Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBaohui Han

About this trial

This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s).

Eligibility criteria

Qualifiers

Willing to participate and sign the informed consent form.

Age: 18-75 years old, male or female.

ECOG PS: 0-1 points.

Histologically or cytologically confirmed of extensive stage small cell lung cancer (according to the International Association for the Study of Lung Cancer, 8th Edition or VALG II staging system).

Disqualifiers

Non-small cell lung cancer or non-small cell lung cancer admixed with components of small cell lung cancer, as confirmed by histology or cytology.

With > 2 lines of prior chemotherapy.

Patients previously treated with topoisomerase I inhibitors.

With primary resistance, defined as patients who do not respond to first-line treatment or progress within 90 days after the end of treatment.

Trial design

Treatments tested in this trial

  • Adebrelimab, Irinotecan Liposome (II)
  • Adebrelimab, Irinotecan Liposome (II), Famitinib

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Baohui Han

Lead sponsor

Shanghai Chest Hospital

Sponsor institution