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Radiation boosts immunotherapy in lung cancer trial

NCT ID NCT06121505

Disease control Sponsor: Sichuan University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 2 trial tests whether adding low-dose radiation to standard immunotherapy (sintilimab) and chemotherapy can shrink tumors better than immunotherapy and chemo alone in people with advanced squamous cell lung cancer. About 114 participants will be randomly assigned to one of two groups. The study is currently recruiting.

What this could mean

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

Active substance
sintilimab (PD-1 inhibitor) plus chemotherapy, with low-dose radiation therapy and stereotactic body radiation therapy
What this could lead to
If it works, this could offer a more effective first-line treatment for advanced squamous cell lung cancer by combining radiation with immunotherapy and chemo.
What could go wrong
This is a small, early-phase (Phase 2) trial with only 114 participants. Adding radiation may increase side effects, and the benefit over standard treatment is not yet proven.

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 114 people

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

Started

Mar 2024

Expected to finish

Feb 2027

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. Age ≥ 18 years old and ≤ 75 years old; 2. Histologically or cytologically confirmed squamous cell lung cancer, imaging confirmed locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV); 3. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one imaging measurable lesion; 4. Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression; 5. Have not received any systemic anti-tumor treatment for locally advanced or metastatic disease in the past; Exclusion Criteria: 1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)； 2. The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma and lung squamous cell carcinoma; 3. EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive; 4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors; 5. Pregnant or lactating women;

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Conditions

The condition(s) this trial relates to.

squamous cell lung carcinoma

As listed by the trial registrant

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

Lung squamous cell carcinoma

How to take part

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

  1. The places running it

    6 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

  • Affiliated Hospital of North Sichuan Medical College

    RECRUITING

    Nanchong, Sichuan, 637503, China

  • Guizhou Provincial People's Hospital

    RECRUITING

    Guiyang, Guizhou, 550002, China

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, Sichuan, 610044, China

  • The Second Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400010, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hunan, 430022, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610044, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.