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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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 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

A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer (NCT07103395) is a Phase 2 interventional studying Lung Cancer (NSCLC), sponsored by Sun Yat-sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Lung Cancer (NSCLC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 56 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Lung Cancer (NSCLC) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Males or females aged 18 to 75 years or older; - Patients must have diagnosed by tissue sample (biopsy-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; - 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; - platelet count at least 100 × 10⁹/L; - blood count (hemoglobin) at least 9.0 g/dL; - kidney function (creatinine clearance) at least 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 Should NOT Join This Trial: 1. 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 conditions (where your immune system attacks your own body) within the past 2 years; - Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis); - History of primary weakened immune system; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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; * 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: 1. 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; * 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. 2. 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. 3. 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.

Treatments Being Tested

DRUG

Neoadjuvant therapy

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

RADIATION

Radiotherapy

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

DRUG

Consolidative therapy

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07103395), the sponsor (Sun Yat-sen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07103395 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07103395?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07103395?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07103395. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07103395. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.