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Protocol NumberBR.31

2015-02-25 - 2025-12-31

Phase III

Not yet recruiting2

Recruiting3

Terminated8

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A PHASE III PROSPECTIVE DOUBLE BLIND PLACEBO CONTROLLED RANDOMIZED STUDY OF ADJUVANT MEDI4736 IN COMPLETELY RESECTED NON-SMALL CELL LUNG CANCER

  • Trial Applicant

    Clinipace Taiwan Co., Ltd

  • Sponsor

    Canadian Clinical Trials Group , CCTG

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 何景良 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

  • 葉人華 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chi-Lu Chiang Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 楊聰明 Division of Thoracic Medicine
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 張晟瑜 Division of Thoracic Medicine
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 吳健樑 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 吳健樑 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王佐輔 Division of Hematology & Oncology
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

COMPLETELY RESECTED NON-SMALL CELL LUNG CANCER

Objectives

Primary Objective To assess in comparison to placebo, the impact of adjuvant therapy with MEDI4736 given by intravenous infusion for one year on the disease free survival of patients with completely resected (stage IB > 4cm, stage II or IIIA), non-small cell lung cancer that is PD-L1 positive. Secondary Objectives To compare the overall survival in the MEDI4736 arm to the placebo arm in patients with NSCLC that is PD-L1 positive. To compare the overall survival in the MEDI4736 arm to the placebo arm in all randomized patients. To compare lung cancer specific survival in the MEDI4736 arm to the placebo arm for patients with PD-L1+ NSCLC as well as all randomized patients. To evaluate the nature, severity, and frequency of toxicities, between arms. To evaluate the quality of life between the two arms. To determine the survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile, and the factors influencing their preferences. To determine the incremental cost effectiveness and cost utility ratios for MEDI4736. To evaluate the prognostic and predictive significance of PD-L1 expression. To evaluate changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at the first disease event (relapse or new invasive primary malignancy). To explore polymorphisms that may be associated with outcomes.

Test Drug

MEDI4736

Active Ingredient

MEDI4736

Dosage Form

10 mL Vial

Dosage

50

Endpoints

Primary
• Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive.

Secondary
• DFS in all randomized patients.
• Overall survival (OS) for patients with NSCLC that is PD-L1 positive.
• OS for all randomized patients.
• Lung cancer specific survival for patients with NSCLC that is PD-L1 positive and all randomized patients.
• Adverse effects and tolerability of MEDI4736.
• Quality of life.
• Survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile.
• Economic evaluation (cost effectiveness and cost utility).
• Evaluation of predictive/prognostic significance of PD-L1 expression.
• Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event.
• Exploratory pharmacogenomic assays (baseline only).

Inclution Criteria

Patients must have an adequate histopathology (see Section 13), must consent to release of an adequate histological specimen for this protocol, and the tissue blocks must be available for submission after registration. Local policy must permit the submission of tissue blocks. It is the centres’ responsibility to notify NCIC CTG immediately of any changes in local policy that would preclude the submission of tissue blocks. If local policy requires this, blocks must have been stored in the Institutional Research Bank at the time of surgery to allow submission of blocks. Failure to provide tissue blocks for PD-L1 expression assessment will render the patient ineligible. Slides only will NOT be acceptable for PD-L1 expression assessment.

After registration but prior to randomization, tissue blocks from the surgically resected NSCLC must be submitted for PD-L1 assessment and the result must be available prior to randomization (see Sections 6 and 13). Initially patients will not be selected for PD-L1 status. After 600 patients have been randomized, only patients with PD-L1 positive tumours will be enrolled.
2.Patients must be classified post-operatively as Stage IB (> 4cm in the longest diameter), II or IIIA on the basis of pathologic criteria.
3.Surgery and Previous Therapy for NSCLC
Surgery:
• A pre-surgical PET scan of the thorax and a MRI or CT scan of the brain is considered standard of care and thus must be done prior to surgery. Patients in whom this was not done prior to surgery may still be enrolled providing that appropriate imaging is performed prior to randomization (see Section 6).
• Complete surgical resection of the primary NSCLC is also mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. Resection may be accomplished by open or VATS techniques.
• Lymph node mapping is defined by The International Association for the Study of Lung Cancer (IASLC) lymph node map. The nodal tissue must be labelled according to the recommendations of the American Thoracic Society. Surgeons are encouraged to dissect or sample all accessible nodal levels in accordance with the European Society of Thoracic Surgeons guidelines. Accordingly, a minimum of 3 (three) lobe specific mediastinal nodal stations (N2), one of which must include station 7, and at least one N1 station - inclusive of the ones removed with the pulmonary specimen - must have been sampled at the end of the procedure.
• If preoperative CT and/or PET are suspicious for mediastinal nodal involvement, invasive
mediastinal staging with mediastinoscopy or EBUS-TBNA should be performed. Station 5 or 6 lymph nodes may be accessed by anterior mediastinotomy or VATS. Complete mediastinal lymph node dissection is required for stage IIIA tumours.
•Surgery may consist of lobectomy, sleeve resection, bilobectomy or pneumonectomy as
determined by the attending surgeon based on the intraoperative findings. Patients who have had only segmentectomies or wedge resections are not eligible for this study.

