Not yet recruitingNCT07874464Updated Oct 14, 2026

Prospective Phase II Study of Concurrent Radiotherapy Combined With Full-Course Immunotherapy or Consolidation Immunotherapy for Locally Advanced NSCLC

A Phase 2 interventional study of Induction chemoimmunotherapy and radiotherapy in Lung Cancer (NSCLC), 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 2026-10-14.

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

Updated Oct 14, 2026Newly registeredGo to Updates ↓

Phase: Phase 2
Study type: Interventional
Enrollment: 256
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

This is a prospective, randomized phase II study evaluating concurrent chemoradiotherapy combined with full-course immunotherapy or consolidative immunotherapy in patients with unresectable, locally advanced non-small cell lung cancer.

Read the detailed description

This is a prospective, randomized phase II study evaluating concurrent chemoradiotherapy combined with full-course immunotherapy or consolidative immunotherapy in unresectable, locally advanced non-small cell lung cancer. Patients are randomized in a 1:1 ratio to experimental group and control group. The experimental group will receive induction chemoimmunotherapy, concurrent chemoradiotherapy, and full-course immunotherapy during the chemoradiotherapy phase and consolidation phase. Patients in the control group will receive concurrent chemoradiotherapy and consolidative immunotherapy.

Conditions studied

Lung Cancer (NSCLC)

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Keywords

Unresectable Locally Advanced Non-Small Cell Lung Cancer
Induction Chemoimmunotherapy
Hypofractionated Concurrent Chemoradiotherapy
Tislelizumab

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's planned enrollment of 256 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Browse Sun Yat-sen University studies →

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

Who can participate

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

Eligibility criteria

Inclusion Criteria:

Male or female patients aged 18-75 years ;
Histologically or cytologically confirmed, locally advanced, unresectable stage III non-small cell lung cancer (NSCLC);
Wild-type EGFR, ALK, and ROS1;
No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;
Availability of unstained archival tumor tissue samples sufficient for analysis;
Life expectancy of ≥12 weeks;
World Health Organization (WHO) performance status of 0 or 1;
Female patients must not be breastfeeding;
Adequate organ and bone marrow function, meeting all of the following criteria: Forced expiratory volume in 1 second (FEV1) ≥800 mL; Absolute neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥9.0 g/dL; Creatinine clearance ≥50 mL/min, calculated using the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Serum bilirubin ≤1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN.

Exclusion Criteria:

Exclusion Criteria for Induction Therapy:

Patients meeting any of the following criteria will not receive induction therapy:

Concurrent participation in another clinical study, unless it is an observational, non-interventional study;
Mixed small cell and non-small cell lung cancer histology;
Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody;
Major surgery within 4 weeks before study entry, excluding procedures for vascular access;
Active autoimmune disease or a history of autoimmune disease within the past 2 years;
Active inflammatory bowel disease or a history of inflammatory bowel disease, such as Crohn's disease or ulcerative colitis;
History of primary immunodeficiency;
History of organ transplantation requiring immunosuppressive therapy;
Uncontrolled intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, cardiac arrhythmia, active peptic ulcer disease or gastritis, or active bleeding disorders; known hepatitis B surface antigen (HBsAg) positivity with HBV DNA >500 IU/mL, hepatitis C, or human immunodeficiency virus (HIV) infection; or psychiatric illness or social circumstances that would limit compliance with study requirements or impair the ability to provide written informed consent;
Known history of tuberculosis, except for old, inactive pulmonary tuberculosis;
History of another primary malignancy within the past 5 years, except adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;
Pregnancy or breastfeeding; or male or female patients of reproductive potential who are not using effective contraception.

Exclusion Criteria for Concurrent Chemoradiotherapy After Induction Therapy:

Patients meeting any of the following criteria will not proceed to concurrent chemoradiotherapy:
Development of distant metastases;
Locoregional disease progression that, in the judgment of the radiation oncologist, precludes definitive chemoradiotherapy because normal tissue dose constraints cannot be met;
WHO performance status of 2-4;
Any of the following organ or bone marrow impairments: FEV1 \<800 mL; Absolute neutrophil count \<1.5 × 10⁹/L; Platelet count \<100 × 10⁹/L; Hemoglobin \<9.0 g/dL; Creatinine clearance \<50 mL/min, calculated using the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Serum bilirubin >1.5 times ULN; AST and ALT >2.5 times ULN.

