Actively Recruiting
A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC
Led by University of Leeds · Updated on 2025-12-19
200
Participants Needed
14
Research Sites
363 weeks
Total Duration
On this page
Sponsors
U
University of Leeds
Lead Sponsor
U
University of Manchester
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Not suitable for concurrent chemoradiotherapy or surgery due to tumor or patient factors
- Stage IIB or III NSCLC (TNM 8th Edition)
- Planned curative intent radiotherapy of 60 Gy (30 fractions)
- Suitable for radical radiotherapy as determined by local multidisciplinary team and oncologist
- If prior chemotherapy given, start radiotherapy within 10 weeks
- Age 18 years or older
- Life expectancy more than 6 months
- Karnofsky Performance status 70 or higher
- MRC dyspnoea score less than 3
- Forced expiratory volume in one second (FEV1) 35% predicted or higher
- Lung diffusing capacity (DLCO or TLCO) 35% predicted or higher
- Fully informed and signed consent form
- Willing and able to comply with protocol and use effective contraception during and after treatment as specified
- Adequate organ function as defined in master protocol
- Body weight greater than 30 kg
You will not qualify if you...
- Mixed non-small cell and small cell tumors
- Progressive disease during induction chemotherapy
- Participation in investigational agent or device study within 4 weeks before treatment
- Other malignant diseases affecting life expectancy (except NSCLC)
- History of interstitial pneumonitis
- Prior thoracic radiotherapy
- Prior pneumotoxic drug treatment within past year or pulmonary toxicity history
- Corrected QT interval (QTcF) over 470 msec
- Prior organ or tissue transplantation
- Unable to swallow oral medications or gastrointestinal disease affecting drug absorption
- Grade 2 or higher peripheral sensory neuropathy
- Positive HIV, active hepatitis B or C infection
- Positive pregnancy test or breastfeeding women
- Persistent toxicities greater than grade 2 from prior cancer therapy (excluding alopecia)
- Myelodysplastic syndrome or acute myeloid leukemia or suggestive features
- Major surgery within 2 weeks before eligibility
- Poor medical risk due to serious uncontrolled disorders or infections
- Active or prior autoimmune or inflammatory disorders
- Progressive disease during or after radiotherapy
- Decline consolidation phase treatment
- Prior anti-PD-1 or anti-PD-L1 treatment
- Major surgery within 4 weeks before consolidation eligibility
- Recent immunosuppressive medication use
- Poor medical risk for consolidation phase due to serious disorder or infection
- Active or prior autoimmune or inflammatory disorders (consolidation phase)
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Belfast City Hospital
Belfast, United Kingdom
Actively Recruiting
2
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Actively Recruiting
3
Addenbrooke's Hospital
Cambridge, United Kingdom
Actively Recruiting
4
Velindre Cancer Centre
Cardiff, United Kingdom
Actively Recruiting
5
The Royal Marsden Hospital Chelsea
Chelsea, United Kingdom
Actively Recruiting
6
Western General Hospital
Edinburgh, United Kingdom
Actively Recruiting
7
St James's University Hospital
Leeds, United Kingdom
Actively Recruiting
8
The Clatterbridge Cancer Centre
Liverpool, United Kingdom
Actively Recruiting
9
St Bartholomew's Hospitals
London, United Kingdom
Actively Recruiting
10
University College Hospital London
London, United Kingdom
Actively Recruiting
11
The Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
12
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, United Kingdom
Actively Recruiting
13
Weston Park Hospital
Sheffield, United Kingdom
Actively Recruiting
14
The Royal Marsden Sutton
Sutton, United Kingdom
Actively Recruiting
Research Team
J
Jamie B Oughton, MPhil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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