1st Line Durvalumab in PS 2 NSCLC Patients

NCT03620669 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: SAKK 19/17
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

NSCLC Stage IV; NSCLC Stage IIIB

Keywords

Lung cancer; Durvalumab; PD-L1; NSCLC; Phase II; PS 2

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS) at 6 months

  OS at 6 months is defined as being alive at 6 months after registration.

  At 6 months after registration

Secondary Outcomes (12)

• Objective response (OR) according to RECIST 1.1

  At trial treatment discontinuation or the latest 5 years after last patient discontinued trial treatment

• Objective response according to iRECIST (iOR)

  At trial treatment discontinuation or the latest 5 years after last patient discontinued trial treatment

• Duration of response (DoR) according to RECIST 1.1

  At disease progression according to RECIST 1.1 criteria or death due to disease progression or the latest 5 years after last patient discontinued trial treatment

• Duration of response according to iRECIST (iDoR)

  At disease progression according to iRECIST criteria (iPD) or death due to disease progression or the latest 5 years after last patient discontinued trial treatment

• Progression-free survival (PFS) according to RECIST 1.1

  At disease progression according to RECIST v1.1 criteria or death due to any cause or the latest 5 years after last patient discontinued trial treatment

Study Arms (1)

Durvalumab

EXPERIMENTAL

Durvalumab until progression or unacceptable toxicity

Drug: Durvalumab

Interventions

Durvalumab DRUG

Durvalumab 1500mg q4W until progression or unacceptable toxicity

Also known as: MEDI4736

Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Renal function: estimated glomerular filtration rate (eGFR)\> 30 mL/min/1.73m² (according to CKD-EPI formula)
• Measurable or evaluable disease (by RECIST v1.1)
• Patients with asymptomatic untreated CNS metastases are eligible, provided they meet the following:
• ≤ 5 CNS lesions with a maximum diameter of one lesion of 10 mm
• Only supratentorial metastases allowed (i.e., no metastases to midbrain, pons, cerebellum, medulla, or spinal cord)

You may not qualify if:

• 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:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Patients without active disease in the last 5 years may be included but only after consultation with the coordinating investigator
• Patients with celiac disease controlled by diet alone

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (11)

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Universitaetsspital Basel

Basel, 4031, Switzerland

Location

IOSI Ospedale Regionale di Bellinzona e Valli

Bellinzona, 6500, Switzerland

Location

Inselspital

Bern, 3010, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Hopital Fribourgeois HFR

Fribourg, 1708, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Spital STS AG

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8401, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Mark, MD

  Kantonsspital Graubünden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-arm open-label multicenter phase II trial

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 8, 2018
• Study Start: December 4, 2018
• Primary Completion: January 19, 2023
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CH (11)