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Not yet recruitingNCT07698054Updated Jul 13, 2026

Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer

A Phase 2 interventional study of Toripalimab; Etoposide in SCLC, Extensive Stage, Bayesian and Metronomic Chemotherapy, sponsored by Henan Cancer Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Henan Cancer Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • SCLC, Extensive Stage
  • Bayesian
  • Metronomic Chemotherapy
03

In context

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 1.Age ≥18 years old, both male and female are acceptable.
  • 2. Histology and pathology diagnosis of extensive stage small cell lung cancer, and must meet the following standards:

    1. always has not received the immune therapy,
    2. Previously received immunotherapy, with the number of treatment lines ≥2 and the immunotherapy being effective(immunotherapy PFS > 3 months, withdrawal time > 3 months)
    3. never used anlotinib,
  • 3. ECOG: 0 \~ 2;
  • 4 . The expected lifetime 12 weeks or more;
  • 5. Major organs function normal

Exclusion criteria

Exclusion Criteria:

  • 1.Those who are allergic to toripalimab or etoposide or have metabolic disorders;
  • 2.With known the special ripley sheet resistance, etoposide contraindication;
  • 3.Other circumstances that the researcher assessed as unsuitable for participation in this clinical study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Etoposide

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

    Drug: Toripalimab; Etoposide

  • Experimental
    Etoposide+Toripalimab

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

    Drug: Toripalimab; Etoposide

  • Experimental
    Toripalimab+Etoposide+Anlotinib

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

    Drug: Toripalimab; Etoposide

  • Experimental
    Toripalimab+Etoposide+Carboplatin

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

    Drug: Toripalimab; Etoposide

  • Experimental
    Etoposide+Toripalimab+Temozolomide

    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

  • DrugToripalimab; Etoposide

    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

06

What researchers measure

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

    Time frame: 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07698054
Lead sponsor
Henan Cancer Hospital
Responsible party
Sponsor
First posted
Jul 13, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Jan 1, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jul 13, 2026

Study contacts

Qiming Wang
Contact
qimingwang1006@126.com
4000371818

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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