IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05742607 |
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Recruitment Status :
Recruiting
First Posted : February 24, 2023
Last Update Posted : March 15, 2024
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Sponsor:
Innate Pharma
Information provided by (Responsible Party):
Innate Pharma
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Brief Summary:
The study is intended to assess the safety and efficacy of neoadjuvant combination of IPH5201 and durvalumab in addition to standard chemotherapy and adjuvant combination of IPH5201 and durvalumab in untreated patients with resectable, early-stage (stage II to IIIA) non-small cell lung cancer (NSCLC).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Small Cell Lung Cancer | Drug: IPH5201 + durvalumab + standard chemotherapy | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 70 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Masking Description: | Experimental: IPH5201 + durvalumab + chemotherapy Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy. Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab |
| Primary Purpose: | Treatment |
| Official Title: | Official Title: A Phase II Multicenter, Open Label, Non-randomized Study of Neoadjuvant and Adjuvant Treatment With IPH5201 and Durvalumab in Patients With Resectable, Early-stage (II to IIIA) Non-Small Cell Lung Cancer (MATISSE) |
| Actual Study Start Date : | June 23, 2023 |
| Estimated Primary Completion Date : | June 2025 |
| Estimated Study Completion Date : | September 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information
available for:
Durvalumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: IPH5201 + durvalumab + standard chemotherapy
Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy. Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab. |
Drug: IPH5201 + durvalumab + standard chemotherapy
Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy. Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab. Other Names:
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Primary Outcome Measures :
- Pathological Complete Response (pCR) [ Time Frame: 16 weeks after the first dose of study intervention. ]Number of patients with pathological Complete Response (pCR)
- Adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Until Day 90 after the last dose of study interventions. ]Number of patients with adverse events (AEs) and serious adverse events (SAEs).
Secondary Outcome Measures :
- Event-Free Survival (EFS) [ Time Frame: Up to approximately 2 years. ]Number of patients experiencing an Event-Free Survival (EFS) event.
- Disease Free Survival (DFS) [ Time Frame: Up to approximately 2 years. ]Number of patients experiencing a Disease Free Survival (DFS) event (event from surgery onwards).
- Surgical resection [ Time Frame: Approximately 16 weeks after the first dose of study intervention. ]Number of participants having surgical resection.
- Major Pathological Response (mPR) [ Time Frame: Approximately 16 weeks after the first dose of study intervention. ]Number of patients with a major Pathological Response (mPR).
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 4 months adjuvant. ]Number of patients with an Objective Response Rate (ORR).
- Overall Survival (OS) [ Time Frame: Up to approximately 2 years. ]Overall Survival (OS).
- PK of IPH5201 in combination with durvalumab +/- chemotherapy [ Time Frame: Up to approximately 4 months adjuvant. ]Serum concentration (PK) of IPH5201 in combination with durvalumab +/- chemotherapy, in patients receiving neoadjuvant and adjuvant treatment.
- Anti-study drug antibodies (ADA) [ Time Frame: Up to approximately 4 months adjuvant. ]Number of patients with anti-study drug antibodies (ADA).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC resectable (Stage IIA to Stage IIIA) disease (according to Version 8 of IASLC Staging Manual in Thoracic Oncology 2016.
- WHO Performance Status or Eastern Cooperative Oncology Group of 0 or 1.
- Adequate organ and marrow function.
- Must have a life expectancy of at least 12 weeks.
- Body weight > 35 kg.
- Females of childbearing potential should use an acceptable method of contraception from the time of screening throughout the total duration of the study.
- Negative pregnancy test (serum or urine) for women of childbearing potential.
- Provision of tumor samples (newly acquired [preferred] or archival tumor tissue [≤ 6 months old]) to confirm Programmed Death-Ligand 1 status, Epidermal Growth Factor Receptor, or Anaplastic Lymphoma Kinase status.
- Provision of tumor samples appropriate for exploratory biomarker analyses.
- 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.
- A pre- or post-bronchodilator FEV1 of 1.0 L and DLCO > 40% postoperative predicted value.
Exclusion Criteria:
- Participants with sensitising EGFR mutations or ALK translocations.
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.
- 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.
- History of another primary malignancy.
- Patients with small-cell lung cancer or mixed small-cell lung cancer.
- History of active primary immunodeficiency.
- 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.
- Patients who have preoperative radiotherapy treatment as part of their care plan.
- Patients who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon, to obtain potentially curative resection of primary tumor.
- 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).
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
- Patients with moderate or severe cardiovascular disease.
- 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.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
- Major surgical procedure (as defined by the Investigator) within 30 days prior to the first dose of study drugs.
- Prior exposure to immune-mediated therapy.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs.
- Participation in another clinical study with an investigational product administered within 30 days prior to enrolment.
- Previous study drugs (durvalumab, IPH5201) assignment in the present study.
- 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.
- Involvement in the planning and/or conduct of the study (applies to both company staff and/or staff at the study site).
- 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 requirements.
- Exclusion criteria for participation in the optional (DNA) genetics research component.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05742607
Contacts
| Contact: Innate Pharma | +33484903084 | clinical.trials@innate-pharma.fr |
Locations
Show 30 study locations
Sponsors and Collaborators
Innate Pharma
| Responsible Party: | Innate Pharma |
| ClinicalTrials.gov Identifier: | NCT05742607 |
| Other Study ID Numbers: |
IPH5201-201 |
| First Posted: | February 24, 2023 Key Record Dates |
| Last Update Posted: | March 15, 2024 |
| Last Verified: | March 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Cisplatin Carboplatin Pemetrexed |
Durvalumab Antibodies, Monoclonal Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Immunological Immunologic Factors Physiological Effects of Drugs |