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

ConditionExtensive-stage Small-cell Lung Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Adebrelimab, Irinotecan Liposome (II)

    Drug

    Adebrelimab:1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W Escalating doses to determine recommended phase 2 dose (RP2D) of Irinotecan Liposome (II). Participants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II).

  • Adebrelimab, Irinotecan Liposome (II), Famitinib

    Drug

    Adebrelimab:1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W Famitinib: RP2D, QO, QD Escalating doses to determine recommended phase 2 dose (RP2D) of Famitinib. Participants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II) and Famitinib.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Adebrelimab plus Irinotecan Liposome (II)Experimental treatment 1 intervention
Group B: Adebrelimab plus Irinotecan Liposome (II) and FamitinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-month progression-free survival

Proportion of disease progression or death from randomization to 6 months of treatment.

Time frame
Up to 6 months

Secondary outcomes

1

Safety

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

Time frame
Up to 3 months after the last dose
2

Objective response rate

Objective response rate, determined according to RECIST v1.1 criteria.

Time frame
Up to 36 months
3

Progression-free survival

Progression Free Survival, determined according to RECIST v1.1 criteria.

Time frame
Up to 36 months
4

Overall survival

Overall survival is the time from randomization to death due to any reason or loss of follow-up.

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baohui Han

Lead sponsor

Shanghai Chest Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: