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NSCLC Non-small Cell Lung CancerPhase 2NCT02572843

Anti-PD-L1 in Stage IIIA(N2) Non-small Cell Lung Cancer (NSCLC)

A Phase 2 study testing MEDI4736 (anti-PD-L1) in people with NSCLC Non-small Cell Lung Cancer, run by Swiss Cancer Institute at 19 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of the trial is to demonstrate that the addition of neoadjuvant and adjuvant immunotherapy (with the anti-PD-L1 antibody MEDI4736) to standard neoadjuvant chemotherapy (with cisplatin/docetaxel) in primary resectable stage IIIA(N2) NSCLC is efficacious and feasible. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC Non-small Cell Lung Cancer
What is being tested?
MEDI4736 (anti-PD-L1)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
19 sitesSwitzerland
Study dates
16 Jun 2016to 19 Mar 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent according to ICH-GCP regulations before patient registration and any protocol-related procedures.
  • Pathologically proven NSCLC (adeno-, squamous-, large cell carcinoma or NSCLC not otherwise specified) irrespective of genomic aberrations or PD-L1 expression status.
  • Tumor tissue is available for the mandatory translational research (preferably histology, cytology allowed).
  • Tumor stage T1-3N2M0 (stage IIIA(N2)) according to the TNM classification, 7th edition, (October 2009). Mediastinal lymph node staging has to follow the process chart.
  • Tumor is considered resectable based on a multidisciplinary tumor board decision made before neoadjuvant treatment. Resectable is when a complete resection can be achieved according to Rami-Porta {Rami-Porta, 2005 #88}.
  • Measurable disease according to RECIST 1.1 criteria (non-nodal lesions ≥10 mm in longest diameter, lymph nodes ≥15 mm in short axis) by PET/CT with contrast enhanced CT-scan.
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  • WHO performance status 0-1.
  • Age 18-75 years at time of registration.
  • Appropriate lung function based on the ESTS guidelines {Brunelli, 2009 #19}:
  • For pneumonectomy: FEV1 and DLCO ≥80%. If one of both <80% an exercise test peak VO2 >75% or 20ml/kg/min is needed,
  • For resection less than pneumonectomy (resection up to the calculated extent): exercise test peak VO2 ≥35% or ≥10ml/kg/min, with predicted postoperative FEV1 and DLCO ≥ 30%.
  • Adequate hematological values: hemoglobin ≥ 90 g/L, absolute neutrophils count ≥ 1.5 x 109/L, platelets count ≥ 100 x 109/L.
  • Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 1.5 x ULN, AP ≤ 2.5 x ULN.
  • Adequate renal function: calculated creatinine clearance ≥ 60 mL/min, according to the formula of Cockcroft-Gault.
  • Women with child-bearing potential are using effective contraception are not pregnant or lactating and agree not to become pregnant during participation in the trial and during 90 days after the last treatment. A negative serum pregnancy test performed within 7 days before registration into the trial is required for all women with child-bearing potential. Men agree not to father a child during participation in the trial and during 90 days after the last treatment.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.

Who cannot join

  • Presence of any distant metastasis or N3 disease. Brain metastases have to be excluded by CT or MRI.
  • Sulcus superior tumors (Pancoast tumors).
  • Previous or concomitant malignancy within 5 years prior registration with the exception of adequately treated localized non-melanoma skin cancer or cervical carcinoma in situ.
  • Any previous treatment for NSCLC.
  • Any previous treatment with a PD-1 or PD-L1 inhibitor, including MEDI4736.
  • Previous radiotherapy to the chest.
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  • Absolute contraindications for the use of corticosteroids as premedication.
  • Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to registration.
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, 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) and the premedication for chemotherapy.
  • Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 3 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
  • Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Bazett's Correction.
  • Preexisting peripheral neuropathy (> grade 1).
  • Body weight less than 30 kg.
  • Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: - Vitiligo or resolved childhood asthma/atopy - Hypothyroidism stable on hormone replacement or Sjorgen's syndrome
  • Active or prior documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis).
  • Known evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
  • History of primary immunodeficiency.
  • History of allogeneic organ transplant.
  • Known history of previous clinical diagnosis of tuberculosis.
  • Receipt of live attenuated vaccination any time during trial therapy with MEDI4736 and within 30 days of receiving the last dose of MEDI4736.
  • Any concomitant drugs contraindicated for use with MEDI4736: this includes systemic corticosteroids, methotrexate, azathioprine, and tumor necrosis factor (TNF)-α blockers. Any concomitant drugs contraindicated for use with the other trial drugs according to the locally approved product information.
  • Known hypersensitivity to trial drugs (cisplatin and docetaxel), to the IMP or to any excipient.
  • Any other serious underlying medical (e.g. uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, severe hearing impairment), psychiatric, psychological, familial or geographical condition that, 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Switzerland19 sites

  • Kantonsspital Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, 5404

  • St. Claraspital Basel

    Basel, 4016

  • Universitaetsspital Basel

    Basel, 4031

  • IOSI Ospedale Regionale di Bellinzona e Valli

    Bellinzona, 6500

  • Inselspital Bern

    Bern, CH-3010

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Spital Thurgau AG

    Frauenfeld, CH-8500

  • Hopital Fribourgeois HFR

    Fribourg, 1708

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • CCAC Lausanne

    Lausanne, 1004

  • Centre hospitalier universitaire vaudois CHUV

    Lausanne, CH-1011

  • Luzerner Kantonsspital

    Lucerne, CH-6000

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Regionalspital

    Thun, 3600

  • Kantonsspital Winterthur

    Winterthur, CH-8401

  • Stadtspital Triemli

    Zurich, Canton of Zurich, 8063

  • Klinik Hirslanden Onkozentrum Zürich

    Zurich, CH-8032

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: Anti-PD-L1 Antibody MEDI4736 in Addition to Neoadjuvant Chemotherapy in Patients With Stage IIIA(N2) Non-small Cell Lung Cancer (NSCLC). A Multicenter Single-arm Phase II Trial.

