OncoMatch/Clinical Trials/NCT05742607
IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)
Is NCT05742607 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies IPH5201 + durvalumab + standard chemotherapy for non small cell lung cancer.
Treatment: IPH5201 + durvalumab + standard chemotherapy — In Cohort 1, the study was intended to assess 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). Study Design was updated following the results of interim analysis # 2 (protocol amendment, adding cohort 2). Cohort 2 includes patients with resectable Stage II to IIIB NSCLC expressing PD-L1 ≥1%, receiving (only) neoadjuvant IPH5201+ durvalumab + chemotherapy
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
Provision of tumor samples ... to confirm PD-L1 status ... PD-L1 testing using the Ventana PD-L1 (SP263) IHC assay will be performed centrally ... For Cohort 2 (PD-L1-positive cohort), only patients with PD-L1 expression tumor proportion score (TPS) ≥1% will be enrolled.
Excluded: EGFR sensitizing mutation
Patients with sensitizing EGFR mutations ... [excluded]
Excluded: ALK fusion
Patients with ... ALK translocations [excluded]
Excluded: PD-L1 (CD274) expression
Only for patients in Cohort 2: Patients with PD-L1 expression TPS <1% or unknown PD-L1 status [excluded]
Disease stage
Required: Stage IIA, IIB, IIIA, IIIB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immune-mediated therapy (anti-CTLA-4 antibody, anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD73 antibody, adenosine A2A receptor inhibitor, anti-CD39 antibody)
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 antibody, adenosine A2A receptor [A2AR] inhibitor, anti-CD39 antibody) are also excluded.
Cannot have received: preoperative radiotherapy
Patients who have preoperative radiotherapy treatment as part of their care plan [excluded]
Cannot have received: concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment
Exception: concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
Any concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment. However, concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; ANC ≥1.5 × 10^9/L; Platelet count ≥100 × 10^9/L
Kidney function
Measured or calculated creatinine clearance >40 mL/min
Liver function
Serum bilirubin ≤1.5 × ULN (except Gilbert's syndrome); ALT and AST ≤2.5 × ULN
Cardiac function
QTc interval <470 ms; no NYHA Class III/IV CHF; no uncontrolled hypertension; no history of hypertensive crisis/encephalopathy within 6 months; no myocardial infarction or unstable angina within 6 months
Adequate organ and marrow function as defined below: Hemoglobin ≥9.0 g/dL; ANC ≥1.5 × 10^9/L; Platelet count ≥100 × 10^9/L; Serum bilirubin ≤1.5 × ULN (except Gilbert's syndrome); ALT and AST ≤2.5 × ULN; Measured or calculated creatinine clearance >40 mL/min. QTc interval <470 ms; no NYHA Class III/IV CHF; no uncontrolled hypertension; no history of hypertensive crisis/encephalopathy within 6 months; no myocardial infarction or unstable angina within 6 months.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Anthony's Hospital - BayCare Health System · St. Petersburg, Florida
- H. Lee Moffitt Cancer Center & Research Institute · Tampa, Florida
- University of Chicago Medical Center · Chicago, Illinois
- Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics · Lake Success, New York
- Millennium Research & Clinical Development · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05742607 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune-mediated therapy, preoperative radiotherapy, concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR sensitizing mutation is an exclusion criterion.
Are patients with ALK alterations eligible?
No. ALK fusion is an exclusion criterion.
What disease stage is eligible?
Stage IIA or IIB or IIIA or IIIB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify