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Dynamic PET/CT Evaluated the Response of Neoadjuvant Anti-PD1 Combination With Chemotherapy for Ⅱa-Ⅲb NSCLC

NCT04586465 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-08-24

No results posted yet for this study

Summary

The neoadjuvant Immune Checkpoint Inhibitor (ICI) or ICI combination with chemotherapy for Non-small cell lung cancer (NSCLC) had induced higher major pathologic response (MPR) and complete pathological response (PCR). However, the RECIST underestimated the therapeutic response of neoadjuvant ICI therapy. In this study, dynamic PET/CT compared with RECEST 1.1 for the prediction of therapeutic response of NSCLC treated with neoadjuvant ICI combination with chemotherapy.

Conditions

  • Non-small Cell Lung Cancer Stage II
  • Non-small Cell Lung Cancer Stage III
  • PET/CT

Interventions

DRUG

pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatin

Patients will receive 3 cycles pembrolizumab 200mg, fix dose, 60 minute IV infusion combination with chemotherapy. Chemotherapy regimen: ① Eligible patients with non-squamous cell lung cancer, Pemetrexed 500mg/m2, IV infusion on day 1 and cisplatin 75mg/m2 or carboplatin area under the curve (AUC=5), on day 1 of a 3-week schedule for 3 cycles. ② Eligible patients with squamous cell lung cancer. Patients will receive gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 or carboplatin AUC=5 on day 1 of a 3-week schedule for 3 cycles

Sponsors & Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-10
Primary Completion
2021-11-30
Completion
2022-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT04586465 on ClinicalTrials.gov