To Evaluate the Efficacy of Durvalumab + Anlotinib in Terms of OS and PFS.

Sponsor
Shanghai Chest Hospital
Study ID
NCT04985851
Status
Unknown

Conditions

  • Extensive-Stage Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • durvalumab + anlotinib — DRUG
    Approximately 64 patients who complete the 4 cycles of durvalumab + EP treatment and don't have progressive diseases (Non-PD patients) will be randomized in a 1:1 ratio to receive maintenance treatment durvalumab + anlotinib (Arm 1) or durvalumab (Arm 2) until confirmed progressive disease.
  • Durvalumab — DRUG
    durvalumab

Study Details

This is an open-label, randomised, multicenter, Phase II study. This study is planned to enroll 90 eligible patients to receive durvalumab combined with up to 4 cycles of etoposide and platinum-based chemotherapy (EP). And approximately 64 patients who complete the 4 cycles of durvalumab + EP treatment and don't have progressive diseases (Non-PD patients) will be randomized in a 1:1 ratio to receive maintenance treatment durvalumab + anlotinib (Arm 1) or durvalumab (Arm 2) until confirmed progressive disease. Prophylactic cranial irradiation (PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab. Tumor assessments will be performed at Screening with follow-up at Week 6 ±1 week and Week 12 ±1 week from the date of the first cycle treatment, and then every 8 weeks ±1 week until confirmed objective disease progression.

Key Dates

Start date
Sep 28, 2021
Status verified
Nov 2023
Primary completion
Jun 1, 2024
Completion
Dec 1, 2024

Study Design

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

Arms

  • Experimental: maintenance treatment durvalumab + anlotinib
    Durvalumab 1500 mg monotherapy will be continued q4w. Anlotinib will be administered according to prescribing information in general use. The dose is 12mg, QD, PO, 14 days-on and 7 days-off. * N.B. If a patient's weight falls to 30 kg or below (≤30 kg) the patient should receive weight-based dosing equivalent to 20 mg/kg of durvalumab until the weight improves to \>30 kg, at which point the patient should start receiving the fixed dosing of durvalumab 1500 mg. * Anlotinib is available at three dose levels, 12 mg, 10 mg, and 8 mg. Dose reduction may take place whenever toxicity that is not controlled with optimal supportive care is noted during the study. If a subject subsequently tolerates treatment well at that level in the judgment of the investigator, the dose may be increased to the next dose level. If a subject cannot tolerate treatment after dose reduction to 8 mg, treatment will be discontinued
  • Active Comparator: maintenance treatment durvalumab
    Durvalumab 1500 mg monotherapy will be continued q4w.

Primary Outcome Measure

PFS-Progression Free Survival [ Time Frame: 2 years ]

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