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NSCLCPhase 2NCT07138755

The Efficacy and Safety of the Combination of PD-1 With Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients

A Phase 2 study testing Experimental in people with NSCLC and Sintilimab, run by The Third Xiangya Hospital of Central South University at 4 sites 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

To evaluate the Efficacy and Safety of the Combination of Sintilimab With Platinum-doublet Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC, Sintilimab, Adaptive Radiotherapy
What is being tested?
Experimental
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
4 sitesChina
Study dates
29 Aug 2025to Sep 2030
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

  • The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study
  • Age range of 18-75 years old upon enrollment, both male and female are eligible
  • Stage III NSCLC confirmed by histology or cytology (according to the International Union Against Cancer and the Joint American Committee on Cancer 8th edition TNM staging of lung cancer)
  • It was clarified that surgical resection is not possible After MDT discussion,
  • The main driver genes have no sensitive mutations (including EGFR, ALK, ROS1, MET, HER2, etc.)
  • No previous systematic anti-tumor treatment or chest radiotherapy for NSCLC
  • According to RECIST v1.1, there is at least one measurable lesion, and according to RECIST v1.1, this lesion is suitable for repeated and accurate measurements
  • There is sufficient organ function reserve to meet the needs of clinical research

Who cannot join

  • There are any small cell carcinoma components present in the histopathology, as well as special types such as salivary gland type and SMARCA4 deficiency
  • Except for NSCLC, the subjects had other malignant tumors within the 5 years prior to enrollment. Subjects with other tumors that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ, are not excluded
  • Previously received local treatments for tumor lesions such as thoracic radiotherapy and radiofrequency ablation
  • Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 1 week before the first administration
  • Suffering from active autoimmune diseases that require systematic treatment within the past two years
  • History of immunodeficiency; Individuals who test positive for HIV antibodies; Currently in long-term use of systemic corticosteroids or other immunosuppressants
Show all 22Show fewer
  • Subjects who are known to have active pulmonary tuberculosis (TB) and suspected of having TB need to undergo clinical examination to exclude them; Known active syphilis infection
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
  • Previous or current non infectious pneumonia/interstitial lung disease requiring systemic corticosteroid therapy
  • Serious infection occurred within 4 weeks prior to the first administration, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infections that have received systemic anti infective therapy within 2 weeks prior to the first administration (excluding antiviral therapy for hepatitis B or C)
  • Current active hepatitis B subjects (HBsAg positive and HBV-DNA exceeding 1000 copies/ml (200IU/ml) or above the detection limit)
  • Tumor invasion or compression of important surrounding organs (such as aorta, heart and pericardium, superior vena cava, trachea, esophagus, etc.) or the risk of developing esophagotracheal fistula or esophageal pleural fistula; Tumor mediastinal lymph node metastasis invading the trachea and main bronchus with the risk of bronchial fistula
  • History of myocarditis, cardiomyopathy, and malignant arrhythmia in the past
  • Within 6 months prior to the first administration, there is a history of esophageal and gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding
  • Any arterial thromboembolic event, NCI CTCAE 5.0 grade 3 or higher venous thromboembolic event, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy occurred within 6 months prior to the first administration; Currently, there is hypertension and after treatment with oral antihypertensive drugs, the systolic blood pressure is ≥ 160mmHg or the diastolic blood pressure is ≥ 100mmHg
  • History of severe bleeding tendency or coagulation dysfunction
  • Received a live vaccine within 30 days prior to the first administration, or planned to receive a live vaccine during the study period
  • Known to be allergic to any component of any anti-tumor drug; Known history of severe hypersensitivity reactions to other monoclonal antibodies
  • Known history of mental illness, drug abuse, alcoholism, or drug use
  • Pregnant or lactating women
  • Any past or current diseases, treatments, or laboratory abnormalities that may confuse the research results, affect the participants' full participation in the study, or may not be in the best interests of the participants
  • Local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risks and/or uncertainty in survival evaluation, such as tumor like leukemia reactions (white blood cell count>20 × 109/L), cachexia manifestations (such as known weight loss of more than 10% in the first 3 months of screening), etc

Trial locations and contacts

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

XueWen Liu contact

0731-88638888

603263@csu.edu.cn

China4 sites, 4 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Huai Liu, 0731-88651900, liuhuai@hnca.org.cn

    Recruiting

  • Xiangya 3rd Hospital, Central South University

    Changsha, Hunan, 410013

    Xuewen Liu Deputy Director, Department of Oncology and Director, Radiatio, Ph.D., +86 731 8863 8888, aveinliu@163.com

