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Chemoradiotherapy and Dual Immune Checkpoint Blockade for Limited-stage Small Cell Lung Cancer

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What is being tested

Immuno-chemotherapy

+ Radiotherapy

+ Consolidative therapy

DrugRadiation
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

From 18 to 75 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorSun Yat-sen University
Study ContactDaQuan Wang, MD.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding better treatment options for patients with limited-stage small cell lung cancer (SCLC). It explores the combination of chemotherapy and a dual immune therapy approach, which includes drugs that help the body's immune system fight cancer cells more effectively. The study also includes radiotherapy as part of the treatment. By testing this new combination, the researchers aim to determine how effective and safe it is, potentially offering new hope for improved outcomes in managing this type of lung cancer. Participants in the study will undergo a treatment plan that includes chemotherapy with etoposide and platinum-based drugs, paired with immune therapies known as PD-1 and CTLA-4 inhibitors, along with thymosin alpha 1. This treatment cycle is repeated four times. Additionally, radiation therapy to the chest is given early in the treatment process. For patients who show a positive response, preventive brain radiation might be suggested. After these steps, participants continue with immune therapy and thymosin alpha 1 as part of a year-long consolidation treatment, which helps to sustain the benefits of the initial therapy.

Official TitleA Phase II Study Evaluating Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade (PD-1/CTLA-4) for Limited-stage Small Cell Lung Cancer
NCT07103408
Principal SponsorSun Yat-sen University
Study ContactDaQuan Wang, MD.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsSmall Cell Lung Carcinoma

Criteria

16 inclusion criteria required to participate
Males or females aged 18 to 75 years or older;

Patients must have histologically or cytologically confirmed small cell lung cancer (SCLC);

Stage II-III according to AJCC 8th staging system;

No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;

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12 exclusion criteria prevent from participating
Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;

Mixed small cell and non-small cell lung cancer histology;

Prior use of anti-PD-1, anti-PD-L1, or anti-CTLA4 antibodies;

Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients will receive chemotherapy (etoposide and platinum-based drugs) combined with dual immune checkpoint blockade (iparomlimab and tuvonralimab) and thymosin alpha 1, with a total cycles of 4. Thoracic radiotherapy was performed no later than the three cycle of chemotherapy. Prophylactic cranial irradiation was recommended for patients who received complete response or partial response after chemoradiotherapy. Finally consolidation therapy with dual immune checkpoint blockade (iparomlimab and tuvonralimab) and thymosin alpha 1 was conducted for one year.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sun Yat-sen University Cancer Center

Guangzhou, ChinaOpen Sun Yat-sen University Cancer Center in Google Maps
Recruiting soonOne Study Center