Exploration of Predictive Markers of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer
NCT ID: NCT05965557
Last Updated: 2025-09-04
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
100 participants
OBSERVATIONAL
2023-06-19
2025-12-31
Brief Summary
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This study intends to prospectively collect patients with driver-negative stage II-IIIB NSCLC who are scheduled to receive neoadjuvant immunotherapy and surgical resection and verify the value of HRD in predicting the efficacy of neoadjuvant immunotherapy. Meanwhile, the blood samples before and after neoadjuvant immunotherapy were collected for high-depth ctDNA detection to explore the correlation between the dynamic changes of ctDNA and the efficacy and prognosis of neoadjuvant immunotherapy.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* EGFR/ALK negative
* The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up
Exclusion Criteria
* Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy
18 Years
80 Years
ALL
No
Sponsors
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Geneplus-Beijing Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Chest Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhou Z, Ding Z, Yuan J, Shen S, Jian H, Tan Q, Yang Y, Chen Z, Luo Q, Cheng X, Yu Y, Niu X, Qian L, Chen X, Gu L, Liu R, Ma S, Huang J, Chen T, Li Z, Ji W, Song L, Shen L, Jiang L, Yu Z, Zhang C, Tai Z, Wang C, Chen R, Carbone DP, Xia X, Lu S. Homologous recombination deficiency (HRD) can predict the therapeutic outcomes of immuno-neoadjuvant therapy in NSCLC patients. J Hematol Oncol. 2022 May 18;15(1):62. doi: 10.1186/s13045-022-01283-7.
Provencio M, Nadal E, Insa A, Garcia-Campelo MR, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Anton C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermudez A. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24.
Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.
Other Identifiers
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PROMISEPLUS-101
Identifier Type: -
Identifier Source: org_study_id
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