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Lung Cancer (NSCLC)Phase 2NCT07103395

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

A Phase 2 study testing Neoadjuvant therapy, Radiotherapy and Consolidative therapy in people with Lung Cancer (NSCLC), run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will enroll patients with locally advanced non-small cell lung cancer (NSCLC). Patients will receive neoadjuvant chemotherapy combined with dual immune checkpoint blockade (PD-1/CTLA-4), bevacizumab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with dual… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Cancer (NSCLC)
What is being tested?
Neoadjuvant therapy, Radiotherapy and Consolidative therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
1 Jan 2026to 30 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females aged 18 to 75 years or older;
  • Patients must have histologically or cytologically confirmed locally advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC);
  • EGFR, ALK, and ROS1 wild-type;
  • No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;
  • Expected survival ≥ 12 weeks;
  • WHO Performance Status (PS) score of 0 or 1;
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  • 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.

Who cannot join

  • Exclusion criteria for enrolment for neoadjuvant therapy. Patients should not enter the study if any of the following exclusion criteria are fulfilled:
  • 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;
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  • 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.
  • Exclusion criteria for concurrent chemoradiation following neoadjuvant therapy. Patients should not enter the concurrent chemoradiation phase if any of the following exclusion criteria are fulfilled:
  • Patients who develop distant metastasis;
  • Patients who develop locoregional disease progression and the irradiation dose of normal tissue will exceed the limit.
  • World Health Organization (WHO) Performance Status of 2-4;
  • Inadequate organ and marrow function as defined below:
  • Forced expiratory volume in 1 second (FEV1) <800ml
  • Absolute neutrophil count <1.5 x 109/L (1500 per mm3)
  • Platelets <100 x 109/L (100,000 per mm3)
  • Haemoglobin<9.0 g/dL (5.59 mmol/L)
  • Serum creatinine CL <50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976)
  • Serum bilirubin >1.5 x upper limit of normal (ULN).
  • Aspartate Transaminase(AST) and Alanine Transaminase(ALT) >2.5 x ULN.
  • Further exclusion criteria for consolidation therapy. Patients should not enter the consolidation therapy if any of the following exclusion criteria are fulfilled:
  • Patients who have progressed whilst definitive platinum based, concurrent chemoradiation therapy;
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of Iparomlimab and tuvonralimab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.
  • Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy will be excluded from randomization;
  • Patients with Grade ≥2 pneumonitis from prior chemoradiation therapy will be excluded from randomization;
  • Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE>Grade 1.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

DaQuan Wang, MD. contact

+862087343031

wangdq@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Hui Liu, Doctor, liuhuisysucc@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase II Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade (PD-1/CTLA-4) in Patients With Locally Advanced Non-Small Cell Lung Cancer

This study will enroll patients with locally advanced non-small cell lung cancer (NSCLC). Patients will receive neoadjuvant chemotherapy combined with dual immune checkpoint blockade (PD-1/CTLA-4), bevacizumab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with dual immune checkpoint blockade (PD-1/CTLA-4), surufatinib and thymosin alpha 1. The study aims to evaluate the efficacy and safety of this treatment regimen.

Being tested
Neoadjuvant therapy, Radiotherapy, Consolidative therapy
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant therapyDrug

    The neoadjuvant regimen prior to radiotherapy consists of albumin-bound paclitaxel/pemetrexed, cisplatin, Bevacizumab, iparomlimab and tuvonralimab, and thymosin alpha 1.

  • RadiotherapyRadiation

    Definitive dose of hypofractionated radiotherapy was delivered to patients, with concurrent chemotherapy and surufatinib.

  • Consolidative therapyDrug

    Consolidation therapy consists of iparomlimab and tuvonralimab, surufatinib and thymosin alpha 1, for a total duration of 1 year.

Study groups in NCT07103395
Study groupRoleWhat they receive
The study groupExperimentalPatients will receive neoadjuvant chemotherapy combined with iparomlimab and tuvonralimab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with iparomlimab and tuvonralimab and thymosin alpha 1.
Receives: Drug: Neoadjuvant therapy; Radiation: Radiotherapy; Drug: Consolidative therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2-year

Secondary outcomes (3)

  1. Objective response rate

    Measured: 2 month after treatment

  2. Overall survival

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

    Measured: 2-year

  3. Treatment-related toxicity

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

    Measured: through study completion, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start1 Jan 2026
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07103395
Sponsor's protocol ID
GASTO-10135
Status last verified
Jan 2026
First submitted
16 Jul 2025
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Danielli R, Cisternino F, Giannarelli D, Calabro L, Camerini R, Savelli V, Bova G, Dragonetti R, Di Giacomo AM, Altomonte M, Maio M. Long-term follow up of metastatic melanoma patients treated with Thymosin alpha-1: investigating immune checkpoints synergy. Expert Opin Biol Ther. 2018 Jul;18(sup1):77-83. doi: 10.1080/14712598.2018.1494717.

    PubMed 30063847

  • Garaci E, Pica F, Rasi G, Favalli C. Thymosin alpha 1 in the treatment of cancer: from basic research to clinical application. Int J Immunopharmacol. 2000 Dec;22(12):1067-76. doi: 10.1016/s0192-0561(00)00075-8.

    PubMed 11137613

  • 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

  • Provencio M, Nadal E, Insa A, Garcia-Campelo MR, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Anton C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermudez A. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24.

    PubMed 32979984

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant therapy, Radiotherapy and Consolidative therapy in people with Lung Cancer (NSCLC), run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact DaQuan Wang, MD. (+862087343031, wangdq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 2-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07103395, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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