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

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study ID
NCT05766800
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Pemetrexed — DRUG
    Specified dose on specified days
  • Nab-paclitaxel — DRUG
    Specified dose on specified days
  • Liposomal paclitaxel — DRUG
    Specified dose on specified days
  • Surgery — PROCEDURE
    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.
  • Radiotherapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Mar 14, 2023
Status verified
Sep 2024
Primary completion
Apr 1, 2025
Completion
Apr 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Downstaged arm with surgical treatment
    In this arm, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.
  • Active Comparator: Downstaged arm with radiotherapy
    In this arm, patients with tumors resectable after chemoimmunotherapy will receive radiotherapy in department of medical oncology.
  • Other: Unresectable arm
    In this arm, patients with tumors still unresectable after chemoimmunotherapy will receive therapy in department of medical oncology.

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: Up to 30 months ]

Central Contacts

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