Clinical trial NCT05725915: Prediction Model of ICIs Combined With Chemotherapy in Advanced NSCLC
Official title: Multiparameter Prediction Model of Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Non-small Cell Lung Cancer: a Real-world Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer, Nonsmall Cell
Lead sponsor: Beijing Red Clove Public Welfare Development Center
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with inoperable stage IIIB to IV NSCLS using immune checkpoint inhibitors in combination with chemotherapy.

Brief summary: The reliable predictive markers to identify which patients with advanced non-small cell lung cancer tumors will achieve durable clinical benefit for chemo-immunotherapy are needed. This study is a real world study, aiming to establish a multi-parameter model to predict the efficacy of immune checkpoint inhibitor(ICI) combined with chemotherapy, and to explore the correlation and predictive value of each single biomarker, so as to assist physician to select patients who may benefit for a long time as early as possible and guide clinical accurate treatment.


Eligibility criteria: Inclusion Criteria:

1. Male and female, ≥18 years old;
2. Patients with a definite cytological or histopathological diagnosis of non-small cell lung cancer;
3. Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC unable to receive radical surgery and/or radical radiotherapy (with or without concurrent chemotherapy) (AJCC cancer stage 8 clinical stage)
4. There is no known ALK gene translocation
5. For patients with EGFR-negative non-squamous cell carcinoma, or patients with EGFR-negative/unknown squamous cell carcinoma, it is required that they have not received systemic antitumor therapy for advanced NSCLC in the past (patients have received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for curing non-metastatic disease in the past, A disease-free interval of ≥6 months was required between the last chemotherapy and/or radiotherapy).
6. Patients with non-squamous cell carcinoma with EGFR-sensitive mutation and EGFR TKI progression could be enrolled if they met any of the following requirements:

   Progress in Treatment of 1/2 generation EGFR TKI, T790M-; EGFR TKI treatment progress of 1/2 generation, T790M+, after 3 generations of EGFR TKI treatment progress again; T790M status was not considered in patients who had progressed to the initial 3 generations of EGFR TKI therapy.
7. At least 1 measurable lesion according to RECIST 1.1
8. Receiving immune checkpoint inhibitor therapy for more than 2 cycles
9. ECOG PS 0-1 score
10. Be able to understand and abide by the requirements of the agreement, and voluntarily participate in the study.

Exclusion Criteria:

1. Patients participating in other clinical studies;
2. Patients with serious lack of diagnosis and treatment data;
3. Patients could not understand the purpose of the study or disagreed with the requirements of the study;
4. A history of other tumors within 5 years;
5. Patients judged by the researchers as not suitable for inclusion in this study

Primary outcomes:
measure: Progression-free survival（PFS）in days
timeFrame: From date of enrollment until the date of first documented progression, assessed up to 2 years.
Secondary outcomes:
measure: ctDNA in concentration
timeFrame: The First treatment (month 1), the second treatment (month 2) and the time of progression (assessed up to 2 years)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Shuhua Han
state: Jiangsu
Study officials:
affiliation: Southeast University Zhongda Hospital
name: Shuhua Han, docter
role: STUDY_CHAIR
References: