Clinical Trial 22380

• Overview

  Study 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)

  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).

  Objective:

  Primary: 1. To assess the antitumor activity of neoadjuvant treatment administered prior to surgery in terms of pathological complete response (pCR). 2. To assess the safety and tolerability of neoadjuvant and adjuvant treatment. Secondary: 1. To assess the efficacy of neoadjuvant treatment administered prior to surgery followed by adjuvant treatment post-surgery in terms of Event Free Survival (EFS). 2. To access to efficacy of neoadjuvant treatment administered prior to surgery followed by adjuvant treatment post-surgery in terms of Disease Free Survival (DFS) (event from surgery onwards).

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy

  Medications:

  AMP-514 (Durvalumab); Alimta (Pemetrexed); Durvalumab (); MEDI4736 (Durvalumab); Paraplatin (carboplatin); Pemetrexed (); Taxol (paclitaxel); carboplatin (); cisplatin (); paclitaxel ()

• Inclusion 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.
  • World Health Organization (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

  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 or more (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 enrollment.
  • 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.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.