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RecruitingNCT05965557Updated Jun 30, 2026

Exploration of Predictive Markers of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer

An observational study in Lung Cancer, sponsored by Geneplus-Beijing Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Geneplus-Beijing Co. Ltd. · Observational

From the registry’s dates

  • Started Jun 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
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Study summary

Neoadjuvant immunotherapy has become the standard perioperative treatment in lung cancer, but its effective predictive biomarkers are lacking. A small cohort reported that homologous recombination deficiency (HRD) can be used as a reliable biomarker to predict the efficacy of neoadjuvant immunotherapy, but the findings need to be validated in larger cohorts. Moreover, circulating tumor DNA (ctDNA) has the potential to predict the therapeutic efficacy of neoadjuvant immunotherapy.

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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Conditions studied

  • Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 100 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Geneplus-Beijing Co. Ltd. is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Stage II-IIIB NSCLC who are undergoing neoadjuvant immunotherapy and surgical resection

Inclusion criteria

  • Stage II-IIIB NSCLC
  • EGFR/ALK negative
  • The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up

Exclusion criteria

Exclusion Criteria:

  • A history of other malignancies within the past 5 years
  • Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Correlation between HRD and MPR rate/2 years DFS

    Correlation between homologous recombination deficiency (HRD) events and major pathological response (MPR) rate and DFS of 2 years

    Time frame: 2023/12-2025/12

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Study locations

1 of 1 sites recruiting
  • Shanghai Chest Hospital
    Shanghai, China
    Recruiting
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References and documents

Publications

  • 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. PubMed 35585646 ↗
  • 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. PubMed 32979984 ↗
  • 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. PubMed 35403841 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05965557
Lead sponsor
Geneplus-Beijing Co. Ltd.
Responsible party
Sponsor
First posted
Jul 28, 2023
Start date
Jun 19, 2023
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 30, 2026

Study contacts

Shun Lu, PhD
Contact
shunlu@sjtu.edu.cn
+86 18017321551

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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