Anti-PD-1 Alone or Combined With Autologous Cell Therapy in Advanced NSCLC

NCT03360630 | Completed Phase 1

• 1 other identifier: PD-1 plus DC-CIK for NSCLC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled study to compared the clinical effects and safety of immunotherapy with dendritic cells and cytokine-induced killer cells administered with anti-PD-1 antibody in advanced NSCLC.

Conditions

Lung Cancer; Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression-free survival of the participants

  From starting date of anti-PD-1 antibody treatment until date of until the date of first documented disease progression or date of death from any cause, whichever comes first.

  12 months

Secondary Outcomes (4)

• Overall survival of the participants(OS)

  24 months

• Assessment of Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PROCTCAE)

  24 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  24 months

• Molecular Tumor Burden Index

  24 months

Other Outcomes (4)

• Cell-free tumor DNA

  24 months

• Tumor related antigen peptides

  24 months

• T cell metaboic activity

  24 months

Study Arms (2)

Anti-PD-1 plus DC-CIK

EXPERIMENTAL

Biological: Anti-PD-1 plus DC-CIK

Anti-PD-1 alone

ACTIVE COMPARATOR

Biological: Anti-PD-1 alone

Interventions

Anti-PD-1 plus DC-CIK BIOLOGICAL

Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal. DC-CIK Immunotherapy: Mononuclear cells were collected aseptically with blood cell separator composition apheresis, and cultured DC-CIK cells for 10-14 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible.

Anti-PD-1 plus DC-CIK

Anti-PD-1 alone BIOLOGICAL

Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.

Anti-PD-1 alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed advanced or metastatic NSCLC.
• Patients must have received previously standard therapy for that malignancy or declined to chemotherapy/radiotherapy.
• Estimated life expectancy \> 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
• Age 18 to 80.
• Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR \<1.5 (unless patient is receiving warfarin in which case PT-INR must be \<3), PTT \<1.5X ULN
• Adequate renal and hepatic function, with serum creatinine \< 1.5 mg/ dL, bilirubin \< 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.

You may not qualify if:

• Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
• Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
• Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
• Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated.
• Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
• Patients on chronic steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies or for acute treatment (\<5 days) of intercurrent medical condition such as a gout flare) prior to enrollment.
• Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
• Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.

Sponsors & Collaborators

• Capital Medical University: lead
• Duke University: collaborator
• Geneplus-Beijing Co. Ltd.: collaborator

Study Sites (1)

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Beijing, 100038, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Comprehensive Cancer Center

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 4, 2017
• Study Start: November 1, 2016
• Primary Completion: December 31, 2022
• Study Completion: June 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)