CompletedPhase 2

SAKK 17/18 (ORIGIN) MPM & NSCLC >1st Line Gemci & Atezo Ph II

Switzerland68 participantsStarted 2021-03-17

Plain-language summary

A significant number of patients with malignant pleural mesothelioma (MPM) and non-small cell lung cancer (NSCLC) are not cured with available treatments and will eventually relapse. After relapse treatment options are limited. Preclinical in vitro studies have demonstrated a synergism of immunotherapy with PD(L)1-targeting monoclonal antibodies and gemcitabine and ongoing clinical studies showed encouraging results. The main objective of this trial is to determine the efficacy of chemotherapy (gemcitabine) combined with immunotherapy (atezolizumab) in patients with progressive NSCLC and MPM. The trial treatments will be continued for max. 2 years or until discontinuation criteria are met. The follow-up phase will last up to 5 years from treatment start.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent according to Swiss law and ICH/GCP regulations before registration and prior to any trial specific procedures including screening procedures. * For Cohort 1 (NSCLC): Patients with histologically- or cytologically- confirmed squamous or non-squamous metastatic NSCLC stage IIIB-IV (based on TNM classification). Patients must have experienced disease recurrence or progression during or after one or more prior immunotherapy or chemo-immunotherapy regimen for metastatic disease. * For Cohort 2 (MPM): Patients with histologically confirmed inoperable malignant pleural mesothelioma (MPM; with or without metastasis; all histological subtypes are eligible). Participants must have experienced disease recurrence or progression during or after one or more prior systemic therapy regimen for advanced or metastatic disease. * Patients with treated and stable CNS metastases are eligible, if: * Previous CNS-directed therapy has been completed at least 4 weeks prior to treatment start * No evidence of progression after completion of CNS-directed therapy as ascertained by clinical examination and brain imaging (MRI or CT). * Patients with known HIV-infection are eligible, if: * CD4+ T-cell counts are ≥ 350 cells/ųl * No history of AIDS-defining opportunistic infection within past 12 months * Patient agrees to concomitant antiretroviral therapy (ART) if not currently on ART, or is on ART for ˃ 4 weeks and has a HIV viral load ˂ 400 copi…

What they're measuring

Primary endpoint for cohort 1: Objective response rate (ORR) according to RECIST 1.1

Timeframe: At the date of tumor assessment according to RECIST 1.1, assessed up to 2 years after registration

Primary endpoint for cohort 2: ORR according to mRECIST

Timeframe: At the date of tumor assessment according to mRECIST, assessed up to 2 years after registration

Trial details

NCT IDNCT04480372

SponsorSwiss Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-10

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