The objective of the trial is to demonstrate that the addition of neoadjuvant and adjuvant immunotherapy (with the anti-PD-L1 antibody MEDI4736) to standard neoadjuvant chemotherapy (with cisplatin/docetaxel) in primary resectable stage IIIA(N2) NSCLC is efficacious and feasible.

Read the detailed description

Despite multimodal therapy, the cure rate of patients with stage IIIA NSCLC is poor and therapy outcome failed to improve during the past years. The addition of immunotherapy with the anti-PD-L1 antibody MEDI4736 as a novel treatment modality has the potential to improve the outcome without adding substantial toxicity to an otherwise intensive multimodality treatment, as MEDI4736 has been generally well tolerated. Based on the current evidence on immune checkpoint inhibition, there is a strong rationale to test this novel treatment modality also in the curative setting in order to improve local tumor control and prevent distant metastasis to improve the cure rate in this patient population.

The trial investigates the addition of pre- and post-operative immune checkpoint inhibition with MEDI4736 to the previously established standard of care for stage IIIA(N2) patients, which is based on the trials SAKK16/96 and SAKK16/00. Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin (100 mg/m2) / docetaxel (85 mg/m2), followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.

Being tested
MEDI4736 (anti-PD-L1)
Keywords
NSCLC, lung cancer, MEDI4736, non-small cell lung cancer, immunotherapy, anti-PD-L1
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.

  • MEDI4736 (anti-PD-L1)Drug

    Also called durvalumab

    fixed dosing 750 mg

Study groups in NCT02572843
Study groupRoleWhat they receive
MEDI4736ExperimentalPatients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
Receives: Drug: MEDI4736 (anti-PD-L1)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free Survival (EFS) Rate

    Measured using the Kaplan-Meier method

    Measured: at 12 months

Secondary outcomes (6)

  1. Median Event-free Survival (EFS)

    Measured using the Kaplan-Meier method

    Measured: up to 7 years from registration

  2. Overall Survival (OS) Rate

    Measured using the Kaplan-Meier method

    Measured: at 1, 2, 3, 4 & 5 years after registration

  3. Objective Response (OR) After Neoadjuvant Chemotherapy (FAS)

    Measured: After Neoadjuvant Chemotherapy, up to 3 months

  4. Objective Response (OR) After Neoadjuvant Immunotherapy (FAS II)

    Measured using the Kaplan-Meier method

    Measured: After Neoadjuvant immunotherapy, up to 3 months

  5. Pathological Responses (pCR)

    Measured: at 12 months

  6. Adverse Events (AEs) (According to NCI CTCAE v4.0)

    Outcomes are described under "Adverse events".

    Measured: Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2015 (estimated)
  2. Study start16 Jun 2016
  3. Primary completion20 Jan 2020
  4. Study completion19 Mar 2024

Resources

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
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02572843
Sponsor's protocol ID
SAKK 16/14
Other IDs
000001480
Status last verified
Oct 2025
First submitted
1 Oct 2015
Last updated
28 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schmid D, Sobottka B, Manzo M, Trub M, Leonards K, Herzig P, Oyewole OR, Jermann P, Hayoz S, Savic Prince S, Tochtermann G, Natoli M, Pless M, Bettini A, Fruh M, Mauti LA, Britschgi C, Peters S, Mark M, Ochsenbein AF, Janthur WD, Waibel C, Mach N, Froesch P, Buess M, Bohanes P, Gonzalez M, Alborelli I, Rothschild SI, Koelzer VH, Zippelius A. Tumor immune dynamics and long-term clinical outcome of stage IIIA NSCLC patients treated with neoadjuvant chemoimmunotherapy. Nat Commun. 2025 Sep 30;16(1):8673. doi: 10.1038/s41467-025-63696-5.

    PubMed 41027867

  • Rothschild SI, Zippelius A, Eboulet EI, Savic Prince S, Betticher D, Bettini A, Fruh M, Joerger M, Lardinois D, Gelpke H, Mauti LA, Britschgi C, Weder W, Peters S, Mark M, Cathomas R, Ochsenbein AF, Janthur WD, Waibel C, Mach N, Froesch P, Buess M, Bohanes P, Godar G, Rusterholz C, Gonzalez M, Pless M; Swiss Group for Clinical Cancer Research (SAKK). SAKK 16/14: Durvalumab in Addition to Neoadjuvant Chemotherapy in Patients With Stage IIIA(N2) Non-Small-Cell Lung Cancer-A Multicenter Single-Arm Phase II Trial. J Clin Oncol. 2021 Sep 10;39(26):2872-2880. doi: 10.1200/JCO.21.00276. Epub 2021 Jul 12.

    PubMed 34251873

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI4736 (anti-PD-L1) in people with NSCLC Non-small Cell Lung Cancer, run by Swiss Cancer Institute at 19 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 16 inclusion and 23 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: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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?

Yes. Results are posted in the registry (first posted 28 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Event-free Survival (EFS) Rate (time frame: at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02572843, which also lists 2 linked publications.

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 28 Oct 2025.

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