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Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC

ConditionLocally Advanced Non-Small Cell Lung Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Hypofractionated Radiation Therapy

    Radiation

    All patients will receive split-course hypofractionated radiotherapy. First course of radiotherapy: Total dose of 4000 cGy in 10 daily fractions (400 cGy per fraction) or 3000 cGy in 6 daily fractions (500 cGy per fraction). Three weeks after the completion of the first course of hypofractionated radiotherapy, tumor response and toxicity will be evaluated. For patients who achieve a partial response and without grade 2 or higher respiratory toxicity, a second course of radiotherapy will be planned for the residue disease at a total dose of 2000 \~2400 cGy in 5\~6 fractions (400 cGy per fraction). The interval between the two courses of radiotherapy will be 28 days.

  • Conventionally Fractionated Radiation Therapy

    Radiation

    Patients in this group will receive a total dose of 6000- 6400 cGy in 30- 32 fractions, with 200 cGy per fraction.

  • Concurrent Chemotherapy

    Drug

    Paclitaxel plus platinum-based chemotherapy.

  • concurrent chemotherapy

    Drug

    Paclitaxel plus platinum-based chemotherapy or pemetrexed plus platinum-based chemotherapy.

  • Consolidative immunotherapy

    Drug

    Following the completion of chemoradiotherapy, PD-1/PD-L1 immune checkpoint inhibitor consolidation therapy will be administered for up to 12 months.

Treatment groups

311 Participants
are divided into 2 treatment groups
Group A: Hypofractionated CCRTExperimental treatment 3 interventions
Group B: Conventional fractionated CCRTActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Median Progression-Free Survival

PFS measures the time from the start of treatment until the disease progresses or the patient dies from any cause, whichever occurs first.

Time frame
2 years

Secondary outcomes

1

Objective Response Rate (ORR)

ORR refers to the proportion of patients who experience complete response (CR) and partial response (PR)

Time frame
1-2 months after treatment
2

Overall survival (OS)

OS is the time from the start of treatment until death from any cause.

Time frame
2 years
3

Failure patterns

Failure patterns describe the pattern of disease progression or treatment failure, such as local recurrence or distant metastases.

Time frame
2 years
4

Safety: Adverse Events

Safety endpoints assess the frequency and severity of treatment-related adverse events. Adverse events are graded on a scale from 1 to 5 according to CTCAE 5.0.

Time frame
1 years after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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