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Low-dose Radiotherapy Combined With Concurrent Chemotherapy, Toripalimab and Tifcemalimab in the Treatment of ES-SCLC

NCT06732258 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2026-04-29

No results posted yet for this study

Summary

To evaluate the tolerability and safety of Low-dose radiotherapy combined with concurrent Chemotherapy, Toripalimab and Tifcemalimab in first-line treatment of Extensive-Stage Small Cell Lung Cancer, and to determine the RP2D.

Conditions

  • Extensive-stage Small-cell Lung Cancer

Interventions

RADIATION

Low-dose radiotherapy

The LDRT deals with primary tumour in a 15 Gy of 5 fractions over five days, starting from Day 1 in the first cycle.

DRUG

Tifcemalimab injection

100 mg or 200 mg q3w until disease progression or intolerable toxicity;

DRUG

Toripalimab

240 mg q3w until disease progression or intolerable toxicity;

DRUG

Cisplatin

75 mg/m2 q3w for 4-6 cycles;

DRUG

Carboplatin

AUC = 5, q3w for 4-6 cycles;

DRUG

Etoposide

100 mg/m2, d1, d2, d3, q3w for 4-6 cycles;

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2026-02-28
Completion
2028-02-29

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06732258 on ClinicalTrials.gov