RecruitingPhase 2NCT05766800

Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer

Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial


Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

100 participants

Start Date

Mar 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

For unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy (a PD-1 antibody) combined with platinum-based chemotherapy before radiation can improve outcomes in patients with locally advanced non-small cell lung cancer (NSCLC) that hasn't spread to distant organs. **You may be eligible if...** - You are 18 or older - You have been diagnosed with NSCLC at stage IIIB or IIIC (locally advanced, not yet spread distantly) - You are in good overall health (ECOG 0–1) - Your cancer has at least one measurable area on scans - Your lung function is good enough to tolerate surgery - Your liver, kidney, and blood counts are adequate **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body - You have poor lung function or health status - You have had prior treatment for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerplulimab

Specified dose on specified days

DRUGCarboplatin

Specified dose on specified days

DRUGPemetrexed

Specified dose on specified days

DRUGNab-paclitaxel

Specified dose on specified days

DRUGLiposomal paclitaxel

Specified dose on specified days

PROCEDURESurgery

Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.

RADIATIONRadiotherapy

Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, China

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NCT05766800


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