Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer

Sponsor
Institut Bergonié
Study ID
NCT05572476
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Association of lurbinectedin and durvalumab — DRUG
    A treatment cycles consists of 3 weeks (i.e. 21 days). Lurbinectedin will be administered by intravenous infusion on Day 1 every 3 weeks. Durvalumab will be administered by intravenous infusion on Day 1 every 3 weeks.
  • Association of carboplatin and etoposide — DRUG
    Treatment will be administered on a 21-days cycle basis up to a maximum of 6 cycles. Carboplatin will be administered by intravenous infusion on Day 1 every 3 weeks. Etoposide will be administered by intravenous infusion on Day 1-3 every 3 weeks

Study Details

Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab

Key Dates

Start date
Oct 31, 2023
Status verified
Jun 2024
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm A: treatment by lurbinectedin and durvalumab
    Patients with with platinum sensitive extensive stage small-cell lung cancer (SCLC) which failed one prior platinum-containing regimen will be treated by the association of lurbinectedin and durvalumab
  • Other: Standard Arm B: treatment by carboplatin and etoposide
    Patients with with platinum sensitive extensive stage small-cell lung cancer (SCLC) which failed one prior platinum-containing regimen will be treated by the association of carboplatin and etoposide

Primary Outcome Measure

Assessment of the antitumor activity of lurbinectedin combined with durvalumab [ Time Frame: 6 months ]

Related Studies