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Post-line Treatment With Teniposide for c-Myc-driven Extensive-stage Small Cell Lung Cancer

ConditionsExtensive-stage Small Cell Lung Cancer (ES-SCLC)Thoracic NeoplasmsLung NeoplasmsLung Diseases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

The study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-Myc-driven FBXW2/MYC gene. Based on the results, the study will explore the correlation between the expression of FBXW2/MYC and the efficacy of teniposide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

extensive stage small cell lung cancer

Progression after receiving at least one chemotherapy drug treatment in the past;

ECOG score 0-1

c-Myc-driven

Disqualifiers

No measurable lesions

Other severe and persistent diseases or organ system dysfunction;

Women planning pregnancy or men planning family planning;

Women who are pregnant or breastfeeding;

Trial design

Design model

Single group

Treatments tested in this trial

  • Teniposide administration

    Drug

    Teniposide administration: 60mg/m2, diluted with 500ml of 0.9% sodium chloride injection before use, intravenous infusion for more than 1 hour, for 3-5 consecutive days, with 21 days as one cycle of treatment.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Teniposide groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Time frame
Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, through study completion, an average of 1 year

Secondary outcomes

1

Disease Control Rate

Time frame
Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, through study completion, an average of 1 year
2

Progression Free Survial

Time frame
Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, until progression or death, an average of 1 year
3

Duration of Response

Time frame
Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, until progression or death, an average of 1 year
4

Adverse events(AEs), serious adverse events（SAEs）as assessed by CTCAE v5.0

Time frame
From Baseline up to 30 days after the last dose

Other outcomes

Sponsors and contacts

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

Shanghai Pulmonary Hospital, Shanghai, China

Lead sponsor

CHINA RESOURCES DOUBLE-CRANE PHARMACEUTICAL CO.,LTD

Collaborator

Source ClinicalTrials.gov
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