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Lomustine Combined With Anlotinib as Interventional Therapy for Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Above Treatment

ConditionSCLC, Extensive Stage
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYayi He

About this trial

This single-arm phase II study aims to evaluate the efficacy and safety of lomustine combined with anlotinib in patients with extensive-stage small cell lung cancer resistant to second-line and above systemic treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1: Aged 18-75 years, without gender restriction.

Disqualifiers

1: Previous treatment with lomustine, anlotinib, or other similar anti-angiogenic TKIs.

Trial design

Design model

Single group

Treatments tested in this trial

  • Lomustine

    Drug

    Oral lomustine 60 mg/m² once daily on day 1, every 6 weeks

  • Anlotinib

    Drug

    Oral administration, initial dose 12 mg, 10 mg or 8 mg once daily on days 1-14 of every 3-week cycle

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: lomustine combined with anlotinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate

Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with Lomustine combined with anlotinib

Time frame
Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months

Secondary outcomes

1

progression free survival

Time from first treatment to disease progression or death from any cause, whichever occurs first

Time frame
Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
2

Disease Control Rate (DCR)

According to RECIST 1.1, proportion of subjects achieving CR, PR, or stable disease (SD) in total enrolled population

Time frame
Time Frame: Baseline and after every 2 treatment cycles (each cycle is 21 days), up to disease progression, death, or study withdrawal, whichever occurs first，assessed up to approximately 24 months
3

Adverse Event (AE)

Record all new or worsening unfavorable medical events, grade and calculate incidence according to CTCAE 5.0

Time frame
From signing informed consent through study completion and safety follow-up, assessed up to approximately 24 months
4

Quality of Life Score（QOL Score）

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was adopted for patient self-assessment. The scale consists of 30 items, including 5 functional scales, 9 symptom scales and 1 global health status / quality of life scale. Each item is scored on a 1-4 Likert scale, and all scale scores are standardized to a range of 0-100. Higher scores in functional and global quality of life scales and lower scores in symptom scales indicate better quality of life and health status of patients.

Time frame
At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Yayi He

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Sponsor institution

Source ClinicalTrials.gov

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