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

Primary Purpose

Lung Cancer Metastatic

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Tremelimumab
Platinum-Based Drug
Sponsored by
Canadian Cancer Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Campbelltown Hospital
  • Coffs Habour Health Campus - NCCI
  • Concord Repatriation General Hospital
  • Nepean Hospital
  • St. George Hospital, Cancer Care Centre
  • The Tweed Hospital
  • Liverpool Cancer Therapy Centre, Liverpool Hospital
  • Prince of Wales Hospital
  • Princess Alexandra Hospital
  • The Prince Charles Hospital
  • Mater Research Institute South Brisbane
  • Gold Coast University Hospital
  • Toowoomba Hospital
  • Royal Hobart Hospital
  • Ballarat Health Services
  • Epworth HealthCare - Richmond
  • Border Medical Oncology
  • Saint John of God Hospital Subiaco
  • St. Vincent's Hospital
  • Cross Cancer Institute
  • BCCA - Fraser Valley Cancer Centre
  • BCCA - Vancouver Cancer Centre
  • Horizon Health Network
  • The Moncton Hospital
  • The Vitalite Health Network - Dr. Leon Richard
  • Regional Health Authority B, Zone 2
  • Cambridge Memorial Hospital
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • Kingston Health Sciences Centre
  • Grand River Regional Cancer Centre
  • Stronach Regional Health Centre at Southlake
  • Ottawa Hospital Research Institute
  • Algoma District Cancer Program
  • Niagara Health System
  • Health Sciences North
  • North York General Hospital
  • Humber River Regional Hospital
  • Michael Garron Hospital
  • University Health Network
  • Windsor Regional Cancer Centre
  • PEI Cancer Treatment Centre
  • Hopital de la Cite-de-la-Sante
  • CHUM-Centre Hospitalier de l'Universite de Montreal
  • The Jewish General Hospital
  • CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
  • University Institute of Cardiology and
  • Centre hospitalier universitaire de Sherbrooke
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Durvalumab and Tremelimumab

Platinum based chemotherapy + Durvalumab + Tremelimumab

Arm Description

Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses

4 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

Outcomes

Primary Outcome Measures

Overall Survival
time from randomization to the date of death

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 15, 2017
Last Updated
August 3, 2023
Sponsor
Canadian Cancer Trials Group
Collaborators
AstraZeneca, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT03057106
Brief Title
Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
February 24, 2020 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Cancer Trials Group
Collaborators
AstraZeneca, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, National Health and Medical Research Council, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Durvalumab and Tremelimumab
Arm Type
Active Comparator
Arm Description
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Arm Title
Platinum based chemotherapy + Durvalumab + Tremelimumab
Arm Type
Active Comparator
Arm Description
4 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
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
MEDI4736
Intervention Type
Drug
Intervention Name(s)
Tremelimumab
Intervention Description
Tremelimumab
Intervention Type
Drug
Intervention Name(s)
Platinum-Based Drug
Intervention Description
Pemetrexed, cisplatin, carboplatin or gemcitibine
Primary Outcome Measure Information:
Title
Overall Survival
Description
time from randomization to the date of death
Time Frame
33 months
Secondary Outcome Measure Information:
Title
Progression-free Survival Using RECIST 1.1
Description
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.
Time Frame
33 months
Title
Objective Response Rate Using RECIST 1.1 and iRECIST
Description
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.
Time Frame
33 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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 Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natasha Leighl
Organizational Affiliation
Princess Margaret Hospital, Toronto, ON Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Campbelltown Hospital
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
Coffs Habour Health Campus - NCCI
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
St. George Hospital, Cancer Care Centre
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
The Tweed Hospital
City
Lismore
State/Province
New South Wales
ZIP/Postal Code
2480
Country
Australia
Facility Name
Liverpool Cancer Therapy Centre, Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Mater Research Institute South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Toowoomba Hospital
City
Toowoomba
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Ballarat Health Services
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Epworth HealthCare - Richmond
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Saint John of God Hospital Subiaco
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
St. Vincent's Hospital
City
Victoria Park
ZIP/Postal Code
3065
Country
Australia
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BCCA - Fraser Valley Cancer Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
BCCA - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Horizon Health Network
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5N5
Country
Canada
Facility Name
The Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
The Vitalite Health Network - Dr. Leon Richard
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Regional Health Authority B, Zone 2
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Cambridge Memorial Hospital
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 3G2
Country
Canada
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Grand River Regional Cancer Centre
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Stronach Regional Health Centre at Southlake
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Algoma District Cancer Program
City
Sault Ste. Marie
State/Province
Ontario
ZIP/Postal Code
P6B 0A8
Country
Canada
Facility Name
Niagara Health System
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada
Facility Name
Health Sciences North
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
North York General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Facility Name
Humber River Regional Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada
Facility Name
Michael Garron Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
PEI Cancer Treatment Centre
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 8T5
Country
Canada
Facility Name
Hopital de la Cite-de-la-Sante
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
CHUM-Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
The Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
University Institute of Cardiology and
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34800700
Citation
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.
Results Reference
result

Learn more about this trial

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

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