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Lung Cancer MetastaticPhase 2NCT03057106

Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC

A Phase 2 study testing Durvalumab, Tremelimumab and Platinum-Based Drug in people with Lung Cancer Metastatic, run by Canadian Cancer Trials Group at 49 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Durvalumab is a new type of drug for many kinds of cancer. It is considered "immunotherapy" and not "chemotherapy". Laboratory tests show that it works by allowing the immune system to detect cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer Metastatic
What is being tested?
Durvalumab, Tremelimumab and Platinum-Based Drug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
49 sitesin 2 countries
Study dates
28 Mar 2017to 30 Dec 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically and/or cytologically confirmed diagnosis of squamous or non-squamous, non-small cell carcinoma of the lung. Patients with poorly differentiated tumours will only be eligible if NSCLC is confirmed by immunohistochemistry markers (TTF1/P63 or P40/CK5). Patients with known sensitizing EGFR mutations or known ALK-fusion are not eligible.
  • Patients must have stage IV disease according to the 8th TNM version staging.
  • Patients must have an adequate histopathology specimen and must consent to release this specimen for protocol required testing. This is a mandatory component of the study.
  • Patient must consent to provision of samples of blood in order that the specific correlative marker assays proscribed may be conducted.
  • All patients must have measurable disease as defined by RECIST 1.1 All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).
  • The criteria for defining measurable disease are as follows:
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  • CT scan (with slice thickness of 5 mm) ≥ 10 mm --> longest diameter
  • Physical exam (using calipers) ≥ 10 mm
  • Lymph nodes by CT scan ≥ 15 mm --> measured in short axis
  • Measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented.
  • Patients must be 18 years of age or older.
  • ECOG performance status of 0 or 1.
  • Absolute neutrophils ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Hemoglobin ≥ 90 g/L
  • Bilirubin ≤ 1.5 x UNL (upper limit of normal)
  • AST and ALT ≤ 2.5 x UNL (if liver metastases are present, ≤5 x UNL) Creatinine < 1.25 UNL or Creatinine clearance ≥ 45 mL/min
  • Cytotoxic Chemotherapy: Patients may not have received prior cytotoxic chemotherapy for advanced/metastatic disease.
  • Adjuvant Chemotherapy: Patients may have had prior adjuvant therapy for completely resected disease, providing it has been completed at least 12 months prior to randomization.
  • Patients treated with concurrent chemotherapy/radiation regimens for unresectable locally advanced Stage III disease will be eligible providing it has been completed at least 12 months prior to randomization.
  • Other Systemic Therapy: Patients may not have received prior EGFR or alk inhibitors. Patients may not have received prior treatment with immune-based therapy, including durvalumab and tremelimumab vaccines or oncolytic viral therapy. Patients must have recovered from any reversible treatment related toxicities prior to randomization.
  • Prior external beam radiation is permitted provided a minimum of 14 days (2 weeks) have elapsed between the last dose of radiation and date of randomization. Concurrent radiotherapy is not permitted.
  • Patients must have recovered from any acute toxic effects from radiation prior to randomization.
  • Patients must have recovered from any acute toxic effects from radiation prior to randomization.
  • Surgery: Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed (major surgery) prior to randomization.
  • Patient must be able (i.e. sufficiently fluent) and willing to complete the quality of life and health economics questionnaires.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
  • Patients must be accessible for treatment and follow-up. All randomized patients must be followed and treated at participating centres.
  • In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient randomization.
  • Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception while on study and for 6 months after the last dose of durvalumab and tremelimumab or for 3 months after the last dose of durvalumab alone

Who cannot join

  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years. Patients with a history of other malignancies detected at an early stage and whom the investigator believes have been curatively treated and are at low risk of recurrence MAY be eligible. Contact CCTG to discuss eligibility prior to enrolling.
  • 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, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
  • Patients with alopecia.
  • Patients with Grave's disease, vitiligo or psoriasis not requiring systemic treatment (within the last 2 years).
  • Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement.
  • History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy or grade ≥ 3 infusion reaction.
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  • Live attenuated vaccination administered within 30 days prior to randomization
  • History of hypersensitivity to durvalumab or tremelimumab or any excipient. Patients who have received other treatment or other antibodies must not have had intolerable toxicity or required steroids to manage toxicity.
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec in screening ECG measured using standard institutional method or history of familial long QT syndrome.
  • Patients who have untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if now controlled, should have a LVEF ≥ 45%. (Note: patients with uncomplicated controlled hypertension do not require LVEF measurement in the absence of other significant cardiac history)
  • Concurrent treatment with other investigational drugs or anti-cancer therapy
  • Patients with untreated brain or meningeal metastases are not eligible. Patients with treated CNS disease who have radiologic AND clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization).
  • Pregnant or Lactating Women: Women of childbearing potential must have a pregnancy test (urine or serum) proven negative within 14 days prior to randomization. If urine test is positive, pregnancy testing may then include an ultrasound to rule-out pregnancy if a false-positive is suspected. For example, when beta-human chorionic gonadotropin is high and partner is vasectomized, it may be associated with tumour production of hCG, as seen with some cancers. Patient will be considered eligible if an ultrasound is negative for pregnancy. Men and women of child-bearing potential must agree to use adequate contraception.
  • Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (including corticosteroid administration), or would put the patient at risk. This includes but is not limited to:
  • Contraindications to the use of pemetrexed, gemcitabine, cisplatin and/or carboplatin (consult product monograph);
  • History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements;
  • Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis);
  • Active peptic ulcer disease or gastritis;
  • Known pneumonitis or pulmonary fibrosis with clinically significant impairment of pulmonary function.

Trial locations and contacts

49 sites in 2 countries.

