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

NCT04836728 | Active Not Recruiting Phase 2

• 1 other identifier: E20210014
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR was defined as the percentage of patients with a confirmed complete (CR) or partial response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator.

  Time Frame: Up to 24 months

Secondary Outcomes (6)

• Progression-free survival (PFS)

  up to 24 months

• Overall Survival (OS)

  up to 3 years

• Duration of response (DOR)

  up to 24 months

• Disease Control Rate (DCR)

  up to 24 months

• Number of Participants Who Experienced an Adverse Event (AE)

  up to 24 months (Serious AEs: Up to 90 days after last dose of study treatment (Other AEs: Up to 30 days after last dose of study treatment)

Study Arms (2)

CIK cells + Sintilimab + Platinum-based doublet chemotherapy

EXPERIMENTAL

Participants receive CIK cells for up to 8 cycles, in combination with sintilimab plus platinum-based chemotherapy (carboplatin and albumin paclitaxel for squamous NSCLC, or carboplatin and pemetrexed for non-squamous NSCLC), intravenously, every 3 weeks, for up to four cycles, followed by maintenance therapy with sintilimab for squamous NSCLC, and sintilimab plus pemetrexed for non-squamous NSCLC until disease progression or unacceptable toxicity or 2 years.

Biological: CIK cells injection; Drug: Sintilimab Injection; Drug: Pemetrexed; Drug: Albumin paclitaxel; Drug: Carboplatin

Sintilimab + Platinum-based doublet chemotherapy

ACTIVE COMPARATOR

Participants receive sintilimab plus platinum-based chemotherapy (carboplatin and albumin paclitaxel for squamous NSCLC, or carboplatin and pemetrexed for non-squamous NSCLC), intravenously, every 3 weeks, for up to four cycles, followed by maintenance therapy with sintilimab for squamous NSCLC, and sintilimab plus pemetrexed for non-squamous NSCLC until disease progression or unacceptable toxicity or 2 years.

Drug: Sintilimab Injection; Drug: Pemetrexed; Drug: Albumin paclitaxel; Drug: Carboplatin

Interventions

CIK cells injection BIOLOGICAL

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

Also known as: Autologous cytokine-induced killer cells

CIK cells + Sintilimab + Platinum-based doublet chemotherapy

Sintilimab Injection DRUG

200 mg, intravenous infusion, d1, every 3 weeks

Also known as: PD-1 inhibitor

CIK cells + Sintilimab + Platinum-based doublet chemotherapy; Sintilimab + Platinum-based doublet chemotherapy

Pemetrexed DRUG

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

Also known as: Pemetrexed injection

CIK cells + Sintilimab + Platinum-based doublet chemotherapy; Sintilimab + Platinum-based doublet chemotherapy

Albumin paclitaxel DRUG

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

Also known as: Albumin paclitaxel Injection

CIK cells + Sintilimab + Platinum-based doublet chemotherapy; Sintilimab + Platinum-based doublet chemotherapy

Carboplatin DRUG

AUC 5, intravenous infusion, d1, every 3 weeks

Also known as: Carboplatin injection

CIK cells + Sintilimab + Platinum-based doublet chemotherapy; Sintilimab + Platinum-based doublet chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent prior to any trial-related procedures.
• Age ≥18 and ≤75 years.
• Histologically or cytologically confirmed stage IV NSCLC (IASLC/UICC 8th edition TNM staging) with no prior systemic therapy for advanced disease.
• For enrolled adenocarcinoma patients: Absence of EGFR-sensitive mutations and ALK gene fusion alterations confirmed by histological specimens.
• At least one radiologically measurable lesion per RECIST v1.1. Lesions within prior radiotherapy fields may be considered measurable if progression is confirmed.
• No prior systemic antitumor therapy for advanced/metastatic disease. Subjects who received:
• Platinum-based adjuvant/neoadjuvant chemotherapy, or
• Definitive chemoradiotherapy for limited-stage disease are eligible if disease progression/recurrence occurred ≥6 months after last chemotherapy.
• Asymptomatic or stable brain metastases after local treatment are permitted if all criteria are met:
• Measurable extracranial lesions
• No CNS symptoms or symptom stability for ≥2 weeks
• No corticosteroids required, OR discontinued corticosteroids ≥7 days before first dose, OR stable corticosteroid dose ≤10 mg/day prednisone equivalent for ≥7 days.
• Palliative radiotherapy (including brain RT for symptomatic metastases) is allowed if completed ≥1 week before first dose and radiation-related toxicities have recovered to ≤Grade 1 (CTCAE v5.0, excluding alopecia).
• ECOG performance status 0-1.
• Life expectancy \>3 months.

You may not qualify if:

• Pathologically confirmed small cell lung cancer (SCLC), including mixed SCLC-NSCLC histology.
• Prior radiotherapy meeting any of the following:
• Radiation to ≥30% of bone marrow within 14 days before first dose
• Lung radiation \>30 Gy within 6 weeks before treatment (subjects must have recovered to ≤Grade 1 toxicity, no corticosteroid requirement, and no history of radiation pneumonitis)
• Palliative radiotherapy completed ≤7 days before first dose
• Diagnosis of malignancies other than NSCLC within 5 years before first dose (except cured basal cell carcinoma, squamous cell carcinoma, or resected carcinoma in situ).
• Current participation in interventional clinical trials or receipt of investigational drugs/devices within 4 weeks before first dose.
• Prior therapy with anti-PD-1/PD-L1/PD-L2 agents or drugs targeting other T-cell co-stimulatory/checkpoint pathways (e.g., CTLA-4, OX-40, CD137).
• Systemic treatment with Chinese herbal medicines (for lung cancer indications) or immunomodulatory agents (e.g., thymosin, interferon, interleukin) within 14 days before first dose (except local pleural control).
• Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within 2 years before first dose. Replacement therapies (e.g., thyroid hormone, insulin, physiologic corticosteroids) are permitted.
• Systemic corticosteroids (\>10 mg/day prednisone equivalent) or immunosuppressive therapy within 7 days before first dose (excluding topical/nasal/inhaled corticosteroids).
• \*Note: Physiologic corticosteroid doses (≤10 mg/day prednisone equivalent) are allowed.\*
• Clinically uncontrolled pleural/peritoneal effusion (subjects with stable effusion not requiring drainage or ≥3 days post-drainage may enroll).
• History of allogeneic organ transplantation (except corneal transplants) or hematopoietic stem cell transplantation.
• Known hypersensitivity to sintilimab, pemetrexed, nab-paclitaxel, carboplatin, or their excipients.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Interventions

sintilimab; Immune Checkpoint Inhibitors; Pemetrexed; Carboplatin

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Liang Liu, MD. Ph.D

  Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: March 31, 2021
• Primary Completion: April 30, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years
• Access Criteria: All patients

Locations

CN (1)