MAGE-A3 as Adjuvant Non-Small Cell Lung Cancer Immunotherapy
- Conditions
- on-Small Cell Lung CancerNon-Small Cell Lung CancerCancer - Lung - Non small cellCancer - Biliary tree (gall bladder and bile duct)
- Registration Number
- ACTRN12609000062224
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 2270
1. Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC (non-small cell lung cancer).
2. The patient's tumor shows expression of MAGE-A3 gene
3. The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy.
4. The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI (magnetic resonance imaging) of the brain.
Other examinations should be performed as clinically indicated.
5. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the time of randomization.
6. Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria.
1. The primary tumor was removed by segmentectomy or wedge resection.
2. The patient shows any evidence of residual tumor after surgery.
3. The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except:
- For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years),
- Administration of adjuvant platinum-based chemotherapy for the treatment of the current NSCLC is allowed between surgery and randomization.
4. The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured.
5. History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
6. The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
7. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted.
8. The patient has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
9. The patient needs home oxygenation.
10. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint will be disease-free survival (DFS). Two primary co-objectives are considered:<br><br>Objective A: Efficacy (DFS) in the overall population)<br><br>Objective B: Efficacy (DFS) in the population of patients who did not receive adjuvant chemotherapy.[The main analysis of treatment efficacy on the overall population (Objective A) will consist in the evaluation of DFS as soon as 881 patients have a documented recurrence or death.<br><br>The main analysis of treatment efficacy on the no-chemotherapy population (Objective B) will consist in the evaluation of DFS as soon as 413 patients have a documented recurrence.]
- Secondary Outcome Measures
Name Time Method Overall survival[Defined as the interval from randomization to the date of death, irrespective of the cause of death];Lung-cancer-specific survival[Defined as the interval from randomization to the date of death due to lung cancer];Disease-free survival (defined as the interval from the date of randomization to the date of the first objective evidence of recurrence or to the date of death, if before recurrence).[At 2, 3, 4 and 5 years after first study treatment];Disease-free specific survival (only lung cancer-related events will be taken into account; deaths due to other or unknown causes, and new primary cancer other than lung will not be taken into account).[At final analysis, which will be performed as soon as 881 patients have a documented disease recurrence or death.]