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A Single-arm, Multicenter, Prospective Phase II Clinical Study of Apatinib in Combination With Adebrelimab and EC Regimen in the First-line Treatment of Extensive Small Cell Lung Cancer

ConditionSmall Cell Lung Cancer Extensive Stage
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

To evaluate the efficacy and safety of apatinib combined with adebrelizumab and EC in the first-line treatment of extensive small cell lung cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Patients with extensive stage small cell lung cancer confirmed by histopathology or cytology (excluding complex small cell lung cancer);

2. Age at the time of signing the informed consent: 18-75 years old (including 18 and 75 years old), male or female;

3. The physical status of the Eastern Oncology Consortium (ECOG) was 0 or 1 (see Annex 1 for the ECOGPS scoring criteria);

4. Have not received systematic treatment for extensive small cell lung cancer;

Disqualifiers

1. Known allergy to any of the drugs in the study;

2. Previous or co-existing malignancies other than cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast (DCIS), papillary carcinoma of the thyroid gland, and other malignancies that have been adequately treated and cured for ≥5 years prior to the first dose with evidence of no recurrence or metastasis;

3. Presence of symptomatic or active central nervous system (CNS) metastases or cancerous meningitis (patients with asymptomatic or stable brain metastases after treatment are allowed to be included);

4. Active or previously suffering from autoimmune disease or immune deficiency;

Trial design

Design model

Single group

Treatments tested in this trial

  • Apatinib

    Drug

    250mg, P.O, qd, 21 days per cycle;

  • Adebrelimab

    Drug

    20mg/kg or 1200mg ivgtt, d1, 21 days per cycle;

  • Etoposide Injection

    Drug

    100mg/m\^2 ivgtt for the first, second and third consecutive days, 21 days per cycle.

  • Carboplatin Injection

    Drug

    Day 1 administration, AUC=5, intravenous infusion; One treatment cycle every 21 days.

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

Defined as the time from the start of enrollment to the date when objective tumor progression was first recorded or to death from any cause, whichever occurs first.

Time frame
0ne year

Secondary outcomes

1

Objective remission rate

Proportion of subjects with CR and PR (RECIST v1.1 standard)

Time frame
one year
2

Disease control rate

Proportion of subjects with CR and PR and SD (RECIST v1.1 standard)

Time frame
one year
3

Overall survival

Defined as the time between enrollment and the subject's death from various causes;

Time frame
2 years
4

Safety and tolerance evaluated by incidence, severity and outcomes of AEs

Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

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