Durvalumab Plus Etoposide-free Chemotherapy in First-line Treatment of Extensive-disease Small-sell Lung Cancer (SCLC)

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT05856695
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Small Cell Lung Cancer Extensive Stage

Eligibility Criteria

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

Interventions

  • Carboplatin + Paclitaxel + Durvalumab — DRUG
    Carboplatin AUC 6, day 1 of three-week cycle for four cycles Paclitaxel 200 mg/m² day 1 of a three-week cycle for four cycles Durvalumab 1500 mg every 3 weeks for 4 cycles followed by 1500 mg maintenance every 4 weeks until progression, unacceptable toxicity, or consent withdrawal

Study Details

The current study is intended to be a "proof of concept" to evaluate the potential value of synergy between paclitaxel carboplatin and immunotherapy. If a signal clearly shows superiority over the CASPIAN data , we will have arguments to think that the combination of paclitaxel and carboplatin is more suitable for synergy with immunotherapy than the standard etoposide and carboplatin.

Key Dates

Start date
Nov 17, 2023
Status verified
Sep 2025
Primary completion
Feb 28, 2026
Completion
Feb 29, 2028

Study Design

Enrollment
67 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin + Paclitaxel + Durvalumab
    Carboplatin AUC 6, day 1 of three-week cycle for four cycles Paclitaxel 200 mg/m² day 1 of a three-week cycle for four cycles Durvalumab 1500 mg every 3 weeks for 4 cycles followed by 1500 mg maintenance every 4 weeks until progression, unacceptable toxicity, or consent withdrawal

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: At 12 months ]

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