Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC). Radiotherapy strategies for maximizing efficacy and local control require further investigation. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of hypofractionated chemoradiotherapy followed by consolidative immunotherapy versus conventional fractionated chemoradiotherapy followed by consolidative immunotherapy in LANSCLC patients.
Eligibility criteria
Qualifiers
Signed and Dated Informed Consent: Written informed consent must be provided prior to any study procedures, with the consent form signed and dated by the participant.
Age Range: Male or female patients aged 18 to 75 years.
Diagnosis: Patients must have locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), with histological or cytological confirmation of the diagnosis.
Previous Treatment: Treatment-naïve or previously treated with induction chemotherapy ± immunotherapy.
Disqualifiers
Concurrent participation in another clinical trial, except for observational (non-interventional) studies.
Histological subtype of mixed small-cell and non-small-cell lung cancer. Use of immunosuppressive drugs within 28 days before treatment, except for intranasal or inhaled corticosteroids at physiological doses or systemic corticosteroids ≤10 mg/day of prednisone or equivalent.
Major surgery within 4 weeks prior to enrollment (excluding procedures for vascular access).
History or active autoimmune diseases within the past two years.
Trial design
Treatments tested in this trial
- Hypofractionated Radiation Therapy
- Conventionally Fractionated Radiation Therapy
- Concurrent Chemotherapy
- concurrent chemotherapy
- Consolidative immunotherapy
Treatment groups
311 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov