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1st Line Durvalumab in PS 2 NSCLC Patients | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

1st Line Durvalumab in PS 2 NSCLC Patients

First Line Durvalumab in Patients With PD-L1 Positive, Advanced NSCLC With Performance Status 2 Unsuitable for Combination Chemotherapy. A Multicenter, Single-arm Phase II Trial

NCT03620669•Swiss Cancer Institute

View on ClinicalTrials.gov

Summary

The aim of the trial is to assess efficacy and safety of the treatment with durvalumab in PS 2 patients with treatment-naïve, locally advanced or metastatic, PD-L1 positive NSCLC who are considered unsuitable for combination platinum-containing therapy.

Detailed Description

Lung cancer is the leading cause of cancer deaths. An estimated 30 to 40% of patients diagnosed with NSCLC have a poor Performance status (PS) defined as a score of 2 or higher on the ECOG scale. PS 2 patients are often underrepresented in clinical trials despite representing a very frequent and important subgroup. Platinum-based (preferably carboplatin) doublets should be considered as standard of care in eligible PS 2 patients. However the toxicity profile of platinum-based doublets remains a concern. Single-agent chemotherapy represents an alternative treatment option for the PS 2 patients considered unsuitable for platinum doublet chemotherapy but its efficacy is limited and the outcome poor. Given the superiority of the anti-PD-1 antibody pembrolizumab versus standard chemotherapy as first line therapy in a PD-L1 positive NSCLC population, it now became the standard treatment. The PS of patients enrolled in these trials were PS 0 or 1, making the benefit of PD-L1 antibodies in PS 2 patients unclear. A retrospective real-life data analysis of nivolumab in metastatic NSCLC revealed similar treatment-related AE between patients with a PS of 0 or 1 with those having a PS of 2, confirming good treatment tolerability in poor PS patients. The overall favorable toxicity profile of durvalumab and the absence of robust efficacy data of checkpoint inhibitors in first line treatment of patients with PD-L1 positive NSCLC with a PS of 2, encourage to investigate its activity in this cohort of patients when considered unsuitable for platinum doublet chemotherapy. Finally, this trial aims to prolong overall survival by treating this cohort of frail patients with durvalumab, compared to historical controls, treated with single agent chemotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent according to Swiss law and ICH/GCP regulations before registration and prior to any trial specific procedures
•Histologically confirmed NSCLC, advanced or recurrent disease (stage IIIB to IV). Cytology could be accepted if histology is not possible
•PD-L1 expression of ≥ 25% of the tumor cells by local testing (Ventana SP142 excluded)
•No sensitizing EGFR mutation (L858R or exon 19 deletions), ALK fusion oncogene or rearrangements of the ROS1 gene detected in patients with a non-squamous cell NSCLC
•Patient unsuitable for platinum-containing combination chemotherapy according to investigator or due to patient preference
•WHO PS of 2. Confirmation of PS2 by a second medical doctor is mandatory.
•Age ≥ 18 years
•Baseline QoL forms and GA questionnaires have been completed
•Bone marrow function: hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L
•Hepatic function: bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN); patients without liver metastases: AST and ALT ≤ 2.5 x ULN, patients with documented liver metastases: AST and ALT ≤ 5 x ULN
+16 more criteria

Exclusion Criteria

•Any potential patient who meets any of the following criteria has to be excluded from entering the trial.
•History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years before registration with the exception of pT1-2 prostate cancer Gleason score \<6, adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
•Prior adjuvant systemic anti-cancer treatment within 6 months before registration
•Prior systemic treatment for metastatic NSCLC
•Prior treatment with a PD-1 or PD-L1 inhibitor
•Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e. which must not exceed 10 mg/day of prednisone or an equivalent corticosteroid)
•Concomitant drugs contraindicated for use with durvalumab such as corticosteroids, methotrexate, azathioprine and tumor necrosis factor (TNF)-α blockers
•Concurrent treatment with other experimental drugs or other anticancer therapy, treatment in a clinical trial within 28 days prior to registration
•Major surgical procedure within 14 days prior to registration
•Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
+17 more criteria

Locations (11)

Kantonsspital Aarau

Aarau, Switzerland

Kantonsspital Baden

Baden, Switzerland

Universitaetsspital Basel

Basel, Switzerland

IOSI Ospedale Regionale di Bellinzona e Valli

Bellinzona, Switzerland

Inselspital

Bern, Switzerland

Kantonsspital Graubuenden

Chur, Switzerland

Hopital Fribourgeois HFR

Fribourg, Switzerland

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, Switzerland

Spital STS AG

Thun, Switzerland

Key Dates

Start Date

December 4, 2018

Primary Completion Date

January 19, 2023

Completion Date

September 30, 2027

Last Updated

August 15, 2025

Enrollment

ACTUAL participants

Conditions

NSCLC Stage IVNSCLC Stage IIIB

Interventions

Durvalumab

DRUG

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

NCT06219317

NSCLC Stage IV

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RECRUITINGPHASE2

A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

NCT06947694

NSCLC Stage IV Without EGFR/ALK Mutation

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RECRUITINGPHASE2

Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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1st Line Durvalumab in PS 2 NSCLC Patients

Inclusion Criteria

Exclusion Criteria

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

Phase 2 Study of Dacomitinib in NSCLC

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