IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)

• Status: Recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innate Pharma
• Treatments: Antibodies, Monoclonal; Carboplatin; Cisplatin; Durvalumab; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

1. 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.

2. WHO Performance Status or Eastern Cooperative Oncology Group of 0 or 1.

3. Adequate organ and marrow function.

4. Provision of tumor samples (newly acquired [preferred] or archival tumor tissue [≤ 6 months old]) to confirm Programmed Death-Ligand 1 status, Estimated Glomerular Filtration Rate, or Anaplastic Lymphoma Kinase status.

5. Adequate pulmonary function

Exclusion Criteria:

1. Participants with sensitising EGFR mutations or ALK translocations.

2. History of allogeneic organ transplantation.

3. Active or prior documented autoimmune or inflammatory disorders.

4. 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.

5. History of another primary malignancy.

6. Participants with sensitising EGFR mutations or ALK translocations.

7. History of allogeneic organ transplantation.

8. Active or prior documented autoimmune or inflammatory disorders.

9. 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.

10. History of another primary malignancy.

11. Participants with small-cell lung cancer or mixed small-cell lung cancer.

12. History of active primary immunodeficiency.

13. Participants who have preoperative radiotherapy treatment as part of their care plan.

14. Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.

15. QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.

16. Any medical contraindication to treatment with chemotherapy as listed in the local labelling.

17. Participants with moderate or severe cardiovascular disease.

18. Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.

19. Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.

20. Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A and HLA-E agents are also excluded.

21. Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.

22. Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions

23. Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A and HLA-E agents are also excluded.

24. Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.