A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC

Sponsor
University of Leeds
Study ID
NCT04550104
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiotherapy — RADIATION
    Administered as 30 fractions of 2Gy. Total 60 60Gy. Administered once daily monday to friday.
  • Olaparib Oral Tablet [Lynparza] — DRUG
    Oral tablet
  • AZD1390 — DRUG
    Oral tablet
  • Ceralasertib — DRUG
    Oral Tablet
  • AZD5305 — DRUG
    Oral Tablet
  • Durvalumab — DRUG
    1500mg iv infusion

Study Details

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.

Key Dates

Start date
Mar 17, 2021
Status verified
Mar 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Radiotherapy only
  • Experimental: Olaparib + radiotherapy
  • Experimental: AZD1390 + radiotherapy
  • Experimental: Ceralasertib (AZD6738) + radiotherapy + Consolidation durvalumab
    This study arm will include up to 12 months of consolidation durvalumab for eligible participants following the completion of radiotherapy +/- DDRi.
  • Experimental: AZD5305 + radiotherapy + Consolidation durvalumab
    This study arm will include up to 12 months of consolidation durvalumab for eligible participants following the completion of radiotherapy +/- DDRi.
  • Active Comparator: RT + consolidation durvalumab
  • Experimental: Arm D - did not proceed
    Arm D - did not proceed

Primary Outcome Measure

Dose limiting Toxicities [ Time Frame: 13.5 months after start of radiotherapy ]

Central Contacts

Related Studies