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

NCT05766800 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Serplulimab

Specified dose on specified days

DRUG

Carboplatin

Specified dose on specified days

DRUG

Pemetrexed

Specified dose on specified days

DRUG

Nab-paclitaxel

Specified dose on specified days

DRUG

Liposomal paclitaxel

Specified dose on specified days

PROCEDURE

Surgery

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.

RADIATION

Radiotherapy

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.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2025-04-01
Completion
2027-04-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05766800 on ClinicalTrials.gov