| Title |
An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients With Non-Small Cell Lung Cancer, Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy. |
| Protocole ID |
D6185C00001 (HUDSON) |
| ClinicalTrials.gov ID |
NCT03334617 |
| Cancer Type(s) |
Non Small Cells - Lung |
| Phase |
Phase II |
| Stage |
Metastatic |
| Study Type |
Treatment |
| Drug |
Durvalumab + AZD9150 vs AZD6738 vs Vistusertib vs Olaparib |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
Montréal |
| Principal Investigator |
Dr. Marie Florescu
|
| Coordinator |
Francine Richard
514-890-8000 poste 24853
|
| Status |
Temporary interruption |
| Activation Date |
17-10-2018 |
| Eligibility Criteria |
- At least 18 years of age at the time of signing the informed consent form.
- Patient must have histologically or cytologically confirmed metastatic or recurrent NSCLC which is progressing.
- Patient may be second- or later-line NSCLC patient, and must have documented radiological and/or clinical progression on a prior anti-PD-1/PD-L1 containing therapy.
- Suitable for a new tumour biopsy.
- ECOG/WHO performance status of 0 to 1, and a minimum life expectancy of 12 weeks.
- Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
|
| Exclusion Criteria |
- Patients whose tumour samples have targetable alterations in EGFR and/or ALK are excluded. In addition, patients whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded.
- Active or prior documented autoimmune or inflammatory disorders.
- Active infection including hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
- Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Patient has spinal cord compression or symptomatic brain metastases.
- Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis.
- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
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Groupe d'étude en oncologie du Québec