Exclusion Criteria for Consolidation Immunotherapy After Concurrent Chemoradiotherapy:

Patients meeting any of the following criteria will not proceed to consolidation immunotherapy:
Disease progression during concurrent chemoradiotherapy;
Use of immunosuppressive medication within 28 days before the first dose of dual immunotherapy, except for intranasal or inhaled corticosteroids at physiological doses, or systemic corticosteroids at doses not exceeding 10 mg/day of prednisone or equivalent. Corticosteroids used to manage chemoradiotherapy-related toxicity are permitted;
Unresolved toxicity of CTCAE grade >2 from prior chemoradiotherapy;
Grade ≥2 pneumonitis resulting from prior chemoradiotherapy;
Any previous grade ≥3 immune-related adverse event (irAE), or any unresolved irAE of grade >1.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 256 participants (estimated)

Study arms

Experimental
The experimental group
Patients are planned to receive induction chemoimmunotherapy, concurrent chemoradiotherapy, and full-course immunotherapy during concurrent chemoradiotherapy phase and consolidation phase.
Drug: Induction chemoimmunotherapy · Radiation: radiotherapy · Drug: Concurrent Chemotherapy · Drug: consolidation immunotherapy · Drug: full-course immunotherapy
Active comparator
The control group
Patients are planned to receive concurrent chemoradiotherapy and then consolidation immunotherapy.
Radiation: radiotherapy · Drug: Concurrent Chemotherapy · Drug: consolidation immunotherapy

Interventions

DrugInduction chemoimmunotherapy
Nab-paclitaxel 260 mg/m² + cisplatin 75 mg/m² + tislelizumab 200 mg on day 1, Q3W，3 cycles.
Radiationradiotherapy
Thoracic radiotherapy at a definitive dose using intensity-modulated radiation therapy or Volumetric Modulated Arc Therapy.
DrugConcurrent Chemotherapy
Nab-paclitaxel 50 mg/m² + cisplatin 25 mg/m² on day 1, weekly.
Drugconsolidation immunotherapy
Tislelizumab 200 mg on day 1, every 3 weeks.
Drugfull-course immunotherapy
Immunotherapy (Tislelizumab 200 mg d1) will be administered during the concurrent chemoradiotherapy phase and consolidation phase, but not on radiotherapy days.

What researchers measure

Primary outcomes

Progression free survival rate
From the first day of treatment to the day of progression or the day of death.
Time frame: 18 months

Secondary outcomes

Overall survival
It was calculated from the first day of treatment to the day of death.
Time frame: 18 months
Objective response rate
The proportion of patients evaluated as CR or PR
Time frame: 1 year
Incidence of Treatment-related Adverse Events
Adverse effects are graded according to the CTCAE 5.0 version.
Time frame: 1 year

Study locations

1 site

Sun yat-sen University Cancer Center
Guangzhou, Guangdong 510060, China
- Bo Qiu · Contact · qiubo@sysucc.org.cn · +86-020-87343031

References and documents

Publications

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 ↗
Yang X, Yin R, Xu L. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 Aug 30;379(9):e14. doi: 10.1056/NEJMc1808251. No abstract available. PubMed 30179394 ↗
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 ↗
Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8. PubMed 28885881 ↗
Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16. PubMed 25601342 ↗
Machtay M, Bae K, Movsas B, Paulus R, Gore EM, Komaki R, Albain K, Sause WT, Curran WJ. Higher biologically effective dose of radiotherapy is associated with improved outcomes for locally advanced non-small cell lung carcinoma treated with chemoradiation: an analysis of the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):425-34. doi: 10.1016/j.ijrobp.2010.09.004. Epub 2010 Oct 25. PubMed 20980108 ↗
Bi N, Wang L. Superiority of concomitant chemoradiation over sequential chemoradiation in inoperable, locally advanced non-small cell lung cancer: challenges in the selection of appropriate chemotherapy. Semin Radiat Oncol. 2015 Apr;25(2):122-32. doi: 10.1016/j.semradonc.2014.11.003. Epub 2014 Nov 18. PubMed 25771417 ↗
Bezjak A, Temin S, Franklin G, Giaccone G, Govindan R, Johnson ML, Rimner A, Schneider BJ, Strawn J, Azzoli CG. Definitive and Adjuvant Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Society for Radiation Oncology Evidence-Based Clinical Practice Guideline. J Clin Oncol. 2015 Jun 20;33(18):2100-5. doi: 10.1200/JCO.2014.59.2360. Epub 2015 May 5. PubMed 25944914 ↗

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.

Of 535 non-industry phase 2 interventional studies under Lung Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 86. This study's planned 24 months is below that.

Counting every sponsor, half of 712 studies reached it within 46 months; a quarter within 30 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 8, 2026
First posted: Oct 14, 2026
StartEst.: Oct 12, 2026
Primary completionEst.: Oct 12, 2028
CompletionEst.: Oct 12, 2029
Last update: Oct 14, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 14, 2026

Show all 1 update

Oct 14, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07874464
Lead sponsor: Sun Yat-sen University
Responsible party: Hui Liu (Professor, Sun Yat-sen University) — Principal investigator
First posted: Oct 14, 2026
Start date: Oct 12, 2026 (estimated)
Primary completion: Oct 12, 2028 (estimated)
Completion: Oct 12, 2029 (estimated)
Last update: Oct 14, 2026

Study contacts

DaQuan Wang

Contact

wangdq@sysucc.org.cn

+862087343031

Hui Liu

Contact

liuhui@sysucc.org.cn

+862087343031

Hui Liu

principal investigator · Sun Yat-Sen University Cancer Center

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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