Status: Closed
Activation Date: 2019OCT17
Closing Date: 2022APR05
Phase: II
Description: A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Non-Small Cell Lung Cancer
Eligibility: Eligibility: MAIN INCLUSION CRITERIA: Patients with metastatic NSCLC that is EGFR and ALK mutation negative, PD-L1 expression Tumour Proportion Score (TPS) ? 50% who are willing and able to receive continued pembrolizumab or addition of standard platinum-based combination therapy added to pembrolizumab after initial 6 weeks (after 2 Q3W doses or 1 Q6W dose) of pembrolizumab as systemic immunotherapy. ECOG 0-2. Clinically/radiologically evaluable disease, RECIST 1.1 measurable disease not required. Mandatory blood collection of ctDNA for screening. MAIN EXCLUSION CRITERIA: Symptomatic/unstable CNS metastases. Patients who are not suitable candidates for treatment with pembrolizumab as a single agent or in combination with standard platinum combination chemotherapy.
Objective: Primary: Phase II progression free survival (PFS), Phase III overall survival (OS). Secondary: Phase II feasibility, RECIST response rate post randomization, safety/tolerability; Phase III RECIST response rate post randomization, response duration, progression free survival, and safety/tolerability.
Participation: Open to member centres
Lay Description: This is planned as a two stage study. Stage 1 of the study will evaluate if blood tests can be used to see how the cancer responds to treatment with pembrolizumab. Stage 2 will be finalized once stage 1 is completed with a plan to use blood tests to evaluate if patients whose cancer does not seem to be getting better on treatment with pembrolizumab would do better on a different treatment.
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Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
LUNG | BR36 | 50 | 19 | 0 | 19 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
LUNG | BR36 | 50 | 0 | 0 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
LUNG | BR36 | 50 | 0 | 0 | 0 | 0 | 50 | 0 | 0 | 0 |