IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)
ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnate Pharma
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses - including collection of samples for genetic analysis, if applicable.
Patients must be ≥18 years at the time of screening.
Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC. Patients should have resectable disease (Stage IIA to Stage IIIA; Stage IIIB - Nodal stage N2 after the first 40 patients [cohort 2]), according to Version 8 of IASLC Staging Manual in Thoracic Oncology (2016), and be candidates for lobectomy, sleeve resection, or bilobectomy at the time of screening. For patients with N2 disease, only those with 1 single nodal station ≤3 cm are eligible (only valid for Cohort 1).
Disqualifiers
Patients with sensitizing EGFR mutations or ALK translocations.
History of allogeneic organ transplantation.
Patients with vitiligo or alopecia.
Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
Trial design
Design model
Single group
Treatments tested in this trial
IPH5201 + durvalumab + standard chemotherapy
DrugPatients 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: IPH5201 + durvalumab + standard chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathological Complete Response (pCR)
Number of patients with pathological Complete Response (pCR)
Time frame
16 weeks after the first dose of study intervention.2
Adverse events (AEs) and serious adverse events (SAEs)
Number of patients with adverse events (AEs) and serious adverse events (SAEs).
Time frame
Until Day 90 after the last dose of study interventions.Secondary outcomes
1
Event-Free Survival (EFS)
Number of patients experiencing an Event-Free Survival (EFS) event.
Time frame
Up to approximately 2 years.2
Disease Free Survival (DFS)
Number of patients experiencing a Disease Free Survival (DFS) event (event from surgery onwards).
Time frame
Up to approximately 2 years.3
Surgical resection
Number of participants having surgical resection.
Time frame
Approximately 16 weeks after the first dose of study intervention.4
Major Pathological Response (mPR)
Number of patients with a major Pathological Response (mPR).
Time frame
Approximately 16 weeks after the first dose of study intervention.Sponsors and contacts
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Source ClinicalTrials.gov