49 sites in 2 countries

Canada30 sites

  • Cambridge Memorial Hospital

    Cambridge, Ontario, N1R 3G2

  • PEI Cancer Treatment Centre

    Charlottetown, Prince Edward Island, C1A 8T5

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Horizon Health Network

    Fredericton, New Brunswick, E3B 5N5

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • Hopital de la Cite-de-la-Sante

    Laval, Quebec, H7M 3L9

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • The Vitalite Health Network - Dr. Leon Richard

    Moncton, New Brunswick, E1C 8X3

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)

    Québec, Quebec, G1J 1Z4

  • University Institute of Cardiology and

    Québec, Quebec, G1V 4G5

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Regional Health Authority B, Zone 2

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Algoma District Cancer Program

    Sault Ste. Marie, Ontario, P6B 0A8

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Niagara Health System

    St. Catharines, Ontario, L2S 0A9

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • North York General Hospital

    Toronto, Ontario, M2K 1E1

  • Humber River Regional Hospital

    Toronto, Ontario, M3M 0B2

  • Michael Garron Hospital

    Toronto, Ontario, M4C 3E7

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Australia19 sites

  • Ballarat Health Services

    Ballarat, Victoria, 3350

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Coffs Habour Health Campus - NCCI

    Coffs Harbour, New South Wales, 2450

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Nepean Hospital

    Kingswood, New South Wales, 2751

  • St. George Hospital, Cancer Care Centre

    Kogarah, New South Wales, 2217

  • The Tweed Hospital

    Lismore, New South Wales, 2480

  • Liverpool Cancer Therapy Centre, Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Epworth HealthCare - Richmond

    Richmond, Victoria, 3121

  • Mater Research Institute South Brisbane

    South Brisbane, Queensland, 4101

  • Gold Coast University Hospital

    Southport, Queensland, 4215

  • Saint John of God Hospital Subiaco

    Subiaco, Western Australia, 6008

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350

  • St. Vincent's Hospital

    Victoria Park, 3065

  • Border Medical Oncology

    Wodonga, Victoria, 3690

Other trials in Australia

About this study

Official title: A Randomized Trial of Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Durvalumab is a new type of drug for many kinds of cancer. It is considered "immunotherapy" and not "chemotherapy". Laboratory tests show that it works by allowing the immune system to detect cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals and has been studied in more than 5000 people and seems promising.

Tremelimumab is a new type of drug for various types of cancers. It works in a similar way to durvalumab and may improve the effect of durvalumab. Tremelimumab may also help slow the growth of the cancer cells or may cause cancer cells to die. It has been shown to shrink tumours in animals and has been studied in over 1200 people and seems promising.

Read the detailed description

Combinations of durvalumab and tremelimumab have also been studied. While the combination has been studied in over 200 people, it is not clear if it can offer better results when it is combined with chemotherapy.

Recently, immunotherapies that target the PD-1/PD-L1 axis have shown promise in treating patients with non-small cell lung cancer.

Being tested
Durvalumab, Tremelimumab, Platinum-Based Drug

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    MEDI4736

  • TremelimumabDrug

    Tremelimumab

  • Platinum-Based DrugDrug

    Pemetrexed, cisplatin, carboplatin or gemcitibine

Study groups in NCT03057106
Study groupRoleWhat they receive
Durvalumab and TremelimumabActive comparatorDurvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Receives: Drug: Durvalumab; Drug: Tremelimumab
Platinum based chemotherapy + Durvalumab + TremelimumabActive comparator4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles) Followed by: Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD
Receives: Drug: Durvalumab; Drug: Tremelimumab; Drug: Platinum-Based Drug

What is being measured

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

  1. Overall Survival

    time from randomization to the date of death

    Measured: 33 months

Secondary outcomes (2)

  1. Progression-free Survival Using RECIST 1.1

    time from randomization to the date of the first documented disease progression. Progression was defined as: at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) AND an absolute increase of ≥5 mm, or appearance of new lesions.

    Measured: 33 months

  2. Objective Response Rate Using RECIST 1.1 and iRECIST

    proportion of patients with a documented complete response, partial response (CR + PR) based on iRECIST criteria. The primary estimate of ORR will be based on all patients randomized, and compared using Cochran- Mantel-Haeszel test stratified by stratification factors at randomization between the study new treatment and the standard control arms.

    Measured: 33 months

Timeline

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

  1. First posted17 Feb 2017
  2. Study start28 Mar 2017
  3. Primary completion24 Feb 2020
  4. Study completion30 Dec 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03057106
Sponsor's protocol ID
BR34
Status last verified
Feb 2026
First submitted
15 Feb 2017
Last updated
1 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leighl NB, Laurie SA, Goss GD, Hughes BGM, Stockler M, Tsao MS, Hwang DM, Joubert P, Kulkarni S, Blais N, Joy AA, Mates M, Rana P, Yadav SK, Underhill C, Lee C, Bradbury PA, Hiltz A, Dancey J, Ding K, Vera-Badillo F; Canadian Cancer Trials Group Lung Disease Site and the Australasian Lung Cancer Trials Group. CCTG BR34: A Randomized Phase 2 Trial of Durvalumab and Tremelimumab With or Without Platinum-Based Chemotherapy in Patients With Metastatic NSCLC. J Thorac Oncol. 2022 Mar;17(3):434-445. doi: 10.1016/j.jtho.2021.10.023. Epub 2021 Nov 17.

    PubMed 34800700

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, Tremelimumab and Platinum-Based Drug in people with Lung Cancer Metastatic, run by Canadian Cancer Trials Group at 49 sites in 2 countries.

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 30 inclusion and 19 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Canada, Australia. 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 9 Feb 2022). 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?

Overall Survival (time frame: 33 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 NCT03057106, which also lists 1 linked publication.

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 1 Sep 2026.

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