Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab

Sponsor
Fondazione Ricerca Traslazionale
Study ID
NCT05568212
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Non-small-cell Lung Cancer Patients

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab concentrate for solution for infusion will be supplied in glass vials containing 500 mg durvalumab at a concentration of 50 mg/mL
  • Olaparib tablet — DRUG
    Olaparib tablets (100 mg and 150 mg strengths) supplied in high-density polyethylene (HDPE) bottles.
  • Single-agent chemotherapy — DRUG
    Investigator's choice single-agent chemotherapy regimen
  • Platinum doublet chemotherapy — DRUG
    Investigator's choice platinum doublet chemotherapy

Study Details

This is a randomized, non-comparative, phase II study investigating whether: 1) the addition of durvalumab to investigator's choice second line chemotherapy prolongs survival versus investigator's choice second line chemotherapy in NSCLC patients with locally advanced disease progressing on durvalumab given after concomitant chemoradiotherapy; 2) whether the addition of olaparib to durvalumab improves survival over durvalumab alone after induction chemoimmunotherapy in patients relapsing after completing durvalumab maintenance therapy for stage III disease. After evaluation of inclusion and exclusion criteria and after consent form signature, all eligible patients progressing during durvalumab therapy will be in the Part A of the trial randomized to in a 1:1 ratio to investigator's choice single-agent chemotherapy plus durvalumab (Arm A: experimental arm) or to investigator's choice single-agent chemotherapy (Arm B: standard arm). In the clinical trial's Part B, patients progressing after completion of durvalumab therapy will be further randomized in a 1:1.7 ratio to investigator's choice platinum doublet chemotherapy plus durvalumab for 4 cycles followed by maintenance durvalumab plus olaparib (Arm C: experimental arm) or to investigator's choice platinum doublet chemotherapy plus durvalumab for 4 cycles followed by durvalumab (Arm D: experimental arm). Therapy will be continued up to disease progression, toxicity or patient refusal.

Key Dates

Start date
May 2, 2022
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

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

Arms

  • Experimental: ARM A (experimental arm)
    Investigator's choice single-agent chemotherapy plus durvalumab 1500 mg every 3 weeks.
  • Experimental: ARM B (standard arm)
    Investigator's choice single-agent chemotherapy.
  • Experimental: ARM C
    Investigator's choice platinum doublet chemotherapy plus durvalumab 1500 mg every 3 weeks for 4 cycles followed by maintenance durvalumab 1500 mg every 3 weeks plus olaparib 300 mg twice daily.pp
  • Experimental: ARM D (experimental arm)
    Investigator's choice platinum doublet chemotherapy plus durvalumab 1500 mg every 3 weeks for 4 cycles followed by maintenance durvalumab 1500 mg every 3 weeks

Primary Outcome Measure

Overall survival (OS) [ Time Frame: 12 months ]

Central Contacts