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Not yet recruitingNCT07103408Updated Aug 5, 2025

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

A Phase 2 interventional study of Immuno-chemotherapy and Radiotherapy in Small-Cell Lung Cancer (SCLC), sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Small-Cell Lung Cancer (SCLC)
03

In context

Small Cell Lung Carcinoma

1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 340 are open to participants now.

This study's planned enrollment of 56 is close to the median of 56 across 1,030 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • 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.

    Drug: Immuno-chemotherapy · Radiation: Radiotherapy · Drug: Consolidative therapy

Interventions

  • DrugImmuno-chemotherapy

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

  • RadiationRadiotherapy

    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.

  • DrugConsolidative therapy

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

06

What researchers measure

Primary outcomes

  1. Progression-free survival

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

    Time frame: 2-year

Secondary outcomes

  1. Overall survival

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

    Time frame: 2-year

  2. Treatment-related toxicity

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

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

07

Study locations

1 site
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510000, China
08

References and documents

Publications

  • Garaci E, Pica F, Serafino A, Balestrieri E, Matteucci C, Moroni G, Sorrentino R, Zonfrillo M, Pierimarchi P, Sinibaldi-Vallebona P. Thymosin alpha1 and cancer: action on immune effector and tumor target cells. Ann N Y Acad Sci. 2012 Oct;1269:26-33. doi: 10.1111/j.1749-6632.2012.06697.x. PubMed 23045967 ↗
  • Malhotra J, Chiappori A, Fujioka N, Hanna NH, Feldman LE, Patel M, Moore D, Chen C, Jabbour SK. Phase I/II trial of plinabulin in combination with nivolumab and ipilimumab in patients with recurrent small cell lung cancer (SCLC): Big ten cancer research consortium (BTCRC-LUN17-127) study. Lung Cancer. 2024 Sep;195:107932. doi: 10.1016/j.lungcan.2024.107932. Epub 2024 Aug 21. PubMed 39173229 ↗
  • Huang Y, Yang Y, Zhao Y, Zhao H, Zhou N, Zhang Y, Chen L, Zhou T, Chen G, Wu T, Lu L, Xue S, Kang X, Zhang L, Fang W. QL1706 (anti-PD-1 IgG4/CTLA-4 antibody) plus chemotherapy with or without bevacizumab in advanced non-small cell lung cancer: a multi-cohort, phase II study. Signal Transduct Target Ther. 2024 Jan 29;9(1):23. doi: 10.1038/s41392-023-01731-x. PubMed 38282003 ↗
  • Cheng W, Kang K, Zhao A, Wu Y. Dual blockade immunotherapy targeting PD-1/PD-L1 and CTLA-4 in lung cancer. J Hematol Oncol. 2024 Jul 27;17(1):54. doi: 10.1186/s13045-024-01581-2. PubMed 39068460 ↗
  • Duan H, Shi L, Shao C, Wang Y, Wang Z, Ni Y, Zhao J, Sun J, Tong L, Lei J, Jiang T, Liu Z, Yan X. A multicenter, single-arm, open study of neoadjuvant or conversion atezolizumab in combination with chemotherapy in resectable small cell lung cancer (Cohort Study). Int J Surg. 2023 Sep 1;109(9):2641-2649. doi: 10.1097/JS9.0000000000000501. PubMed 37428211 ↗
  • Cheng Y, Spigel DR, Cho BC, Laktionov KK, Fang J, Chen Y, Zenke Y, Lee KH, Wang Q, Navarro A, Bernabe R, Buchmeier EL, Chang JW, Shiraishi Y, Sezgin Goksu S, Badzio A, Shi A, Daniel DB, Hoa NTT, Zemanova M, Mann H, Gowda H, Jiang H, Senan S; ADRIATIC Investigators. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med. 2024 Oct 10;391(14):1313-1327. doi: 10.1056/NEJMoa2404873. Epub 2024 Sep 13. PubMed 39268857 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07103408
Lead sponsor
Sun Yat-sen University
Responsible party
Hui Liu (Professor, Sun Yat-sen University) — Principal investigator
First posted
Aug 5, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Sep 30, 2029 (estimated)
Completion
Sep 30, 2029 (estimated)
Last update
Aug 5, 2025

Study contacts

DaQuan Wang, MD.
Contact
wangdq@sysucc.org.cn
+862087343031

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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