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Trial · Interventional

Not yet recruitingPhase 2Registry data

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

This trial does not test a peptide that PepBank tracks.

  • Names Thymosin alpha-1, does not test it. It appears in the summary.

Overview

Status
Not yet recruiting
Phase
Phase 2
Enrollment
56 participants (estimated)
Sponsor
Sun Yat-sen University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
1 Oct 2025 (estimated)
Primary completion
30 Sept 2029 (estimated)
Completion
30 Sept 2029 (estimated)
First posted
5 Aug 2025
Last update posted
5 Aug 2025
Conditions
Small-Cell Lung Cancer (SCLC)

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027202820292030
  1. Ph 2

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

    NCT07103408

    est. 1 Oct 2025 to est. 30 Sept 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Immuno-chemotherapyDrug
  • RadiotherapyRadiation
  • Consolidative therapyDrug

Arms1

  • Experimental

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Progression-free survival

    Time frame · 2-year

    Registry description

    PFS measures the time from the start date of treatment to disease progression, death from any cause or last follow up if alive.

Secondary outcomes(2)
  1. Overall survival

    Time frame · 2-year

    Registry description

    OS measures the time from the start date of treatment to death from any cause or last follow up if alive.

  2. Treatment-related toxicity

    Time frame · through study completion, an average of 18 months

    Registry description

    Treatment-related toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 5.0 toxicity

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Review · 2012

1 result

Thymosin α1 and cancer: action on immune effector and tumor target cells.

Garaci et al. 2012Annals of the New York Academy of Sciencescited by 62

PMID 23045967DOI 10.1111/j.1749-6632.2012.06697.xPUB-23045967

Full text at the publisher1 result

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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