NCT07698054

Brief Summary

This study is a randomized, open-label, multi-center investigator-initiated clinical trial. Patients who meet the inclusion criteria receive the treatment plan stipulated in the protocol. A Bayesian design is used to explore the efficacy and safety of teprotumumab combined with pulse chemotherapy in the treatment of advanced second-line extensive-stage small cell lung cancer.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
54mo left

Started Aug 2026

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

July 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

May 6, 2026

Last Update Submit

July 9, 2026

Conditions

SCLC, Extensive StageBayesianMetronomic Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • ORR

    According to the RECIST 1.1 standard, the proportion of patients whose tumors have shrunk to a complete response (CR) or partial response (PR) and have maintained this condition for at least 4 weeks

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (5)

Etoposide

EXPERIMENTAL

Etoposide: PO, 50 mg, d1-d14, Q3W

Drug: Toripalimab; Etoposide

Etoposide+Toripalimab

EXPERIMENTAL

Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W；

Drug: Toripalimab; Etoposide

Toripalimab+Etoposide+Anlotinib

EXPERIMENTAL

Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Anlotinib: 12mg, d1-d14, PO, Q3W;

Drug: Toripalimab; Etoposide

Toripalimab+Etoposide+Carboplatin

EXPERIMENTAL

Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Carboplatin: AUC=5, d1, ivgtt, Q3W

Drug: Toripalimab; Etoposide

Etoposide+Toripalimab+Temozolomide

EXPERIMENTAL

Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Temozolomide: 75mg/m ² /d, d1-d21, PO, Q4W;

Drug: Toripalimab; Etoposide

Interventions

Toripalimab; EtoposideDRUG

Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； carboplatin: AUC=5，d1， ivgtt,， Q3W； temozolomide:75mg/m2/d，d1-d21，PO，Q4W; Anlotinib:12mg，d1-d14 PO，Q3W

Also known as: Etoposide；, carboplatin, temozolomide, Anlotinib
EtoposideEtoposide+ToripalimabEtoposide+Toripalimab+TemozolomideToripalimab+Etoposide+AnlotinibToripalimab+Etoposide+Carboplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years old, both male and female are acceptable.
  • \. Histology and pathology diagnosis of extensive stage small cell lung cancer, and must meet the following standards:
  • always has not received the immune therapy,
  • Previously received immunotherapy, with the number of treatment lines ≥2 and the immunotherapy being effective(immunotherapy PFS \> 3 months, withdrawal time \> 3 months)
  • never used anlotinib,
  • \. ECOG: 0 \~ 2;
  • The expected lifetime 12 weeks or more;
  • \. Major organs function normal

You may not qualify if:

  • Those who are allergic to toripalimab or etoposide or have metabolic disorders;
  • With known the special ripley sheet resistance, etoposide contraindication;
  • Other circumstances that the researcher assessed as unsuitable for participation in this clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

toripalimabEtoposideCarboplatinTemozolomideanlotinib

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCoordination ComplexesDacarbazineTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Qiming Wang

CONTACT

4000371818qimingwang1006@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

July 13, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

July 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share