NSCLC Stage IVPhase 2NCT03620669
1st Line Durvalumab in PS 2 NSCLC Patients
A Phase 2 study testing Durvalumab in people with NSCLC Stage IV and NSCLC Stage IIIB, run by Swiss Cancer Institute at 11 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV, NSCLC Stage IIIB
- What is being tested?
- Durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 11 sitesSwitzerland
- Study dates
- 4 Dec 2018to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
- No evidence of progression at registration compared to the latest brain imaging
- No ongoing requirement for corticosteroids as therapy for CNS disease
- Patients with symptomatic treated CNS metastases are eligible, provided they meet the following:
- No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed
- No stereotactic radiation or whole-brain radiation within 7 days prior to registration
- No evidence of progression at registration, after completion of CNS-directed therapy
- Tumor tissue available for central PD-L1 assessment and translational research (preferably histology but cytology could be allowed if histology is not possible). In case of scarce tumor material, a rebiopsy, if clinically possible, is encouraged
- Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and during the 3 months thereafter. A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential
- Men agree not to father a child during trial treatment and during 3 months thereafter
- Body weight > 30kg.
- Life expectancy > 3 months.
Who cannot join
- 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)
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- 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
- Uncontrolled diabetes mellitus
- Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment
- Known history of tuberculosis
- Known history of primary immunodeficiency
- Known history of allogeneic organ transplant
- Receipt of live attenuated vaccine within 28 days prior to registration
- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV; unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
- Patients with dyspnea grade ≥ 3 according to the modified Medical Research Council (mMRC) dyspnea scale.
- Patients with symptomatic pneumonitis (grade ≥ 2) or active lung infection. Patients having fully recovered from active lung infection can be included assumed they have completed antibiotics and/or corticosteroids
- Patients with disseminated intravascular coagulopathy
- Patient with a baseline CT scan older than 21 days prior to registration.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Switzerland11 sites
Kantonsspital Aarau
Aarau, CH-5001
Kantonsspital Baden
Baden, 5404
Universitaetsspital Basel
Basel, 4031
IOSI Ospedale Regionale di Bellinzona e Valli
Bellinzona, 6500
Inselspital
Bern, 3010
Kantonsspital Graubuenden
Chur, CH-7000
Hopital Fribourgeois HFR
Fribourg, 1708
Hôpitaux Universitaires de Genève
Geneva, 1211
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007
Spital STS AG
Thun, 3600
Kantonsspital Winterthur
Winterthur, CH-8401
About this study
Official title: 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
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.
Read the 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.
- Conditions
- NSCLC Stage IV, NSCLC Stage IIIB
- Being tested
- Durvalumab
- Keywords
- Lung cancer, Durvalumab, PD-L1, NSCLC, Phase II, PS 2
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
Durvalumab 1500mg q4W until progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab | Experimental | Durvalumab until progression or unacceptable toxicity Receives: Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) at 6 months
OS at 6 months is defined as being alive at 6 months after registration.
Measured: At 6 months after registration
Secondary outcomes (12)
Objective response (OR) according to RECIST 1.1
OR is defined as any complete response (CR) or partial response (PR) according to RECIST 1.1 criteria achieved during trial treatment.
Measured: At trial treatment discontinuation or the latest 5 years after last patient discontinued trial treatment
Objective response according to iRECIST (iOR)
iOR is defined as any complete response (CR/iCR) or partial response (PR/iPR) according to RECIST1.1 or iRECIST criteria achieved during trial treatment.
Measured: At trial treatment discontinuation or the latest 5 years after last patient discontinued trial treatment
Duration of response (DoR) according to RECIST 1.1
DoR is defined as the time from the first documentation of OR until disease progression according to RECIST 1.1 criteria or death due to disease progression, whichever occurs first.
Measured: 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)
iDoR is defined as the time from the first documentation of iOR until disease progression according to iRECIST criteria (iPD) or death due to disease progression.
Measured: 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
PFS is defined as the time from registration until disease progression according to RECIST v1.1 criteria or death due to any cause, whichever occurs first.
Measured: 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
Progression-free survival according to iRECIST (iPFS)
iPFS is defined as the time from registration until disease progression according to iRECIST criteria (iPD) or death due to any reason, whichever occurs first.
iPD is defined as the time point of first iUPD without subsequent iSD, iPR or iCR before trial treatment discontinuation.
Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment showing no evidence of iPD before starting a subsequent anticancer treatment, if any.
Measured: At disease progression according to iRECIST criteria (iPD) or death due to any reason or the latest 5 years after last patient discontinued trial treatment
Overall survival (OS)
OS is defined as the time from registration until death due to any cause
Measured: At death of the patient or the latest 5 years after last patient discontinued trial treatment
Adverse events (AEs)
All AEs will be assessed according to NCI CTCAE v5.0
Measured: From registration until 28 days after last trial treatment dose
Quality of life (QoL): Core 30 (QLQ-C30)
QoL is measured by the Questionnaire Core 30 (QLQ-C30) including the complementary Lung Cancer Module (QLQ-LC13)
Measured: From registration until trial treatment discontinuation or the latest 1 year after registration
Geriatric assessment (GA) - Screening instrument (G8)
Screening instrument (G8)
Measured: At baseline
Geriatric assessment (GA) - Assessment with IADL
Assessment with IADL
Measured: At baseline
Geriatric assessment (GA)
Comorbidities assessment with CCI
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start4 Dec 2018
- Primary completion19 Jan 2023
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-arm open-label multicenter phase II trial
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Mark, MD, Study chair, Kantonsspital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620669
- Sponsor's protocol ID
- SAKK 19/17
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2018
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03620669
- Acronym / sponsor ID
- SAKK 19/17
- Conditions
- NSCLC Stage IV, NSCLC Stage IIIB
- Keywords
- Lung cancer, Durvalumab, PD-L1, NSCLC, Phase II, PS 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm open-label multicenter phase II trial
| Arm | Type | Receives |
|---|---|---|
| Durvalumab | Experimental | Drug: DurvalumabDurvalumab until progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736Durvalumab 1500mg q4W until progression or unacceptable toxicity | Drug | Durvalumab |
Primary outcome
Overall survival (OS) at 6 months
Time frame: At 6 months after registration
OS at 6 months is defined as being alive at 6 months after registration.
12 secondary outcomes
Objective response (OR) according to RECIST 1.1
Time frame: At trial treatment discontinuation or the latest 5 years after last patient discontinued trial treatment
Objective response according to iRECIST (iOR)
Time frame: At trial treatment discontinuation or the latest 5 years after last patient discontinued trial treatment
Duration of response (DoR) according to RECIST 1.1
Time frame: 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)
Time frame: 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
Time frame: 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
Progression-free survival according to iRECIST (iPFS)
Time frame: At disease progression according to iRECIST criteria (iPD) or death due to any reason or the latest 5 years after last patient discontinued trial treatment
Overall survival (OS)
Time frame: At death of the patient or the latest 5 years after last patient discontinued trial treatment
Adverse events (AEs)
Time frame: From registration until 28 days after last trial treatment dose
Quality of life (QoL): Core 30 (QLQ-C30)
Time frame: From registration until trial treatment discontinuation or the latest 1 year after registration
Geriatric assessment (GA) - Screening instrument (G8)
Time frame: At baseline
Geriatric assessment (GA) - Assessment with IADL
Time frame: At baseline
Geriatric assessment (GA)
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mark, MD study chair
Kantonsspital Graubünden
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab in people with NSCLC Stage IV and NSCLC Stage IIIB, run by Swiss Cancer Institute at 11 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) at 6 months (time frame: At 6 months after registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.