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Immunotherapy plus chemo and radiation: new hope for lung cancer?

NCT ID NCT07138755

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This phase 2 trial tests whether adding the immunotherapy drug sintilimab to standard chemotherapy and a tailored radiation plan can help people with stage III non-small cell lung cancer. The study will enroll 35 adults who cannot have surgery. Researchers will track how long the cancer stays under control and any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sintilimab (an immunotherapy drug) combined with platinum-based chemotherapy (cisplatin or carboplatin plus paclitaxel or pemetrexed) and adaptive radiotherapy
What this could lead to
If successful, this combination could improve control of stage III lung cancer and delay disease progression, offering a new treatment option.
What could go wrong
This is a small, early-phase trial with only 35 participants, so results may not apply broadly. Side effects from the drug combination and radiation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study 2. Age range of 18-75 years old upon enrollment, both male and female are eligible 3. 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) 4. It was clarified that surgical resection is not possible After MDT discussion, 5. The main driver genes have no sensitive mutations (including EGFR, ALK, ROS1, MET, HER2, etc.) 6. No previous systematic anti-tumor treatment or chest radiotherapy for NSCLC 7. 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 8. There is sufficient organ function reserve to meet the needs of clinical research Exclusion Criteria: 1. There are any small cell carcinoma components present in the histopathology, as well as special types such as salivary gland type and SMARCA4 deficiency 2. 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 3. Previously received local treatments for tumor lesions such as thoracic radiotherapy and radiofrequency ablation 4. 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 5. Suffering from active autoimmune diseases that require systematic treatment within the past two years 6. History of immunodeficiency; Individuals who test positive for HIV antibodies; Currently in long-term use of systemic corticosteroids or other immunosuppressants 7. 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 8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 9. Previous or current non infectious pneumonia/interstitial lung disease requiring systemic corticosteroid therapy 10. 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) 11. Current active hepatitis B subjects (HBsAg positive and HBV-DNA exceeding 1000 copies/ml (200IU/ml) or above the detection limit) 12. 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 13. History of myocarditis, cardiomyopathy, and malignant arrhythmia in the past 14. 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 15. 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 16. History of severe bleeding tendency or coagulation dysfunction 17. Received a live vaccine within 30 days prior to the first administration, or planned to receive a live vaccine during the study period 18. Known to be allergic to any component of any anti-tumor drug; Known history of severe hypersensitivity reactions to other monoclonal antibodies 19. Known history of mental illness, drug abuse, alcoholism, or drug use 20. Pregnant or lactating women 21. 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 22. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410013, China

  • The First Affiliated Hospital of Nanhua University

    RECRUITING

    Hengyang, Hunan, China

  • Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital

    RECRUITING

    Jishou, Hunan, 416000, China

  • Xiangya 3rd Hospital, Central South University

    RECRUITING

    Changsha, Hunan, 410013, China

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