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

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.

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Key information

Conditions

SCLC, Extensive Stage Bayesian Metronomic Chemotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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,
3. ECOG: 0 ~ 2;
4 . The expected lifetime 12 weeks or more;
5. Major organs function normal

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.

Treatment and study plan

Toripalimab; Etoposide

Drug

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

Other names: Etoposide；, carboplatin, temozolomide, Anlotinib

Primary outcomes

ORR

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Qiming Wang

CONTACT

[email protected]

4000371818

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

A Prospective, Open-label, Bayesian Adaptive Randomized Phase II Clinical Study of Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Jul 13, 2026
Registry last updated: Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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