RAPART in Locally Advanced Non-small Cell Lung Cancer Patients

NCT07164885 | Recruiting

• 1 other identifier: GCOG0058
• Study Type: interventional
• Target: 911
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II/III randomized clinical trial of Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology (RAPART) in locally advanced non-small cell lung cancer patients. The main objective is to test the overall improvement of overall survival (OS), progression free survival (PFS), and local progression free survival (LPFS) of unresectable stage III NSCLC under standard and non-standard mixed treatment conditions compared to conventional 60Gy radiotherapy.

Conditions

Locally Advanced Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (2)

• progression-free survival

  From enrollment to 3 years after the end of treatment

• Toxic events

  From enrollment to 3 years after treatment

Study Arms (2)

Experiment

EXPERIMENTAL

RAPART technology

Radiation: Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology（RAPART)）

conventional radiotherapy

ACTIVE COMPARATOR

conventional radiotherapy 2Gy/F

Radiation: Conventional radiotherapy

Interventions

Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology（RAPART)） RADIATION

RAPART technology is a special combination of ART and RAPRT, with a total course limit of no more than 30 exposures. The entire course of treatment can be divided into two stages: the first stage is completely the same as the conventional radiotherapy group, with a total of 23 doses of 2 Gy per session. The second stage is the combination of ART and PAPRT. ART uses a CT or PET/CT localization simulation to be performed again during the course of treatment (usually after completing the first part of 17-19 exposures) to generate a new adaptive plan, and after completing the first stage of 23 exposures, treatment is carried out according to the new adaptive plan. RAPAT uses ERCC1/2 biomarkers to predict the patient's radiation sensitivity and determine individualized radiation dose accordingly. ERCC1/2 biomarkers divided patients into 5 different radiosensitivity groups, corresponding to 5 different radiation doses (74, 66, 62, 54, and 50 Gy).

Experiment

Conventional radiotherapy RADIATION

conventional radiotherapy

conventional radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prisoners who are not convenient for close clinical follow-up;
• Study participants with contraindications to radiation therapy.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

University of Hong Kong Shenzhen Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

Central Study Contacts

Feng-Ming (Spring) Kong

CONTACT

+86 188 0755 0703; kong0001@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: September 10, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)