE: If prolonged, then 2 additional ECGs should be obtained and the average QTcF interval should be used to determine eligibility).
12. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
13. Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
14. Patients with moderate or severe cardiovascular disease:
• Presence of cardiac disease, including myocardial infarction or unstable angina pectoris within
6 months prior to study entry.
• NYHA Class 3 or 4 congestive heart failure, or uncontrolled hyperte

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified