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Phase II Study of Chemotherapy and PD-1 Inhibitor Combination With Autologous CIK Cell Immunotherapy to Treat Lung Cancer

NCT04836728 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-03-13

No results posted yet for this study

Summary

This prospective, multi-center, open-label, phase II, randomized controlled trial (CCICC-002b) is to evaluate the efficacy and safety of autologous cytokine-induced killer cell immunotherapy in combination with PD-1 inhibitor and platinum-containing chemotherapy in the first-line treatment of stage IV non-small cell lung cancer (NSCLC).

Conditions

  • Non-small Cell Lung Cancer Metastatic
  • First-line Treatment

Interventions

BIOLOGICAL

CIK cells injection

CIK cells, more than 1x10\^10 (10 billion ), intravenous infusion, d14, Q3W.

DRUG

Sintilimab Injection

200 mg, intravenous infusion, d1, every 3 weeks

DRUG

Pemetrexed

500 mg/m\^2, intravenous infusion, d1, every 3 weeks

DRUG

Albumin paclitaxel

260 mg/m\^2, intravenous infusion, d1, every 3 weeks

DRUG

Carboplatin

AUC 5, intravenous infusion, d1, every 3 weeks

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Liang Liu, MD. Ph.D · Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2024-04-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04836728 on ClinicalTrials.gov