Integrative Multi-Omics Testing for Immunotherapy Response in Non-Small Cell Lung Cancer
NCT ID: NCT05928299
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2020-01-01
2025-12-31
Brief Summary
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Detailed Description
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For the part of retrospective study，the investigators intend to include 200 patients who received immunotherapy at Nanfang Hospital from January 1, 2020 to March 1, 2023.
For the part of prospective study，the investigators intend to include 200 patients who will receive immunotherapy at Nanfang Hospital from March 1, 2023 to December 31, 2025.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Durable Clinical Benefit
PFS≥ 6 months
No interventions assigned to this group
Non-durable Clinical Benefit
PFS\< 6 months
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patients with histologically or cytologically confirmed non-small cell lung cancer that is metastatic or locally advanced unresectable, not eligible for local curative treatment (Stage IIIB or IV according to AJCC);
3. Patients without contraindications for immunotherapy according to CSCO guidelines for Non-Small Cell Lung Cancer (NSCLC) version 2022（No EGFR mutations, ALK or ROS1 rearrangement);
4. Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1;
5. Patients who have not received systemic treatment in the past, or who have previously received (neo) adjuvant treatment/radical treatment programs and have relapsed for more than 6 months;
6. Patients who signed the informed consent and are willing to participate in the study.
Exclusion Criteria
2. Any severe, uncontrolled diseases, including: (1) Active or uncontrolled heart diseases, (2) Renal failure requires hemodialysis or peritoneal dialysis; (3) Liver diseases such as liver cirrhosis, decompensated liver disease, chronic active hepatitis;
3. Any severe, uncontrolled urological diseases, or urine total protein \>1.0g/day.
4. Any severe, uncontrolled metabolic diseases, including uncontrolled diabetes mellitus (fasting blood glucose (FBG)\>10mmol/L);
18 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Nanfang hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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NFEC-2023-128
Identifier Type: -
Identifier Source: org_study_id
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