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

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Innate Pharma
Study ID
NCT05742607
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IPH5201 + durvalumab + standard chemotherapy — DRUG
    Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy. In Cohort 1 only, Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab.

Study Details

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

Key Dates

First listed
Feb 24, 2023
Start date
Jun 23, 2023
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IPH5201 + durvalumab + standard chemotherapy
    Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy. In Cohort 1 only, following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab.

Primary Outcome Measure

Pathological Complete Response (pCR) [ Time Frame: 16 weeks after the first dose of study intervention. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
St. Anthony's Hospital - BayCare Health SystemSt. PetersburgFlorida33705-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
University of Chicago Medical CenterChicagoIllinois60637-
Northwell Health Cancer Institute / Center for Novel Cancer TherapeuticsLake SuccessNew York11042-
Millennium Research & Clinical DevelopmentHoustonTexas77090-
UW Carbone Cancer Center - Cancer ConnectMadisonWisconsin53792-

Find similar trials in St. Petersburg, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
St. Anthony's Hospital - BayCare Health System· St. Petersburg, FLH. Lee Moffitt Cancer Center & Research Institute· Tampa, FLUniversity of Chicago Medical Center· Chicago, ILNorthwell Health Cancer Institute / Center for Novel Cancer Therapeutics· Lake Success, NYMillennium Research & Clinical Development· Houston, TXUW Carbone Cancer Center - Cancer Connect· Madison, WI

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