Low-dose Radiotherapy Combined With Durvalumab, Chemotherapy(EP) in the Treatment of ES-SCLC

Sponsor
You Lu
Study ID
NCT05092412
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Durvalumab
  • Extensive-stage Small-cell Lung Cancer
  • Lung Cancer

Eligibility Criteria

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

Interventions

  • Low-dose radiotherapy — RADIATION
    The LDRT deals with primary tumour in a 15 Gy of 5fractions over five days, starting from Day 1 in the first cycle.
  • Durvalumab — DRUG
    Durvalumab 1500 mg intravenous infusion, started to be used simultaneously with chemotherapy at week 0 and continued after chemotherapy.
  • Etoposide, and cisplatin/carboplatin — DRUG
    Starting from week 0, the dose of etoposide + carboplatin or cisplatin in the study will not exceed the dose for specific indications in the product instructions (etoposide \[80 to 100mg/m2\] via intravenous infusion and carboplatin \[ The area under the curve (AUC) is 5-6\] by intravenous infusion or cisplatin \[75-80 mg/m2\] by intravenous infusion), using up to 4 cycles. The choice of platinum drugs is at the discretion of the investigator.

Study Details

The purpose of this study was to evaluate the efficacy of low-dose radiotherapy (LDRT) combined with durvalumab, etoposide, and cisplatin/carboplatin in the first-line treatment of extensive-stage small cell lung cancer.

Key Dates

Start date
Mar 2, 2022
Status verified
May 2026
Primary completion
Feb 6, 2023
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: up to 2 years ]

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