    Recruiting

  • The First Affiliated Hospital of Nanhua University

    Hengyang, Hunan

    Yuehua Li, 0734-8578745, liyuehua2020@stu.usc.edu.cn

    Recruiting

  • Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital

    Jishou, Hunan, 416000

    Jingsheng Zhao, 0743-8669668, 1007667189@qq.com

    Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of the Combination of Sintilimab With Platinum-doublet Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients

To evaluate the Efficacy and Safety of the Combination of Sintilimab With Platinum-doublet Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients

Being tested
Experimental
Keywords
V20, stage III NSCLC, Adaptive Radiotherapy, sintilimab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • ExperimentalDrug

    Drug: Sintilimab, 200mg IV D1 Q3W, Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5 D1 IV Q3W, Paclitaxel or Paclitaxel liposome 135-175mg/m2 D1 IV Q3W(Squamous） Drug: Sintilimab, 200mg IV D1 Q3W, Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5 D1 IV Q3W, Pemetrexed, 500mg/m2 D1 IV Q3W(adenocarcinoma） Radiation:Adaptive radiotherapy with V20<20%: 1.PGTV60-66Gy/2.0-2.2Gy/30F;PTV54Gy/1.8Gy/30F;2.PGTV54-66Gy/2.0-2.2Gy/30F；3.PGTV50Gy/2.0Gy/25F

Study groups in NCT07138755
Study groupRoleWhat they receive
adaptive radiotherapy strategyExperimentalAfter two cycles of sintilimab and platinum based chemotherapy, receive two additional courses of sintilimab and platinum based chemotherapy and adaptive radiotherapy strategy
Receives: Drug: Experimental

What is being measured

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

  1. Progression-Free Survival (PFS)

    The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause

    Measured: 28 months

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    the rate of patients with PR and CR

    Measured: 28 months

  2. Disease Control Rate (DCR)

    the rate of patients with PR and CR and SD

    Measured: 28 months

  3. Overall Survival (OS)

    The time from the beginning of treatment to the time when the patient dies from any cause

    Measured: 28 months

  4. Duration of response (DoR)

    Duration of Response (DoR) is defined as the time from the date of first documented objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the date of their last adequate tumor assessment.

    Measured: 28 months

  5. In-field local control rate

    In-field local control rate is defined as the proportion of participants without disease progression within the irradiated field, assessed according to RECIST version 1.1. In-field progression is defined as a ≥20% increase in the longest diameter of the target lesion relative to the smallest sum of diameters recorded since treatment initiation, or the appearance of a new malignant lesion within the radiation field or at its margin. The time to in-field local failure is measured from the start of radiotherapy to the date of documented in-field progression, death without in-field progression (censored), or last known follow-up (censored).

    Measured: 28 months

  6. Out-of-field recurrence rate

    Out-of-field recurrence rate is defined as the proportion of participants who develop disease recurrence or progression outside the Planning Target Volume (PTV). Out-of-field recurrence is defined as the appearance of a new lesion or progression (≥20% increase in the longest diameter relative to the smallest sum of diameters recorded since treatment initiation per RECIST version 1.1) at a site completely outside the PTV. The time to out-of-field recurrence is measured from the start of radiotherapy to the date of documented out-of-field recurrence, death without out-of-field recurrence (censored), or last known follow-up (censored).

    Measured: 28 month

  7. AE

    Incidence of Treatment-Emergent Adverse Events

    Measured: 28 months

Timeline

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

  1. First posted24 Aug 2025
  2. Study start29 Aug 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionSep 2030 (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
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07138755
Sponsor's protocol ID
R25063
Status last verified
Mar 2026
First submitted
24 Jul 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Wu L, Ma S, Zhang X, Song Z, Liu X. Single-arm, multicentre phase II trial of sintilimab plus platinum-based doublet chemotherapy followed by adaptive radiotherapy strategy for patients with unresectable stage III non-small-cell lung cancer in China: the ART-LUNG 01 study protocol. BMJ Open. 2026 Sep 29;16(9):e120335. doi: 10.1136/bmjopen-2026-120335.

    PubMed 42810785

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Experimental in people with NSCLC and Sintilimab, run by The Third Xiangya Hospital of Central South University at 4 sites 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 8 inclusion and 22 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 XueWen Liu (0731-88638888, 603263@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 28 months). 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 NCT07138755, which also lists 1 linked publication.

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 2 Sep 2026.

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