Prior Systemic Therapy:
• Pre-operative (neo-adjuvant) platinum based or other chemotherapy is not permissible.
• Patients may have received prior post-operative platinum based chemotherapy as per standard of care. Patients who discontinue chemotherapy for toxicity prior to completion of all planned chemotherapy are eligible.
• If adjuvant platinum based chemotherapy is given, it is strongly recommended that this be started within 8 weeks of surgery.
• Patients must have recovered from all acute, reversible toxic effects from chemotherapy
(excluding alopecia).
• Patients who have not received adjuvant chemotherapy, and meet all other eligibility criteria, may be eligible under the following circumstances:
− All patients who are eligible for adjuvant chemotherapy MUST be offered adjuvant
chemotherapy prior to any discussion about this trial and that must be documented.
− The patient has declined adjuvant chemotherapy, and in the opinion of the investigator, this is the patient’s final decision after receiving appropriate information and adequate time to make the decision.
− If in the view of the investigator, adjuvant chemotherapy is contraindicated due to an
underlying intercurrent illness/ laboratory abnormality, which is not considered reversible
within a reasonable timeframe for the patient to be eligible for adjuvant therapy, which must be documented.
• No prior anticancer therapy for treatment of NSCLC other than standard post-operative adjuvant chemotherapy is permissible.

Radiation：
• Pre-operative or post-operative or planned radiation therapy is not permissible.
Timing between surgery and adjuvant chemotherapy and randomization:
Surgery:
• A minimum of 3 weeks must have elapsed between NSCLC surgery and randomization. A
minimum of 4 weeks must have elapsed for other types of surgery. Complete post-operative wound healing must have occurred following any surgery.
• No more than 10 weeks may have elapsed between surgery and randomization for patients who have not received adjuvant chemotherapy.
For patients after adjuvant chemotherapy:
• For patients who received post-operative adjuvant platinum-based chemotherapy, a minimum of 2 weeks must have elapsed (but no more than 10 weeks) from the last administered dose of chemotherapy to the date of randomization.
4. The patient must have an ECOG performance status of 0, 1.
5. Hematology (done within 14 days prior to randomization and with values within the ranges specified below): If anemic, patients should be asymptomatic and should not be decompensated. Transfusions are permissible.
Absolute neutrophil count > 1.5 x 109/L or > 1,500/µl
Platelets > 100 x 109/L or > 100,000/µl
6. Biochemistry (done within 14 days prior to randomization and with values within the ranges specified below):
Total bilirubin* within normal institutional limits
Alkaline phosphatase < 2.5 x institutional upper limit of normal
AST(SGOT) and ALT(SGPT) < 2.5 x institutional upper limit of normal
Creatinine Clearance > 50 ml/min
* excluding Gilbert’s syndrome
Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by
Cockcroft Formula:
Females: GFR = 1.04 x (140-age) x weight in kg / serum creatinine in μmol/L
Males: GFR = 1.23 x (140-age) x weight in kg / serum creatinine in μmol/L
7. Other investigations detailed in Section 6 must have been performed within the timelines indicated.
8. Patient able (i.e. sufficiently fluent) and willing to complete the quality of life, economics and other questionnaires. The baseline assessment must already have been completed within required timelines prior to randomization. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
9. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participat.
10. Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
11. In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient randomization.
12. Age of at least 18 years.

Exclusion Criteria

Patients who fulfill any of the following criteria are not eligible for admission to the study:
1. Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 yearsfollowing the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
2. A combination of small cell and non-small cell lung cancer or pulmonary carcinoid tumour.
3. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
NOTE: patients with Grave’s disease and/or psoriasis not requiring systemic therapy within the last two years from randomization are not excluded.
4. History of primary immunodeficiency, history of 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.
* NOTE: Intranasal/inhaled corticosteroids or systemic steroids that do not to exceed 10 mg/day of prednisone or equivalent dose of an alternative corticosteroid are permissible.
5. Live attenuated vaccination administered within 30 days prior to randomization.
6. History of hypersensitivity to MEDI4736 or any excipient.
7. Patients who have experienced 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 controlled, should have a LVEF > 50% within 12 weeks prior to randomization.
8. Concurrent treatment with other investigational drugs or anti-cancer therapy.
9. Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:
• known prior history of tuberculosis;
• known acute hepatitis B or C by serological evaluation;
• known Human immunodeficiency virus infection.
10. Pregnant or lactating women. Women of childbearing potential must have a urine pregnancy test proven negative within 14 days prior to randomization. Men and women of child-bearing potential must agree to use adequate contraception as described in Section 11.3.1.

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    1360 participants

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