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A study on the timing of CDK4/6 inhibitor combined chemotherapy based on RB1 phenotype in the treatment of non-small cell lung cancer

A study on the timing of CDK4/6 inhibitor combined chemotherapy based on RB1 phenotype in the treatment of non-small cell lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129296
Enrollment
Unknown
Registered
2026-08-03
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Standard chemotherapy group:None
The sequential CDK4/6 inhibitor group after chemotherapy:None

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 75 years old, gender not limited; 2.Histopathologically or cytologically confirmed non-small cell lung cancer, including lung adenocarcinoma, lung squamous cell carcinoma, or other types of non-small cell lung cancer. 3.Clinical stage is locally advanced unresectable, recurrent, or metastatic non-small cell lung cancer. 4.Previously received at least 2 cycles of standard chemotherapy, including platinum-based doublet chemotherapy or clinically commonly used single-agent/combination chemotherapy regimens. 5.At least one set of imaging data available for efficacy evaluation before or during treatment. 6.Accessible tumor tissue paraffin blocks or unstained slides available for immunohistochemical detection of RB, pRB, p16, Cyclin D1, CDK4, CDK6, Ki-67, etc., or prior next-generation sequencing data available for RB1 and related pathway analysis. 7.Relatively complete clinical data, including age, sex, smoking history, ECOG score, pathological type, TNM stage, driver gene status, number of treatment lines, chemotherapy regimen, adverse reactions, efficacy evaluation, and follow-up outcomes.

Exclusion criteria

Exclusion criteria: 1.Pathological type is small cell lung cancer, pulmonary neuroendocrine carcinoma, or mixed lung cancer containing small cell lung cancer components. 2.Severe lack of clinical data, making it impossible to determine treatment plan, efficacy, or survival outcomes. 3.Insufficient imaging data to evaluate efficacy according to RECIST 1.1 criteria. 4.Poor quality of pathological tissue, unable to complete RB1 phenotype-related testing. 5.Concurrent other malignant tumors and inability to determine whether survival outcomes are primarily determined by non-small cell lung cancer. 6.The investigator determines that it is unsuitable for inclusion in the analysis.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Disease control rate;Progression free survival;Overall survival;Duration of relief;

Countries

China

Contacts

Public ContactXiao Hui

Shanghai General Hospital

xiaohui771210@163.com+86 21 37798587

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026