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Efficacy and safety of immunotherapy in patients with NSCLC: a multicenter, observational clinical study

Efficacy and safety of immunotherapy in patients with NSCLC: a multicenter, observational clinical study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100054867
Enrollment
Unknown
Registered
2021-12-28
Start date
2021-12-30
Completion date
Unknown
Last updated
2022-12-12

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

Conditions

Lung cancer

Interventions

NSCLC group:No

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Over 18 years old (including 18 years old); 2. NSCLC diagnosed histologically or cytologically; 3. Patients receiving at least one immunotherapy; 4. At least one tumor lesion of the patient can be accurately measured at baseline, The longest diameter in the baseline period is >= 10 mm (in case of lymph nodes, the short diameter is required to be >= 15 mm). The selected measurement method is suitable for accurate repeated measurement, which can be computed tomography (CT) or magnetic resonance imaging (MRI). If there is only one measurable lesion, it can be accepted as the target lesion, and the baseline evaluation of tumor lesions needs to be performed at least 14 days after diagnostic biopsy; 5. NSCLC patients who meet any of the following: (1) Patients with advanced lung squamous cell carcinoma and EGFR/ALK wild type receiving immunotherapy; (2) Advanced non squamous NSCLC and EGFR/ALK wild-type patients receiving immunotherapy; (3) Patients with advanced NSCLC with EGFR/ALK sensitive mutations and receiving immunotherapy; (4) Patients with advanced NSCLC with other driver gene mutations and receiving immunotherapy; (5) NSCLC patients receiving immunoneoadjuvant therapy; (6) NSCLC patients receiving adjuvant therapy after immunosurgery; 6. The subjects voluntarily participated in this study.

Exclusion criteria

Exclusion criteria: 1. Suffering from active autoimmune diseases requiring systemic treatment; 2. There are serious systemic diseases, such as serious cardiac insufficiency, liver and kidney insufficiency, poorly controlled hypertension and other chronic diseases that affect the survival and prognosis of patients; 3. Active bleeding constitution or active fungal, bacterial and/or viral infection requiring systemic treatment; 4. Patients with a history of interstitial lung disease, drug-induced interstitial lung disease, interstitial pneumonia requiring steroid treatment or any evidence of clinically active interstitial lung disease affecting immunomedication; 5. Women of childbearing age did not take appropriate contraceptive measures from screening to 3 months after stopping the study treatment. The pregnancy test was positive before administration.

Design outcomes

Primary

MeasureTime frame
Progression-free survival ;Overall survival;Adverse events;

Secondary

MeasureTime frame
Objective response rate;Disease control rate;

Countries

China

Contacts

Public ContactJiang Liyan

Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University

jiang_liyan2000@126.com+86 13916146759

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026