CONCORDE is a multi-institution, multi-arm, Phase IB study that will determine the recommended phase II dose (RP2D) and safety profiles of different DNA damage repair inhibitors (DDRis) when given in an open label fashion in combination with fixed dose curative intent radiotherapy (RT) in patients with stage IIB/IIIA/IIIB NSCLC, followed by up to 12 months of consolidation durvalumab immunotherapy in selected study arms. The RP2D will be evaluated by incorporating the number of observed dose limiting toxicities (DLTs) into a time to event continuous reassessment method (TiTE- CRM) model within each of the experimental arms. TiTE-CRM is used here to take into account longer-term toxicities up to 13.5 months post start of radiotherapy and use these to inform dose escalation decision making.
Radiotherapy is an effective treatment for patients with non-small cell lung cancer (NSCLC) that has not spread beyond the chest area. Radiotherapy is used as a curative treatment but unfortunately for most patients the cancer can return. Radiotherapy kills cells by damaging their DNA. Cells have the ability to repair that damage, especially the cells of normal tissue. If DNA repair can be prevented radiotherapy should be more effective causing the cancer cells to die. The study will use new drugs that affect how cells repair DNA damage, called DNA damage response inhibitors (DDRi). These will be given together with radiotherapy to hopefully improve the effectiveness of radiotherapy, followed by up to 12 months of durvalumab immunotherapy in selected study arms to develop the trial in line with the standard of care for NSCLC. The study will try to find out the most effective and safe dose of this combination treatment. This will be a clinical trial where patients due to have radiotherapy, with the hope of successful treatment that could lead to cure from their cancer or extension of life, will be offered entry onto the study. All patients will receive their radiotherapy, with 3 out of every 4 people also receiving a single DDRi drug alongside this. Both patients and study doctors will know prior to the start of the actual treatment whether a DDRi will be given, and if so which one; no placebos will be used. The patients will be followed closely to check for side effects and to assess how their cancer is responding to treatment. Blood samples will be taken to monitor treatment progress and to try to predict which patients are most likely to benefit from this type of combined treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Administered as 30 fractions of 2Gy. Total 60 60Gy. Administered once daily monday to friday.
Oral tablet
Oral tablet
Oral Tablet
Oral Tablet
1500mg iv infusion
Belfast City Hospital
Belfast, United Kingdom
RECRUITINGBirmingham Heartlands Hospital
Birmingham, United Kingdom
RECRUITINGAddenbrooke's Hospital
Cambridge, United Kingdom
RECRUITINGVelindre Cancer Centre
Cardiff, United Kingdom
RECRUITINGThe Royal Marsden Hospital Chelsea
Chelsea, United Kingdom
RECRUITINGWestern General Hospital
Edinburgh, United Kingdom
RECRUITINGSt James's University Hospital
Leeds, United Kingdom
RECRUITINGThe Clatterbridge Cancer Centre
Liverpool, United Kingdom
RECRUITINGSt Bartholomew's Hospitals
London, United Kingdom
RECRUITINGUniversity College Hospital London
London, United Kingdom
RECRUITING...and 4 more locations
Dose limiting Toxicities
Dose-limiting toxicities (DLTs), within 13.5 months of starting radiotherapy, in order to establish the Recommended Phase II Dose (RP2D) of each DDRi-RT combination.
Time frame: 13.5 months after start of radiotherapy
Safety and toxicity
Safety will be reported based on the occurrence of SAEs, SARs and SUSARs. Toxicity will be reported based on adverse events, as graded by CTCAE V5.0, and determined by routine clinical assessments at each centre.
Time frame: 2 years after end of RT
Treatment compliance
Treatment compliance will be measured by overall radiotherapy treatment time and delays, omissions and reductions to treatment doses (both DDRi and RT).
Time frame: End of trial treatment (DDRi and RT)
Best overall response
Best overall response will be measured as the best response (complete response, partial response or stable disease) recorded until disease progression, reported up to 2 years post-RT. This will be assessed using RECIST 1.1
Time frame: 2 years after end of RT
Disease control
This will be assessed using the Green Criteria. Disease Control includes either the complete disappearance of all evidence of malignant disease or residual radiographic abnormalities assessed by chest CT scan at 3 and 6 months after completion of RT, which then remains stable for an additional 6 months or more and which then qualifies as controlled local disease.
Time frame: 2 years after end of RT
Progression-free survival
Participants who have not progressed at the time of analysis will be censored at the last date they were known to be alive and progression free
Time frame: 2 years post-RT
Overall survival
Participants who have not died at the time of analysis will be censored at the last date they were known to be alive
Time frame: 2 years post-RT
Changes in Health Related Quality of Life
Health Related Quality of Life will be determined using EORTC QLQ-C30, IL-73 and IL-74
Time frame: 2 years after end of RT
Objective response rate
Objective response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy. The proportion of patients with evaluable scans that achieve at least a partial response, as defined by RECIST v1.1(31), will be presented with 95% confidence intervals.
Time frame: 2 years after end of RT
Changes in tumour size during and following treatment with DDRi-RT compared to RT alone.
Time frame: 2 years after end of RT
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