Treatment with IPH5201 and durvalumab in patients with Non-Small Cell Lung Cancer
- Conditions
- on-Small Cell Lung Cancer II, III, IIIAMedDRA version: 21.1Level: PTClassification code: 10029519Term: Non-small cell lung cancer stage III Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10029518Term: Non-small cell lung cancer stage II Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10029520Term: Non-small cell lung cancer stage IIIA Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507778-42-00
- Lead Sponsor
- Innate Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
1. Informed consent: 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., 10. Sex: Negative pregnancy test (serum or urine) for women of childbearing potential., 11 Tumor sample requirements: 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., 12. Tumor sample requirements: Provision of tumor samples appropriate for exploratory biomarker analyses, 13. Surgery eligibility (assessments performed at screening): 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. Surgery eligibility (assessments performed at screening): 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., 2. Informed consent: 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. Age: Patients must be = 18 years at the time of screening., 4. Type of Participant and Disease Characteristics : 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. Type of Participant and Disease Characteristics: WHO PS or ECOG PS of 0 or 1 at enrolment, 6. Type of Participant and Disease Characteristics: 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., 7. Type of Participant and Disease Characteristics: Must have a life expectancy of at least 12 weeks., 8. Weight: Body Weight > 35 kg., 9. Sex: Male and/or female.
1. Medical Conditions: Patients with sensitizing EGFR mutations or ALK translocations., 10. Medical Conditions: 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. Medical Conditions: 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. Medical Conditions: Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients., 13. Medical Conditions: Any medical contraindication to treatment with chemotherapy as listed in the local labelling., 14. Medical Conditions: 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 hypertension. • History of hypertensive crisis/hypertensive encephalopathy within the past 6 months prior to the scheduled first dose of study treatment, 15. Prior/Concomitant Therapy: Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable., 16. Prior/Concomitant Therapy: Receipt of live attenuated vaccine within 30 days prior to the first dose of study drugs. Note: Patients, if enrolled, should not receive live vaccine while receiving study drugs and up to 30 days after the last dose of study drugs., 17. Prior/Concomitant Therapy: Major surgical procedure (as defined by the Investigator) within 30 days prior to the first dose of study drugs., 18. Prior/Concomitant Therapy: Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Patients who received agents targeting the adenosine pathway (e.g., anti-CD73, A2AR inhibitors, anti-CD39) are also excluded., 19. Prior/Concomitant Therapy: Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs. The following are exceptions to this criterion: • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection). • Systemic corticosteroids = 12 mg/day of prednisone or its equivalent. • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)., 2. Medical Conditions: History of allogeneic organ transplantation., 20. Prior/concurrent clinical study experience: Participation in another clinical study with an investigational product administered within 30 days prior to enrolment., 21. Prior/concurrent clinical study experience: Previous study drugs (durvalumab, IPH5201) assignment in the present study., 22. Other Exclusions: Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of study drugs administration., 23. Other Exclusions: Involvement in the planning and/or conduct of the study (applies to company staff and/or staff at the study site)., 24. Other Exclusions: Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method