Radiosensitivity-guided personalized adaptive radiotherapy for locally advanced non-small cell lung cancer
Official title: Phase II/III Randomized Clinical Trial of Radiosensitivity-Assisted Personalized Adaptive RadioTherapy (RAPART) in Locally Advanced Non-small Cell Lung Cancer Patients
Run by Capital Medical University · NCT07164885 · Data updated 2026-11-12
This trial will test whether a radiosensitivity-guided personalized adaptive radiotherapy approach (RAPART) can improve survival for adults with unresectable locally advanced non-small cell lung cancer compared with standard 60 Gy radiotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 911 (estimated) |
| Sponsor | Capital Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Shenzhen, Guangdong) |
| Status | Recruiting |
| Started | February 17, 2025 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07164885 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with pathologically confirmed unresectable stage III non-small cell lung cancer and ECOG performance status 0–2, including those who have received prior surgery, chemotherapy, immunotherapy, or targeted therapy, are eligible.
✕Probably not a fit
Patients with contraindications to radiation therapy, those not suitable for close clinical follow-up (such as incarcerated individuals), or those with resectable disease or ECOG >2 are not expected to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized Phase II/III trial comparing Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology (RAPART) against conventional 60 Gy radiotherapy in unresectable stage III non-small cell lung cancer. RAPART uses radiosensitivity information to tailor radiation planning and adapt treatment over time, and participants may receive standard or mixed treatment combinations according to protocol. Primary outcomes include overall survival, progression-free survival, and local progression-free survival, with inclusion of patients who have had prior surgery, chemotherapy, immunotherapy, or targeted therapy. The trial is conducted at University of Hong Kong Shenzhen Hospital and enrolls adults with ECOG 0-2.
Why it matters
Potential benefit: If successful, RAPART could increase overall and progression-free survival and improve local tumor control by tailoring radiation to tumor radiosensitivity while potentially limiting normal-tissue toxicity.
How similar studies have gone: Adaptive and biologically guided radiotherapy approaches have shown promising signals in early-phase studies, but large randomized phase III evidence for radiosensitivity-guided personalization in stage III NSCLC is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult research participants, aged over 18 years old; * Non small cell lung cancer that requires pathological confirmation; * All stage 3 unresectable non-small cell lung cancer, including stage correction after MDT and stage downgrading after treatment (4 → 3), and stage upregulation due to disease progression (2 → 3); * ECOG physical condition is 0-2; * In addition to study participants who have not received any treatment, study participants who have undergone surgery, chemotherapy, immunotherapy, and targeted therapy are also eligible for enrollment. Exclusion Criteria: * Prisoners who are not convenient for close clinical follow-up; * Study participants with contraindications to radiation therapy.
Where it's running
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University of Hong Kong Shenzhen Hospital
Shenzhen, Guangdong, China Recruiting
Study contacts
- Study coordinator: Feng-Ming (Spring) Kong
- Email: kong0001@hku.hk
- Phone: +86 188 0755 0703
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.