Prospective Observation of Failure Patterns in NSCLC Treated With ICIs

NCT04492969 | Unknown

• 1 other identifier: 2019-CSCOBMS
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

By prospectively observing the time to the best therapeutic effect of non-small cell lung cancer after ICI treatment, the characteristics of lesion distribution when the best therapeutic effect is reached, and the phenotype of disease progression after ICI treatment response, the investigators intended to explore the failure pattern of NSCLC after the once effective ICI treatment. The investigators also aim to evaluate the feasibility and clinical value of radiotherapy for the treatment of oligo-progressive lesions after ICI.

Conditions

NSCLC Stage IV; NSCLC, Recurrent

Outcome Measures

Primary Outcomes (1)

• Oligo-progression disease rate in NSCLC patients developing acquired resistance to ICI treatment.

  Acquired resistance (AR) was defined as disease progression after partial or complete response (PR or CR) to ICI treatment. (by RECIST standard v1.1) When observing disease progression in ICI treatment, the number and distribution of progression lesions were recorded. Oligo-progression disease (OPD) was defined as 1-3 progression lesions in 1-2 organs. The OPD rate in all AR cases will be calculated.

  at least 2 months after ICI treatment.

Secondary Outcomes (4)

• Overall objective response rate to radiotherapy.

  at least 4 weeks after radiotherapy.

• Objective response rate in non-irradiated lesion

  at least 4 weeks after radiotherapy.

• Percentage of Participants With Adverse Events

  Two years

• Overall Survival since AR development.

  Two years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

stage IV NSCLC developing acquired resistance under ICI treatment.

You may qualify if:

• Age between 18 and 75 years.
• ECOG PS 0-1.
• Pathologically confirmed stage IV NSCLC.
• Negative for driver genes including EGFR, ALK, and ROS-1.
• Patients achieved PR or CR after ICI treatment, as defined by RECIST 1.1.
• Patients with complete radiological information of baseline lesions.
• Life expectancy of more than 3 months.
• Ability to understand and willingness to provide the informed consent.

You may not qualify if:

• Severe autoimmune disease or other contradictions to ICI treatment.
• Mixed small cell with non-small cell lung cancer histology.
• Driver gene positive, including EGFR, ALK, and ROS-1.
• Pregnant or lactating women.
• History of any other malignancy.
• Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
• Patients receiving immunosuppressive agents,or other investigational treatment. Long-term corticosteroid users are also excluded.
• Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
• Patients with oligo-progression disease (1-3 progression lesions in 1-2 organs) when developing acquired resistance to ICI.
• Radiotherapy to at least one of the OPD lesions is indicated in the opinion of the investigator. At least one of the irradiated lesion(s) should be evaluable according to RECIST 1.1.
• ECOG PS 0-2.
• Life expectancy of more than 3 months.
• Complete radiological information of all lesions during the follow-up.
• Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
• Adequate bone marrow function within 1 week prior to the enrollment: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, and platelet count ≥ 100 \* 10 \^ 9/L;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhengfei Zhu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengfei Zhu, MD

CONTACT

+86-18017312901; fuscczzf@163.com

Xiao Chu, PhD

CONTACT

+86-15821383376; crazychu0044@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: September 1, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2025
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

CN (1)