Study on IPH5201 and Durvalumab for Patients with Resectable Non-Small Cell Lung Cancer (MATISSE)

Sponsor: Innate Pharma

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05742607

Provider View

This clinical trial is testing a new treatment combination of IPH5201 and durvalumab, along with standard chemotherapy, to see if it is safe and effective for patients with early-stage non-small cell lung cancer that can be surgically removed.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment approach for patients with early-stage non-small cell lung cancer (NSCLC) that can be surgically removed. The treatment involves using a combination of two drugs, IPH5201 and durvalumab, along with standard chemotherapy before surgery, and continuing with IPH5201 and durvalumab after surgery.

Description

This study is open-label, meaning both the researchers and participants know what treatment is being given. It is a single-arm study conducted at multiple centers. Eligible patients will receive a combination of IPH5201, durvalumab, and standard chemotherapy before undergoing surgery to remove the cancer. After surgery, patients will continue to receive IPH5201 and durvalumab to help prevent the cancer from returning.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed and previously untreated patients with non-small cell lung cancer (NSCLC) that can be surgically removed (Stage IIA to IIIA).
  • Good overall health with a performance status score of 0 or 1.
  • Adequate organ and bone marrow function.
  • Life expectancy of at least 12 weeks.
  • Body weight over 35 kg.
  • Women of childbearing potential must use effective contraception during the study.
  • Negative pregnancy test for women of childbearing potential.
  • Provide tumor samples to confirm specific cancer markers and for research purposes.
  • Surgery planned should be lobectomy, sleeve resection, or bilobectomy.
  • Lung function tests showing FEV1 of 1.0 L and DLCO over 40% predicted value.

Exclusion Criteria

  • Specific genetic mutations in the cancer (EGFR or ALK).
  • History of organ transplantation.
  • Autoimmune or inflammatory disorders.
  • Uncontrolled health conditions like high blood pressure or heart problems.
  • Recent history of blood clots or strokes.
  • History of another type of cancer.
  • Small-cell lung cancer or mixed types.
  • Primary immune system deficiencies.
  • Active infections like tuberculosis, hepatitis B, or hepatitis C.
  • Previous radiotherapy before surgery.
  • Need for certain types of lung surgery not allowed in the study.
  • Heart rhythm issues (QTc interval ≥ 470 ms).
  • Allergies to study drugs.
  • Medical reasons preventing chemotherapy.
  • Moderate or severe heart disease.
  • Other cancer treatments or investigational drugs recently used.
  • Recent major surgery.
  • Previous exposure to similar immune therapies.
  • Use of immunosuppressive drugs recently.
  • Participation in another clinical trial recently.
  • Previous assignment to study drugs in this trial.
  • Pregnant or breastfeeding women, or those not using birth control.
  • Involvement in the study planning or conduct.
  • Investigator's judgment that the patient cannot comply with the study.

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