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NCT06109402Not yet recruitingPhase 2

Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 19 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

For resectable non-small cell lung cancer, neoadjuvant immunochemotherapy plus adjuvant immunotherapy or adjuvant immunochemotherapy is usually used in clinical practice. However, it is unclear whether therapeutic strategy is superior. This trial aims to compare the efficacy and safety of these two strategies.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
160 (estimated)
First submitted
26 Oct 2023
Start date
Dec 2023
Primary completion date
Nov 2030
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Diseases
Lung cancer
NCT number
NCT06109402

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 160
  • From Dec 2023 to the primary completion date, Nov 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
  • Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;

Other illness

  • With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
  • Participants who are allergic to the test drug or any auxiliary materials;
  • Participants with Interstitial lung disease currently;
  • Participants with active hepatitis B, hepatitis C or HIV;
  • Participants suffering from nervous system diseases or mental diseases that cannot cooperate;

Other

  • Pregnant or lactating women;
  • Participated in another therapeutic clinical study;
  • Other factors that researchers think it is not suitable for enrollment.

Who the study is looking for

  • The patient shall sign the Informed Consent Form.
  • Aged 18 ≥ years.
  • Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-IIIB (N2) confirmed by imageological examinations (CT, PET-CT or EBUS).
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
  • Life expectancy is at least 12 weeks.
  • At least 1 measurable lesion according to RECIST 1.1.
  • Patients with good function of other main organs (liver, kidney, blood system, etc.)
  • Patients with lung function can tolerate surgery;
  • Without systematic metastasis (including M1a, M1b and M1c);
  • Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of immunotherapy (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
  • Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of immunotherapy (whichever is later).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Pulmonary Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.