Study of Chemotherapy and PD-1 Inhibitor Combination With Autologous CIK Cell Immunotherapy to Treat Lung Cancer (CCICC-002b)

A Randomized, Multicenter,Open-label Phase II Study is to Evaluate the Effects of Chemotherapy and Sintilimab or in Combination With Autologous Cytokine-induced Killer Cell Immunotherapy in Patients With Stage IV Non-small-cell Lung Cancer

This prospective,multicenter, open-labe phase II study is to evaluate the effects of autologous cytokine-induced killer cell immunotherapy combination with PD-1 inhibitor and chemotherapy in the first-line treatment of IV non-small cell lung cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer Metastatic; First-line Treatment
• Intervention / Treatment: Biological: CIK cell injection; Drug: Sintilimab Injection; Drug: Pemetrexed; Drug: Albumin paclitaxel; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiubao Ren, MD. Ph.D; Phone Number: 3173 86-22-23340123; Email: renxiubao@tjmuch.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Agreeing to participate in this study and signing a written informed consent. Male or female,from 18 to 75 years (including 18 and 75 years). The life expectancy will be longer than 3 months and can be followed up. Patients with stage IV NSCLC were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.

Initial medical treattment.Patients with adenocarcinoma need wild type of EGFR gene and ALK fusion gene negative to be included in this study.

ECOG score will be 0 or 1 within 7 days before randomization.

Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria:

White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range.

The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).

Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period.

Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.

Exclusion Criteria:

• Subjects who meet any of the following criteria could not participate in this study:

Adenocarcinoma subjects with EGFR sensitive mutation or ALK translocation; molecular detection of EGFR-sensitive mutations or ALK translocations is not required in squamous carcinoma patients.

NSCLC that had received chemotherapy in the past. Other malignant tumors needed treatment within five years. Allogeneic tissue/organ transplantation. Participating in research drug therapy within 4 weeks before the first administration of the trial.

Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy.

Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the drug; received chest radiotherapy greater than 30 Gy within 6 months before the first use of the drug; and received chest radiotherapy with 30 Gy or less within 1 month before the first use of the drug.

Previous treatment with PD-1/PD-L1 antibodies. Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment.

Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA > 10^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method.

Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.

Patients with active infections requiring systemic intravenous therapy. Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.

Subjects who are known to be allergic to any of the constituents of the drug being studied.

Subjects with a recent history of drug abuse (including alcohol) within one year.

Compliance is poor and can not cooperate with clinical research. Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: arm 1; IBI308 intravenous infusion 200mg d1; Pemetrexed intravenous infusion 500mg/m2 d2 or Albumin paclitaxel intravenous infusion 260mg/m2 d2; Carboplatin intravenous infusion AUC5 d2; CIK cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W.	Biological: CIK cell injection; CIK cells, more than 1x10^10 (10 billion ), intravenous infusion,d14; Q3W.; Other Names: Autologous cytokine-induced killer cells; Drug: Sintilimab Injection; Sintilimab Injection intravenous infusion 200mg d1; Other Names: PD-1 inhibitor; Drug: Pemetrexed; Pemetrexed intravenous infusion 500mg/m2 d2; Other Names: Pemetrexed injection; Drug: Albumin paclitaxel; Albumin paclitaxel intravenous infusion 260mg/m2 d2; Other Names: Albumin paclitaxel Injection; Drug: Carboplatin; Carboplatin intravenous infusion AUC5 d2; Other Names: Carboplatin injection
ACTIVE_COMPARATOR: arm 2; IBI308 intravenous infusion 200mg d1; Pemetrexed intravenous infusion 500mg/m2 d2 or Albumin paclitaxel intravenous infusion 260mg/m2 d2; Carboplatin intravenous infusion AUC5 d2;	Drug: Sintilimab Injection; Sintilimab Injection intravenous infusion 200mg d1; Other Names: PD-1 inhibitor; Drug: Pemetrexed; Pemetrexed intravenous infusion 500mg/m2 d2; Other Names: Pemetrexed injection; Drug: Albumin paclitaxel; Albumin paclitaxel intravenous infusion 260mg/m2 d2; Other Names: Albumin paclitaxel Injection; Drug: Carboplatin; Carboplatin intravenous infusion AUC5 d2; Other Names: Carboplatin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	ORR was calculated by the percentage of patients with a confirmed complete (CR) or partial response (PR).	Time Frame: 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from the first use of the study drug to the death of the subject	up to 3 years
Progression-free survival	Time from the first dose of study drug to the first disease progression (imaging)	up to 24 months

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Study Director: Liang Liu, MD. Ph.D, Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (ACTUAL): April 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Folic Acid Antagonists; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel; Pemetrexed; Immune Checkpoint Inhibitors
• Other Study ID Numbers: E20210014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This is a multicenter, prospective clinical trial. Eight centers provide data to each other.
• IPD Sharing Time Frame: 3 years
• IPD Sharing Access Criteria: All patients
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No