A Study Evaluating Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade for Limited-stage Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2029-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will enroll patients with limited-stage small cell lung cancer (SCLC). Patients will receive chemotherapy (etoposide and platinum-based drugs) combined with dual immune checkpoint blockade (PD-1/CTLA-4) 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 (PD-1/CTLA-4) and thymosin alpha 1 was conducted for one year. The study aims to evaluate the efficacy and safety of this treatment regimen.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer

NCT07103395

Lung Cancer (NSCLC)

RECRUITING PHASE2

Study of Split-course Chemoradiotherapy For Locally Advanced None-small Cell Lung Cancer

NCT02573506

Non-small Cell Lung Cancer

COMPLETED PHASE2

Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for Locally Advanced Non-small Cell Lung Cancer

NCT06734702

Neoadjuvant Therapy Concurrent Chemoradiotherapy Immunotherapy +1 more

RECRUITING PHASE3

Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer

NCT07086456

Surufatinib Tislelizumab Concurrent Chemoradiotherapy +2 more

RECRUITING PHASE2

Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer

NCT06719700

Toripalimab Surufatinib Chemoradiotherapy +1 more

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Small-Cell Lung Cancer (SCLC)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The study group

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.

Group Type EXPERIMENTAL

Immuno-chemotherapy

Intervention Type DRUG

Immuno-chemotherapy regimen included etoposide, cisplatin, iparomlimab and tuvonralimab, and thymosin alpha 1.

Radiotherapy

Intervention Type RADIATION

Definitive dose of thoracic radiotherapy was delivered no later than the three cycle of immuno-chemotherapy.

Prophylactic cranial irradiation (PCI) was delivered with a total dose of 25Gy in 10 fractions. PCI was recommended for patients who achieved complete response or partial response after thoracic chemoradiotherapy.

Consolidative therapy

Intervention Type DRUG

Consolidation therapy regimen included iparomlimab and tuvonralimab, and thymosin alpha 1, with a duration of one year.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Immuno-chemotherapy

Immuno-chemotherapy regimen included etoposide, cisplatin, iparomlimab and tuvonralimab, and thymosin alpha 1.

Intervention Type DRUG

Radiotherapy

Definitive dose of thoracic radiotherapy was delivered no later than the three cycle of immuno-chemotherapy.

Prophylactic cranial irradiation (PCI) was delivered with a total dose of 25Gy in 10 fractions. PCI was recommended for patients who achieved complete response or partial response after thoracic chemoradiotherapy.

Intervention Type RADIATION

Consolidative therapy

Consolidation therapy regimen included iparomlimab and tuvonralimab, and thymosin alpha 1, with a duration of one year.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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;
* Expected survival ≥ 12 weeks;
* WHO Performance Status (PS) score of 0 or 1;
* Female subjects must not be breastfeeding;
* Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment and for 5 months after the last dose of study drug (i.e., 30 days \[one ovulation cycle\] plus approximately five half-lives of the study drug);
* Adequate organ and bone marrow function as defined by the following criteria:
* Forced Expiratory Volume in 1 second (FEV1) ≥ 800 mL;
* Absolute neutrophil count ≥ 1.5 × 10⁹/L;
* Platelets ≥ 100 × 10⁹/L;
* Hemoglobin ≥ 9.0 g/dL;
* Creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976);
* Serum bilirubin ≤ 1.5 × upper limit of normal (ULN);
* AST and ALT ≤ 2.5 × ULN.

Exclusion Criteria

* 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;
* Active or prior documented autoimmune disease within the past 2 years;
* Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);
* History of primary immunodeficiency;
* History of organ transplant that requires therapeutic immunosuppression;
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent;
* Known history of tuberculosis;
* History of another primary malignancy within 5 years prior to starting treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
* Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No