A Study of Anti-PD1 Antibody-activated TILs in Non-small Cell Lung Cancer

NCT03903887 | Unknown Phase 1

• 1 other identifier: B2018-149-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a phase I/II trial initiated by the investigator to evaluate the safety and tolerability of anti-PD-1 antibody-activated TILs combined with adjuvant chemotherapy in participants with stage II-IIIA non-small cell lung cancer. 20 participants were enrolled and anti-PD-1 antibody-activated TILs was infused into participants after the final cycle chemotherapy to assess the safety and disease-free survival.

Conditions

Non-small Cell Lung Cancer

Keywords

Lung Cancer; TIL; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Severity of adverse events

  According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

  3 weeks

Secondary Outcomes (3)

• Disease-free survival (DFS)

  6 months

• Overall survival (OS)

  12 months

• The quality of life by EQ-5D-5L (EuroQol Group, Chinese versions )

  3 weeks

Study Arms (1)

PD1-TIL combined with chemotherapy

EXPERIMENTAL

Participants would receive anti-PD1 antibody-activated TILs after the final cycle of adjuvant chemotherapy.

Biological: anti-PD1 antibody-activated TILs

Interventions

anti-PD1 antibody-activated TILs BIOLOGICAL

Participants would receive one dose of anti-PD1 antibody-activated TILs at the final cycle of docetaxel and cisplatin (DP) regimen chemotherapy.

PD1-TIL combined with 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:

• Participants with stage II-IIIA non-small cell lung cancer and scheduled to receive adjuvant chemotherapy postoperation.
• Age 18 to 75 years.
• Willing to sign a durable power of attorney.
• Able to understand and sign the Informed Consent Document.
• Life expectancy of greater than six months.
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen.
• Adequate organ function.
• Serology:
• Seronegative for HIV antibody. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
• Hematology:
• white blood cell count (\> 3500/mm(3)). Platelet count greater than 100,000/mm(3). Hemoglobin greater than 9.0 g/dl.
• Chemistry:
• Serum Alanine aminotransferase/Aspartate aminotransferase less or equal to 2.5 times the upper limit of normal.
• Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl.

You may not qualify if:

• Previous treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) , anti-PD-1, and anti-Programmed death-ligand 1(PD-L1).
• Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
• Allogeneic tissue/organ transplantation.
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
• History of autoimmune disease
• Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
• Concurrent antineoplastic therapies and systemic steroid therapy.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Biotherapy

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 4, 2019
• Study Start: February 19, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2021
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

CN (1)